Fabrication of Complete/partial Dentures (Different Final Impression Techniques and Materials) For Treating Edentulous Patients (Protocol)

Cochrane Database of Systematic Reviews
Fabrication of complete/partial dentures (different final

impression techniques and materials) for treating edentulous
patients (Protocol)
Jayaraman S, Singh BP, Ramanathan B, Pazhaniappan Pillai M, Kirubakaran R
Jayaraman S, Singh BP, Ramanathan B, Pazhaniappan Pillai M, Kirubakaran R.

Fabrication of complete/partial dentures (different final impression techniques and materials) for treating edentulous patients.
Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012256.
DOI: 10.1002/14651858.CD012256.
www.cochranelibrary.com
Fabrication of complete/partial dentures (different final impression techniques and materials) for treating edentulous patients (Protocol)
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Fabrication of complete/partial dentures (different final impression techniques and materials) for treating edentulous patients (Protocol) i
[Intervention Protocol]
Fabrication of complete/partial dentures (different final

impression techniques and materials) for treating edentulous
patients
Srinivasan Jayaraman1 , Balendra P Singh2 , Balasubramanian Ramanathan3 , Murukan Pazhaniappan Pillai4 , Richard Kirubakaran5
1 Department of Prosthodontics and Oral Implantology, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth University,
Pondicherry, India. 2 Prosthodontics, and Crowns & Bridges, King George’s Medical University, Lucknow, India. 3 Department of
Prosthodontics, Rajah Muthiah Dental College & Hospital, Annamalai Nagar, India. 4 Department of Prosthodontics, M.E.S. Dental
College, Malappuram, India. 5 South Asian Cochrane Network & Center, Prof. BV Moses Center for Evidence-Informed Health Care
and Health Policy, Christian Medical College, Vellore, India
Contact address: Srinivasan Jayaraman, Department of Prosthodontics and Oral Implantology, Indira Gandhi Institute of Dental
Sciences, Sri Balaji Vidyapeeth University, Kirumambakkam, Pondy-Cuddalore Main Road, Pondicherry, Puducherry, 607402, India.
srinivasanj@igids.ac.in. srini_rajee@yahoo.co.in.
Editorial group: Cochrane Oral Health Group.

Publication status and date: New, published in Issue 6, 2016.
Citation: Jayaraman S, Singh BP, Ramanathan B, Pazhaniappan Pillai M, Kirubakaran R. Fabrication of complete/partial dentures
(different final impression techniques and materials) for treating edentulous patients. Cochrane Database of Systematic Reviews 2016,
Issue 6. Art. No.: CD012256. DOI: 10.1002/14651858.CD012256.
ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To assess the effects of different final impression techniques and materials used in the fabrication of complete dentures for retention,
stability, comfort and quality of life in completely edentulous patients.
To assess the effects of final impression techniques and materials used for fabrication of removable partial dentures in partially edentulous
patients for stability, comfort, overextension and quality of life in partially edentulous patients.
BACKGROUND timated to surpass two billion by 2050 (United Nations 2013).

Edentulism is among the 50 most common diseases, affecting
2.3% of the total global population in 2010 (Vos 2012). The
Description of the condition prevalence of partially and completely edentulous patients is likely
to increase, as the chance of tooth loss increases with age (Urzua
2012). Complete edentulism is a chronic and irreversible condi-
tion, having a major impact on the oral and general health of an
Complete denture/partial denture
individual (Atwood 1971; Gift 1992). The global prevalence of
The increase in life expectancy in developed and developing coun- complete edentulousness ranges from about 3% to 21% and varies
tries means that the global population over 60 years of age is es-
Fabrication of complete/partial dentures (different final impression techniques and materials) for treating edentulous patients (Protocol) 1
with age, sex, socioeconomic status, education, dental awareness, of a tray, followed by final impression) (Trapozzano 1939). The
patient/dentist ratio and demography (Cunha-Cruz 2007; Peltzer final impression materials and techniques used for complete den-
2014; Steele 2012). The condition affects individuals’ diet and tures date back to 1900 (Paulino 2015; Zinner 1981). Practition-
nutritional status (Hutton 2002; Lee 2004), and patients who are ers make the impression using either the open mouth or the closed
edentulous may also have comorbid conditions that worsen their mouth approach in one or two steps (Boucher 1951). The single
adaptation to complete dentures as they age (Emami 2013). The step procedure involves simultaneous border moulding and the
only cost-effective non-implant treatment to restore dentition is final impression using the same material, either a resinous wax or
a complete, removable dental prosthesis or a complete denture a monophase elastomer (Joglekar 1968; Loh 1997; Minagi 1987).
(MacEntee 1998), which is defined as “a removable dental pros- The two-step final impression technique begins with separate bor-
thesis that replaces the entire dentition and associated structures der moulding, followed by the final impression procedure (Chaffee
of the maxillae or mandible” (The glossary of prosthodontic terms 1999; Friedman 1957; Smith 1979). Border moulding is defined
2005). as “the shaping of the border areas of an impression material by
The prevalence of partial edentulousness also increases with age functional or manual manipulation of the soft tissue adjacent to
and is more prevalent than complete edentulousness (Jeyapalan the borders to duplicate the contour and size of the vestibule” (The
2015; Tanasi 2015; Slade 2014). The partial loss of teeth may be glossary of prosthodontic terms 2005). It can be accomplished by
replaced by fixed or removable treatment options based on number using either a sectional technique or the single-step technique us-
of teeth lost and condition of the residual ridge of the patient. The ing different types of materials. These techniques may be further
loss of teeth correlates with an increase in obesity and a decrease classified as operator-manipulated or functionally moulded, based
in people’s nutritional status, psychological self image and quality on the condition of the ridge and operators’ preference. In terms of
of life (Emami 2013; Friedman 2014; Gil-Montoya 2015; Goel materials, the sectional technique involves recording the borders
2016; Hilgert 2009; Huang 2013; Hugo 2009; Kandelman 2008; in sections using a low-fusing impression compound (Friedman
Rodrigues 2012; Roohafza 2015). 1957). The single-step border moulding technique uses polyether
and addition silicone of differing viscosities (Chaffee 1999; Smith
1979; Solomon 1973; Solomon 2011). Clinicians can make the
final impression (sometimes referred to as the wash impression)
Description of the intervention
for complete dentures using different techniques and materials
(Starcke 1975). These have evolved along with our understand-
ing of the biology of the tissues and advances in the available ma-
Complete denture terials. The techniques can be grouped into mucostatic, muco-
A dental impression is defined as “a negative imprint of an oral compressive, selective pressure, functional and neutral zone im-
structure used to produce a positive replica of the structure to pression (Figure 1; Addison 1944; Beresin 1976; Boucher 1943;
be used as a permanent record or in the production of a dental Cagna 2009; Freeman 1969; Solomon 1973). The materials used
restoration or prosthesis” (The glossary of prosthodontic terms are impression plaster, resinous wax, zinc oxide eugenol impres-
2005). Dental practitioners can make the impression in a single sion paste, alginate, polysulphide, addition silicone and polyether
stage (abbreviated impression) or in two stages (preliminary im- (Figure 2; Boucher 1951; Daou 2010; Joglekar 1968; Koran 1977;
pression made for the purposes of diagnosis or for the construction Mehra 2014; Trapozzano 1939).
Figure 1. Complete denture final impression techniques (Al-Ahmar 2008,Drago 2003; Freeman 1969;
Paulino 2015; Petropoulos 2003)
Figure 2. Impression materials for complete denture and removable partial denture (Freeman 1969;
Phoenix 2008)
special or dual impression procedure is indicated due to the rel-

Removable partial denture
ative discrepancy in the degree of movement occurring between
The distribution of the occlusal forces varies based on the con- the tooth and mucosa covering the ridge in response to occlusal
dition of the partially edentulous state in removable cast partial forces (Hindels 1957). The different techniques are classified into
dentures (RPD). In a tooth-supported partial denture, the occlusal physiologic and selective pressure impression techniques (Phoenix
forces are mainly distributed to the abutment teeth and less onto 2008). The physiologic impression techniques are the McLean-
the edentulous ridge, so the final impression is used to record the Hindels technique, the functional reline method and the fluid
tissues in their anatomic state in order to produce an accurate wax impression (altered cast) techniques (Figure 3). In the selec-
master cast (Applegate 1960; Leupold 1966). The materials and tive pressure technique, the ridge is selectively relieved to redi-
techniques used for recording final impression in tooth-supported rect forces to stress-bearing areas during impression (Akerly 1978;
conditions are alginates and elastomers, either with a custom tray Applegate 1937; Applegate 1960; Hindels 1957; Leupold 1965;
or a stock tray. In tooth and tissue-supported partial dentures, a McLean 1936; Sajjan 2010; Santana-Penin 1998).
Figure 3. Final impression techniques for removable partial denture (Phoenix 2008)
Removable partial denture

How the intervention might work
Cast partial removable dental prosthesis or cast partial denture are
Complete denture based on the theory of broad stress distribution and aim to preserve
the remaining dentition (DeVan 1952; Steffel 1951). In a distal
extension partially edentulous situation, due to the compressibil-
The ultimate goal of the removable prosthesis is to maintain oral ity of the mucosa of the edentulous ridge relative to the remain-
health, function, aesthetics, comfort and psychological well-being tooth under occlusal load, a destructive class-I lever is cre-
ing of the patient (Bell 1968). To achieve these goals, an accurate ated, which tends to overload the abutment tooth (Holmes 1965;
recording of the denture foundation within functional and phys-
Leupold 1966). The various dual final impression techniques used
iologically tolerable limits is essential (Drago 2003; El-Khodary in the fabrication of cast partial denture and semiprecision attach-
1985; Massad 2005). Of the five cardinal objectives of impression, ments help reduce the transfer of excessive stress to the abutment
the two main factors that prevent the dislodgement of denture tooth during occlusal loading, thereby improving support and pre-
and increase the chewing efficiency of the denture are retention serving the health of the remaining oral tissues (Blatterfein 1980;
and stability (Boucher 1944, Friedman 1957; Jacobson 1983a; Leupold 1966). Hence, the choice of final impression technique
Jacobson 1983b). Loss of these qualities reduces comfort, masti-
and material is very pertinent in treating partially edentulous pa-
cation, speech and self esteem, leading to decreased efficiency of tients based on the individual patient’s condition and needs.
the denture and poor patient satisfaction (Silva 2014). Retention
and stability are directly related to patient adherence in wearing
the denture. Denture-related problems can be due to patient or
dentist-related factors or to processing errors (Critchlow 2011).
Why it is important to do this review
Denture complaints are mostly dentist-related due to faulty design Treatment with complete dentures or partial dentures involves
and not patient-related (Brunello 1998; Laurina 2006). The most multiple steps, some of which are crucial for its success. One such
common denture-related problems are insufficient retention and step is the final impression procedure. Retention, stability, sup-
improper jaw relations; both are directly and indirectly related to port, chewing efficiency, patient comfort and overall satisfaction
the final impression technique and the material used in the fabri- depend on the correct recording of the final impression during
cation of complete dentures (Kotkin 1985). complete denture and partial denture fabrication (Cunha 2013).
There are no evidence-based clinical practice guidelines in the fab- Removable partial denture
rication of removable dental prosthesis to inform policy makers, We will include trials with participants who are partially edentu-
healthcare providers, patients or the public at large (Owen 2006). lous and require rehabilitation with permanent removable partial
There are narrative reviews and evidence-based reviews published, denture for one or both arches. We will exclude trials treating par-
but to date, no systematic review with meta-analysis has provided ticipants with implant-supported or retained dentures, with any
evidence to support the superiority of one material or its related form of intracoronal or extracoronal attachments excluding Ak-
technique or combination over another for edentulous patients ers, and bar clasp transitional partial denture, treatment partial
(Carlsson 2013; Daou 2010; Rao 2010; Zinner 1981). denture, temporary partials, overdenture and immediate partial
denture in the study.
Types of interventions
OBJECTIVES
To assess the effects of different final impression techniques and Complete denture
materials used in the fabrication of complete dentures for reten-
We will include trials that compare the following.
tion, stability, comfort and quality of life in completely edentulous
1. The same material and different techniques.
patients.
2. The same technique with different materials.
To assess the effects of final impression techniques and materials 3. Different techniques with different materials.
used for fabrication of removable partial dentures in partially eden- Different types of techniques will be included for comparison 1
tulous patients for stability, comfort, overextension and quality of and 2.
life in partially edentulous patients. • Single stage using one-step final impression.
• Two-stage techniques using primary and final impression,
either single step or two-step.
METHODS The following interventions will be included under comparison

3.
• Different impression techniques for flabby ridge.
• Different neutral zone techniques for resorbed ridge.
Criteria for considering studies for this review • Any of the above techniques done with different materials.
Different types of final impression materials will be included in

the intervention for comparison 1, 2 and 3.
• Alginate.
Types of studies • Zinc oxide eugenol.
We will include all randomised controlled trials (RCTs) and cross- • Elastomeric impression materials.
over trials in any language. • Impression plaster.
• Green stick.
We will not consider any material that is used for border mould-
Types of participants ing to be a final impression material. We will only consider the
impression material and technique used for border moulding and
final impression as the materials and techniques in the review.
Complete denture
We will include trials treating participants who are completely Removable partial denture
edentulous and have undergone complete denture treatment in We will include trials that compare the following.
both arches, regardless of age, sex and socioeconomic status. We 1. Tooth-supported conditions, using:
will also include trials treating single complete denture partici- i) the same materials and different techniques;
pants if the outcome is reported for that particular arch only. We ii) different materials and the same technique.
will exclude trials treating participants with implant-supported or 2. Tooth-tissue-supported conditions, using:
retained prosthesis as well as overdenture and immediate denture i) the same material and different dual impression
participants. techniques;
ii) different dual impression techniques and different 3. Patient-reported preference for any technique or material,
materials. dislodgement of the denture during function
Different types of final impression material that will be included
in interventions 1 and 2 include the following.
• Alginate. Removable partial denture
• Zinc oxide eugenol. 1. Number of border and intaglio adjustments up to one
• Elastomeric impression materials. month after insertion of denture. We will not include sore spots
• Green stick. as an outcome for removable partial dentures as this may occur
• Fluid Wax. due to other components of the partial denture, such as poor
We will not consider any material that is used for border mould- design or placement of the components during fabrication, and
ing to be a final impression material. We will only consider the not always due to overextension of the borders of the denture
impression material and technique used for border moulding and 2. Number of years of service after which a reline is required
final impression as the materials and techniques in the review. 3. Abutment mobility, gingival health and denture base
adaptation assessed quantitatively by operators
Types of outcome measures

The outcome measures can be both qualitative and quantitative. Search methods for identification of studies
We will develop detailed search strategies for each database to
Primary outcomes identify relevant trials. The basis for the search strategies will be
the one we develop for MEDLINE via OVID (see Appendix
1), which we will combine with the Cochrane Highly Sensi-
Complete denture tive Search Strategy (CHSSS) for identifying randomised trials
1. Patient-reported oral health-related quality of life with any in MEDLINE: sensitivity maximising version (2008 revision) as
prevalidated questionnaire (inclusive of all domains in Oral referenced in Chapter 6.4.11.1 and detailed in box 6.4.c of the
Health Impact Profile Questionnaire OHIP/OHIP-Edent, Cochrane Handbook for Systematic Reviews of Interventions (Higgins
14,20, 49, GOHAI (Geriatric Oral Health Assessment Index)) 2011). We will link the EMBASE search to an adapted version
2. Patient-reported quality of the denture assessment by any of the Cochrane EMBASE Project filter for identifying RCTs in
prevalidated questionnaire inclusive of retention, stability, EMBASE via OVID (see http://www.cochranelibrary.com/help/
comfort, chewing ability, satisfaction and denture dislodgement central-creation-details.html for information).
during function, for one or all of the factors
Electronic searches
Removable partial denture We will search the following databases.
1. Patient-reported oral health-related quality of life with any • Cochrane Oral Health Group Trial Register (to present).
prevalidated questionnaire (inclusive of all domains in Oral • Cochrane Central Register of Controlled Trials
Health Impact Profile Questionnaire OHIP/OHIP- Edent, (CENTRAL via The Cochrane Library, current issue).
14,20, 49, GOHAI (Geriatric Oral Health Assessment Index)) • MEDLINE via OVID (1946 to present).
2. Patient-reported quality of the denture assessment by any • EMBASE via OVID (previous six months to present).
pre-validated questionnaire inclusive of stability, comfort,
chewing ability, satisfaction and denture dislodgement during Due to the Cochrane EMBASE Project to identify all clinical tri-
function, for one or all of the factors als on the database and add them to CENTRAL, we will only
search the last six months of the EMBASE database. Please see
the searching page on the Cochrane OHG website for more in-
Secondary outcomes formation. We will not impose any other restrictions on the
language or date of publication when searching the electronic
databases.
Complete denture
1. Number of border adjustments or sore spots up to one
month after insertion of denture Searching other resources
2. Denture base retention (movement), stability and We will search the following trials registries for ongoing and un-
overextension as assessed quantitatively or qualitatively by a published studies.
calibrated operator up to one month after insertion • ClinicalTrials.gov (to present).
• The WHO International Clinical Trials Registry Platform 6. Intervention: number of groups, the impression technique
(ICTRP) (to present). and materials used in the intervention and control groups. If
trialists performed face bow transfer, occlusal registration
We will screen the references of included studies to identify ad-
technique and scheme. For cross-over trials, we will record the
dtional records, and we will check review articles for studies not
period of habituation prior to cross-over.
identified by the above mentioned search strategy. When we iden-
7. Outcomes: primary and secondary outcomes and the time
tify protocols of published papers, we will contact the authors for
points at which they are assessed.
more information. If we identify non-English records, we will have
8. Others: funding source, conflict of interest.
them translated.
Assessment of risk of bias in included studies

Data collection and analysis We will assess the risk of bias of included studies for internal
validity, as per Higgins 2011, in the following domains.
1. Sequence generation (selection bias).
Selection of studies 2. Allocation sequence concealment (selection bias).
We will import all of the retrieved search results from the dif- 3. Blinding of participants and personnel (performance bias).
ferent databases to reference manager software to remove dupli- 4. Blinding of outcome assessment (detection bias).
cates. As a part of the data extraction process, two review authors 5. Incomplete outcome assessment (attrition bias).
(SJ and BPS) will independently evaluate all retrieved studies by 6. Selective outcome reporting bias (reporting bias).
cross-checking the title and abstract against the inclusion and ex- With cross-over trials, if the design is suitable for the outcome,
clusion criteria. When the title or abstract do not clearly state we will not consider the duration of washout, since Hyde 2014
the objectives, methods and results, we will retrieve the full text showed that there was no period effect or carry-over effect in a
along with additional information if required. When we identify randomised cross-over denture trial. We will accept a minimum
multiple publications of one study, we will link them under the period of one to two weeks of habituation prior to cross-over.
same author name. After initial screening, two review authors will We will grade the risk of bias as low, high or unclear based on pre-
compare their selection of included studies and come to an agree- set criteria presented in Appendix 2, conforming to the Cochrane
ment on ambiguous studies. When review authors differ, then we Handbook for Systematic Reviews of Interventions (Higgins 2011).
will consult the third and fourth authors (MPP and BR) and the We will generate a ’Risk of bias’ summary graph and figure and use
methodologist (RK) to come to a final agreement on the inclusion these judgements to grade the overall quality of evidence for each
of the study. When one of the two screening authors is an author comparison and outcome in the ’Summary of findings’ tables. We
of a retrieved study, another author will assess it for inclusion to will contact the authors if any clarification is required regarding
avoid bias. We will provide the reasons for exclusion in the ’Char- the randomisation and allocation concealment domains. If the
acteristics of excluded studies’ table. author does not respond, and the methods used are not clearly
stated in the article, we will consider that the study is at unclear
risk of bias. Two review authors (SJ and BPS) will independently
Data extraction and management assess the risk of bias of the included studies, and MPP will check
all risk of bias assessments. We will resolve any ambiguity through
We will customise a comprehensive data extraction form to the
consensus among all authors.
objectives of this review. We will pilot test the data form, extracting
and recording the following information for included studies:
1. General information: study ID, name of the review author
Measures of treatment effect
(extractor), details of the study authors, year and date, publisher,
journal and study design. Trials may assess patient and operator-reported outcomes both
2. Study eligibility: inclusion and exclusion criteria, qualitatively and quantitatively for removable prosthetic treat-
interventions/comparators, types of outcomes. ments. Whenever studies record the outcome as dichotomous data,
3. Population and setting: population description, setting, we will report the risk ratio (RR) with 95% confidence intervals
methods of recruitment of participants. (CI). When investigators report the outcome as continuous data,
4. Methods: aim of study, design, unit of allocation, date of we will use the difference in means when the outcomes are mea-
the start and end of the trial, total study duration, ethical sured on the same scale and the standardised mean difference when
approval obtained. measured on a different scale, with 95% CI.
5. Participants: total number randomised, baseline imbalance,
withdrawals and exclusion, age, sex, type of ridge, comorbidities,
Unit of analysis issues
other treatments received after intervention.
In parallel-group trials, we will consider the participants to be the We will undertake data analysis using Review Manager 5
unit for analysis. In multi-arm trials, we will combine similar arms (RevMan) following the methods stated in the Cochrane Hand-
where appropriate. If cross-over trials are analysed and reported book for Systematic Reviews of Interventions (Higgins 2011; RevMan
correctly, we will combine the paired analysis adjusted data with 2014). When there is a similarity across the participants, inter-
the results of parallel group trials using the generic inverse variance ventions and outcomes, we will perform a meta-analysis. We will
(GIV) method. To prevent a unit-of-analysis error with cross-over combine mean differences (MD) (or standardised mean differ-
trials, we will use the first period data only and consider the study ences (SMD) if studies use different scales) for continuous data,
as a parallel-group trial for analyses. and RRs for dichotomous data. Our general approach will be to
use a random-effects model. With this approach, the CIs for the
average intervention effect will be wider than those obtained using
Dealing with missing data a fixed-effect model, leading to a more conservative interpretation.
If we observe any missing data in the included studies, we will We will present data in an additional table when it is not feasible
attempt to contact the study author for clarification. If feasible we to perform a meta-analysis.
will estimate the missing data from the available results following
the methods stated in the Cochrane Handbook for Systematic Re-
Subgroup analysis and investigation of heterogeneity
views of Interventions (Higgins 2011).
For complete denture, we will perform subgroup analyses accord-
ing to the following considerations.
Assessment of heterogeneity 1. Use of a face bow transfer with semi-adjustable articulator
during the complete denture treatment.
We will analyse and investigate heterogeneity at three levels: clini-
2. Types of ridges (we will group them using American College
cal heterogeneity, methodological heterogeneity and statistical het-
of Prosthodontics (ACP) classification I and II versus III and IV
erogeneity. Clinical heterogeneity and methodological heterogene-
or Atwoods classification above order III versus below order III).
ity will be assessed for age, trial types, outcomes measured, use of
3. Performance of the intervention on a single arch or on both
face bow, follow-up, risk of bias, type or classification of the ridge
the arches, for the primary outcomes.
and other factors that may arise after the analysis. For statistical
4. Trial type, in order to understand the effect of this on the
heterogeneity, we will check the direction and magnitude of the
outcomes.
effect along with overlapping CI and point estimates. We will as-
sess statistical heterogeneity using the Chi2 statistic when the Chi
2
value is greater than the degrees of freedom (1 − d), when P
Sensitivity analysis
value is less than 0.05 and for studies with small sample size if
it is less than 0.1. We will use the I2 to quantify heterogeneity To evaluate the robustness of the pooled estimate, we will exclude
according to Higgins 2011. The I2 statistic indicates the degree of the low and unclear quality studies determined by sequence gen-
heterogeneity, and the value ranges from 0 to 100. A higher value eration and allocation concealment, and also where we used the
indicates greater heterogeneity. A rough guide for interpretation first period data only from cross-over studies. We will undertake
of the I2 is as follows: 0% to 40% might not be important; 30% sensitivity analyses for occlusal registration techniques to assess
to 60% may represent moderate heterogeneity; 50% to 90% may their effects on the outcomes.
represent substantial heterogeneity; 75% to 100% may represent
considerable heterogeneity. When I2 > 60%, we will investigate
Summary of findings table
heterogeneity using a random-effects model or explore a subgroup
analysis. When > 80% heterogeneity is present, we will not pool We will generate a ’Summary of findings’ table for comparison 1,
the data. 2 and 3, and we will consider comparison 3 (different techniques
with different materials), as critical for decision-making.
We will report the following outcomes in the ’Summary of find-
Assessment of reporting biases ings’ table.
1. Complete dentures.
If we include a sufficient number of studies (at least 10) in the
i) Patient-reported quality of life.
meta-analysis, then we will attempt to look for publication bias
ii) Patient-reported quality of the denture.
using a funnel plot, which we will assess for asymmetry as suggested
iii) Number of border adjustments and sore spots after
by Higgins 2011.
insertion of denture.
2. Partial dentures.
i) Patient-reported quality of life.
Data synthesis
ii) Patient-reported quality of the denture.
iii) Number of border and intaglio surface adjustments The authors would like to acknowledge the contribution of Anne
after insertion of denture. Littlewood (Information Specialist), Laura CI MacDonald (Man-
We will create the ’Summary of findings’ table and assess the quality aging Editor), Helen Wakeford (Deputy Managing Editor), the
of the evidence as high, moderate, low or very low in accordance Coordinating Editors (Cochrane Oral Health Group) and Prathap
with the section 11.5 of Higgins 2011 using GRADE methods and Tharyan (Director, Cochrane South Asia) for their immense con-
the GRADEPro software package (GRADE 2004; GRADEpro tribution in writing this protocol. We also thank Tanya Walsh,
2014). We will grade the body of evidence based on the risk of Philip Riley, Hugh Devlin and Paul Hyde for their comments on
bias of included studies, directness of the evidence, inconsistency the review.
between results, imprecision of measure of effects, and publication
bias. We will provide a citation and rationale for the figure we use This protocol is an output of a protocol development workshop
to calculate the assumed risk. organised by the Cochrane South Asia (funded by UKaid; Depart-
ment of International Development), CMC Vellore, India.
We would like to thank Muthu Murugan, Head and Professor of

Paedodontics, College of Dental Science, Sri Ramachandra Med-
ACKNOWLEDGEMENTS ical University, Chennai, India for his expert opinion.
REFERENCES
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Indicates the major publication for the study
APPENDICES
Appendix 1. MEDLINE (OVID) search strategy

1. exp mouth, edentulous/
2. edentulous.mp.
3. (teeth adj5 (missing or absent or absence)).mp.
4. exp Dentures/
5. (denture$ or “dental prosthes$”).mp.
6. or/1-5
7. Dental impression technique/
8. Dental casting technique/
9. ((“dental impress$” or “dental imprint”) adj5 (technique$ or technic$)).mp.
10. (“negative production” adj5 (technique$ or technic$)).mp.
11. ((denture$ or “dental prosthes$”) and (“single stage” or “two stage” or “1 stage” or “2 stage” or “one stage” or “one step” or “1 step”
or “two step” or “2 step”)).mp.
12. (mucostatic or “muco compress$” or “selective pressure” or “functional impression technique$” or “neutral zone impression$” or
“open mouth” or “closed mouth” or “border moulding” or “hand manipulat$”).mp.
13. (cast$ and (alter$ or one-piece)).mp.
14. or/7-13
15. exp Dental impression materials/
16. (alginate$ or “zinc oxide eugenol” or elastomer$ or elastomeric or plaster$).mp.
17. (“dental impress$” adj5 material$).mp.
18. (“dental imprint$” adj5 material$).mp.
19. (dental adj5 negative adj5 material$).mp.
20. or/15-19
21. 14 or 20
22. 6 and 21
This search will be combined with the Cochrane Highly Sensitive Search Strategy (CHSSS) for identifying randomized trials in
MEDLINE: sensitivity maximising version (2008 revision) as referenced in Chapter 6.4.11.1 and detailed in box 6.4.c of The Cochrane
Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011] (Higgins 2011).
1. randomized controlled trial.pt.
2. controlled clinical trial.pt.
3. randomized.ab.
4. placebo.ab.
5. drug therapy.fs.
6. randomly.ab.
7. trial.ab.
8. groups.ab.
9. or/1-8
10. exp animals/ not humans.sh.
11. 9 not 10
Appendix 2. Table 1
Risk of Bias Interpretation Within a study Across studies
Low risk of bias Plausible bias unlikely to seriously Low risk of bias for all key domains Most information is from studies
alter the results at low risk of bias
Unclear risk of bias Plausible bias that raises some Unclear risk of bias for one or more Most information is from studies
doubt about the results key domains at low or unclear risk of bias
High risk of bias Plausible bias that seriously weak- High risk of bias for one or more The proportion of information
ens confidence in the results key domains from studies at high risk of bias is
sufficient to affect the interpreta-
tion of results
CONTRIBUTIONS OF AUTHORS
Development of the idea and creating the framework for the pro- Dr Srinivasan
tocol
Writing and editing the Background Dr Srinivasan, Dr Balandra and Dr Murukan
Writing and editing the Methods Dr Srinivasan, Mr Richard, Dr Balandra
Expert opinion and editing the protocol Dr Murukan, Dr Balasubramanian
DECLARATIONS OF INTEREST
Srinivasan Jayaraman: The author is the principal investigator of a randomised controlled trial being conducted on impression techniques
in complete dentures. If those studies are eligible, other authors in the review will evaluate them for inclusion and assess the risk of
bias. The author has no financial conflict of interest as the study is self-funded.
Richard Kirubakaran: none known.
Balendra Pratap Singh: none known.
Murukan Pazhaniappan Pillai: none known.
Balasubramanian Ramanathan: none known.
SOURCES OF SUPPORT
Internal sources
• Balendra Pratap Singh, India.
The author is receiving salary, IT, library support and travel support to attend “Protocol Development Workshop” at CMC, Vellore
from King George’s Medical University, Lucknow, India.
External sources
• National Institute for Health Research (NIHR), UK.
This project was supported by the NIHR, via Cochrane Infrastructure funding to Cochrane Oral Health. The views and opinions
expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or
the Department of Health.
• Cochrane Oral Health Global Alliance, Other.
The production of our reviews is partly funded by our Global Alliance partners (http://oralhealth.cochrane.org/partnerships-
alliances): British Association for the Study of Community Dentistry, UK; British Association of Oral Surgeons, UK; British
Orthodontic Society, UK; British Society of Paediatric Dentistry, UK; British Society of Periodontology, UK; Canadian Dental
Hygienists Association, Canada; Mayo Clinic, USA; National Center for Dental Hygiene Research & Practice, USA; New York
University College of Dentistry, USA; NHS Education for Scotland (NES); and Royal College of Surgeons of Edinburgh, UK.

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Cochrane Database of Systematic Reviews

Fabrication of complete/partial dentures (different final

Jayaraman S, Singh BP, Ramanathan B, Pazhaniappan Pillai M, Kirubakaran R

Jayaraman S, Singh BP, Ramanathan B, Pazhaniappan Pillai M, Kirubakaran R.

Fabrication of complete/partial dentures (different final

Editorial group: Cochrane Oral Health Group.

BACKGROUND timated to surpass two billion by 2050 (United Nations 2013).

special or dual impression procedure is indicated due to the rel-

Removable partial denture

METHODS The following interventions will be included under comparison

Different types of final impression materials will be included in

Types of outcome measures

Assessment of risk of bias in included studies

We would like to thank Muthu Murugan, Head and Professor of

Additional references Blatterfein 1980

Freeman 1969 Hugo 2009

Slade 2014 United Nations 2013

Appendix 1. MEDLINE (OVID) search strategy

Risk of Bias Interpretation Within a study Across studies

Writing and editing the Background Dr Srinivasan, Dr Balandra and Dr Murukan

Writing and editing the Methods Dr Srinivasan, Mr Richard, Dr Balandra

Expert opinion and editing the protocol Dr Murukan, Dr Balasubramanian

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