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Interventions for missing teeth: Removable prostheses for the edentulous mandible (Protocol)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Interventions for missing teeth: Removable prostheses for the edentulous mandible (Protocol) i
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]
1 Department of Prosthodontics, College of Dentistry, New York University, New York, USA. 2 University Dental Hospital of Manchester,
Manchester, UK
Contact address: Leila Jahangiri, Department of Prosthodontics, College of Dentistry, New York University, 345 East 24th Street,
Room 415-S, New York, 10010, USA. lj14@nyu.edu.
Citation: Jahangiri L, Choi M, Moghadam M, Jawad S. Interventions for missing teeth: Removable prostheses for the edentulous
mandible. Cochrane Database of Systematic Reviews 2015, Issue 2. Art. No.: CD011544. DOI: 10.1002/14651858.CD011544.
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To assess the effects of no treatment, treatment with conventional removable complete denture, and treatment with implant-retained
removable prosthesis for the rehabilitation of edentulous mandibles.
Once teeth are extracted or lost, the jaw bones undergo degenera-
BACKGROUND
tive changes in size and shape that continue for the duration of the
individual’s life. This irreversible chronic disease is a phenomenon
well recognised as a pathological process (Atwood 1971) and is
termed residual ridge resorption or remodelling. This resorption
Description of the condition
can lead to a poor foundation for complete denture prostheses.
Edentulism is a state of having no teeth at all (Glossary of Edentulous mandibles (lower jaws) are particularly significant as
Prosthodontic Terms 2005), and is considered by the World the horseshoe-shaped remaining bone (residual ridge) has a smaller
Health Organization (WHO) to be a disability (WHO 2014). It surface area when compared to the maxilla (upper jaw), which re-
may result from not developing teeth in the first instance (true lies heavily on the surface area of the palate to establish a periph-
or total anodontia), but this condition is exceedingly rare. More eral seal and thus retain a complete denture. The mandibular den-
commonly, edentulism is the result of permanent tooth extrac- ture is hampered by the presence of the moving tongue and orofa-
tion in adulthood, which may or may not be due to caries, pe- cial muscles which tend to dislodge the denture during function.
riodontal disease, trauma or other orofacial pathology (e.g. cysts, Furthermore, over time the mandibular residual ridge continues
tumours). As tooth loss increases with age, older adults (over 65) to resorb (Tallgren 1972), and is affected four times more signif-
are more prone to edentulism than younger adults, with propor- icantly than the maxillary arch (Landa 1967), resulting in even
tionately higher prevalences in subsequent decades (Steele 2009). more potential difficulty in wearing lower dentures. In fact, the
This means that this condition exists most frequently in a poten- most common complaint of patients wearing complete dentures
tially vulnerable group with complex needs (Muller 2014).
Interventions for missing teeth: Removable prostheses for the edentulous mandible (Protocol) 1
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
is related to lack of retention of the mandibular prosthesis. This live to an older age. Edentulism is also linked to poorer general
resorption has been classified in different ways. The Atwood/Ca- health (Douglass 2002; Felton 2009). Therefore, management of
wood and Howell classifications (Atwood 1963; Cawood 1988) the edentulous patient has become a public health concern (Polzer
represent a scale of I-VI, with class I representing a mandible with 2010).
a tooth in place and optimum bone support, progressing to class
V and VI, where the bone has resorbed significantly. The Amer-
ican College of Prosthodontists (ACP) (McGarry 1999) classifies Description of the intervention
the status of edentulous arches with a rating of 1, 2, 3, or 4 (1
being simplest to treat and 4 being the most complex), based on Edentulous patients can be left untreated, or treated in several
the alveolar bone height, bone shape, types of overlying gingival ways: with provision of complete dentures; with implant-retained
tissues, jaw relationships, need for adjunctive surgical procedures, prostheses; or with implant-supported prostheses.
amount of available space between the lower and upper jaws, and For centuries, complete denture prostheses have been considered
other underlying systemic and psychosocial conditions of patients. the first-line of treatment for edentulism, providing the individual
For instance, lower jaws with 10 mm or less of vertical bone height with prosthetic teeth to enable mastication (chewing), optimise
with an unfavourable shallow floor of the mouth are considered speech, and restore aesthetics. In most cases, edentulous patients
to belong in the least favourable category, class 4. These cases (Ca- are provided with complete dentures alone, which the majority
wood and Howell VI, ACP 4) are anatomically least likely to be have tolerated to varying degrees. These are defined as artificial
able to tolerate a lower denture. prostheses which “substitute for missing natural teeth and soft tis-
Confounding these factors is the patient’s relative ability to adapt to sues” (Glossary of Prosthodontic Terms 2005), held in place by ad-
a prosthesis, which has been shown to decrease with age (Carlsson hesion and cohesion on supporting tissues. In some cases, prepros-
2010), be influenced by psychological (Eitner 2006) and cultural thetic surgery to optimise the denture-bearing area has been ad-
factors (Scott 2001), and is irrespective of the perceived quality of vocated, but a Cochrane review has found weak evidence that the
the prosthesis (Garrett 1996; Heydecke 2003). As a result, many provision of dental implants are preferable (Coulthard 2002). Na-
edentulous patients lack comfort with their prostheses, resulting tional (Thomason 2009) and international consensus statements
in an impaired ability to chew. This affects their nutritional intake, (Feine 2002) have suggested that the provision of two dental im-
which, in turn, affects their general health (Oral Health in America plants in the mandible (to retain a removable overdenture), should
2000). be the first choice of treatment due to the recognised improve-
Edentulism has been linked to systemic conditions such as car- ments in quality of life of this intervention. Furthermore a stan-
diovascular disease (Dietrich 2008; Joshipura 1996), stroke (Elter dard of care for the optimal treatment of the edentulous mandible
2003), cancer (Divaris 2010; Guha 2007), and mortality (Abnet has been proposed in the USA (Das 2012). However, this inter-
2005). The social behaviour of the edentulous population is also vention has yet to be analysed in a structured systematic review,
altered as the confidence and ability to eat with others is affected. and has not been compared to possible alternatives, such as a con-
The quality of life of many patients in this vulnerable ageing pop- ventional complete denture or no treatment. Further, there are
ulation is compromised. Edentulism is a global phenomenon, and differing opinions on the number of implants necessary and the
there is wide variation in prevalence, both between countries and types of attachments to removable prostheses.
within them. In the USA, Canada, Australia, and the United King-
dom, the prevalence of edentulism in the general population is
around 6% to 8% (Dye 2012; Emami 2013; Sanders 2004; Steele How the intervention might work
2009; Wu 2012), rising to 20% to 26% in the over 65 year-old
Dental implants work by integrating with the surrounding bone,
age group. The prevalence of edentulism in India, Mexico, Russia,
forming anchors to which removable or fixed prostheses can at-
China, Ghana, and South Africa is reported to be 11.7% (Peltzer
tach. Since the 1960s, use of dental implants has been recognised
2014). However, in lower- and middle-income countries, parts
as a method for rehabilitating the mouth following loss of teeth
of rural India, Brazil, and Turkey for example, the rate can be
(Branemark 1983). The implant itself replaces the lost tooth root.
as high as 48% to 60% of the elderly population (Emami 2013;
Overlying structures attach to the implant(s) and are termed the
Hugo 2007; Kaira 2014). However, these studies are on relatively
’prosthetic components’. These components can be connected to
small samples and more studies are required in these regions to
the implant in a manner in which the prosthesis cannot be removed
decipher the true rate and reasons for such wide variation. So-
by the patient: fixed implant-supported prosthesis. However, the
cioeconomic factors have been shown to be associated with varia-
prosthetic components can also be connected to the implant with
tions in the prevalence of edentulism, with one Canadian study re-
attachment mechanisms that allow insertion and removal by the
porting a six-fold increase in edentulism in poorer cohorts (Miller
patient: implant-retained prosthesis (Glossary of Prosthodontic
2005). With the average life expectancies increasing globally, the
Terms 2005). This review will only focus on the latter - the im-
burden of edentulism is increasing, as those who are edentulous
plant-retained (removable) mandibular prosthesis.
Interventions for missing teeth: Removable prostheses for the edentulous mandible (Protocol) 2
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Why it is important to do this review Types of interventions
It is important to do this review to compare treatment meth- We will include the following types of interventions.
ods for the management of the edentulous mandible. Edentulous • No treatment.
mandibles are considered debilitating and therefore effective re-
• Treatment with conventional removable prosthesis
habilitation using current evidence is indicated. Edentulous indi-
(complete denture) (Glossary of Prosthodontic Terms 2005).
viduals have the choice of no prosthesis, a conventional remov-
able prosthesis, an implant-retained removable prosthesis or an • Treatment with implant-retained removable prosthesis
implant-supported fixed prosthesis. There are risks and benefits to (complete overdenture) secured by one or more dental implants
each treatment modality, but these have not been formally anal- (Glossary of Prosthodontic Terms 2005.
ysed through a Cochrane systematic review. There may be varia-
tions in optimal treatments depending on patient age, extent of
ridge resorption, and the condition of the opposing arch (edentu- Types of outcome measures
lous/dentate maxilla).
Optimal treatment of the edentulous mandible is a topic of great
clinical importance for dental practitioners. The review authors Primary outcomes
have extensive experience in the implementation of related treat-
• Oral health-related and general quality of life
ment protocols in the clinical setting, and are able to promote
(encompassing but not exclusive to: patient satisfaction/comfort,
translation of the findings of this systematic review into dental
appearance, maintainability (hygiene) - as measured by validated
education, and ultimately the practice of dentistry.
questionnaires).
Secondary outcomes
• Function/chewing ability (as measured by questionnaires or
OBJECTIVES objective means, e.g. chewing tests).
• Diet/nutrition (as measured by biochemical markers, body
To assess the effects of no treatment, treatment with conven-
mass index (BMI), validated questionnaires).
tional removable complete denture, and treatment with implant-
• Prosthetic complications (as measured by frequency of
retained removable prosthesis for the rehabilitation of edentulous
prosthesis or prosthetic tooth fracture, prosthesis-induced
mandibles.
oromucosal conditions, prosthesis-induced ridge resorption).
• Implant-related complications (as measured by frequency of
peri- or post-implant placement complications, e.g. mandibular
METHODS fracture, nerve damage, haemorrhage, implant failure, peri-
implantitis).
• Cost-effectiveness (as measured by adjusted quality of life
years (QALYs) or disability adjusted life years (DALYs) or other
Criteria for considering studies for this review appropriate measure).
• Maintenance (as measured by frequency of prosthodontic
maintenance and/or patient satisfaction and quality of life
questionnaires).
Types of studies
We will consider all outcome measures in the short-term (less than
Randomised controlled trials (RCTs) investigating no treatment, one year), medium-term (one to five years), and long-term (more
treatment with a conventional removable complete denture, and than five years).
treatment with an implant-retained removable prosthesis for the
rehabilitation of edentulous mandibles. Because of the nature of
the intervention, cross-over designs and split-mouth studies are
Search methods for identification of studies
inappropriate and we will exclude such studies.
For the identification of studies included or considered for this
review, we will develop detailed search strategies for each database.
These will be based on the search strategy developed for MED-
Types of participants
LINE (OVID) (see Appendix 1) but revised appropriately for each
Participants with edentulous mandibles (adults and children). database. We will combine this search strategy with the Cochrane
Interventions for missing teeth: Removable prostheses for the edentulous mandible (Protocol) 3
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Highly Sensitive Search Strategy for identifying randomised tri- criteria, the review authors will obtain and independently assess
als in MEDLINE: sensitivity maximising version as referenced in the full report. We will contact authors if clarification is needed
Chapter 6.4.11.1 and detailed in box 6.4.c of the Cochrane Hand- on the conduct of the studies. We will link multiple reports of the
book for Systematic Reviews of Interventions (Higgins 2011). We same study under one study name. We will further refine litera-
will link the search of EMBASE to the Cochrane Oral Health ture after the initial data extraction. Any inclusion ambiguity will
Group filter for identifying RCTs. be discussed between members of the review. If consensus cannot
be reached, we will consult the Cochrane Oral Health Group to
achieve consensus. We will provide the rationale for exclusion in
Electronic searches the Characteristics of excluded studies table. A PRISMA study
We will search the following electronic databases. flow chart will be created to summarise this process.
• The Cochrane Oral Health Group’s Trials Register (to
present).
Data extraction and management
• The Cochrane Central Register of Controlled Trials
(CENTRAL, latest issue). All review authors will be involved in data extraction. At least two
• MEDLINE via OVID (1946 to present) (see Appendix 1). review authors will independently, and in duplicate, evaluate each
• EMBASE via OVID (1980 to present). study using the data extraction form that has been piloted on a
small number of studies. We will contact authors where clarifica-
We will not impose any restrictions on date of publication when tion is needed on the conduct of the studies. We will link multiple
searching the electronic databases. reports of the same study under one study name. For each study
with more than one control or comparison group for the inter-
vention, we will extract the results for each intervention arm.
Searching other resources
We will record the following information for each of the included
studies.
• Year of publication, country of origin, study design,
Unpublished trials
number of centres.
We will search the following databases for ongoing trials. • Details of participants (demographic characteristics),
• US National Institutes of Health Trials Register (http:// inclusion and exclusion criteria, any relevant health information.
clinicaltrials.gov). • Details of the type of intervention and comparison.
• The WHO Clinical Trials Registry Platform (http:// • Details of outcomes reported, including method and time
apps.who.int/trialsearch/default.aspx). of assessment, as well as adverse effects.
We will screen the bibliographies of included papers, and check
relevant review articles for studies not identified by the search Assessment of risk of bias in included studies
strategies above.
At least two review authors will assess the risk of bias in included
studies using The Cochrane Collaboration’s tool for assessing risk
Language of bias based on the Cochrane Handbook for Systematic Reviews
We will not apply any language restrictions in the electronic of Interventions (Higgins 2011). Authors will assess bias indepen-
searches. Any non-English trials that we identify will be translated dently. Where authors disagree about the risk of bias in different
through The Cochrane Collaboration. studies, disagreements will be resolved by discussion and subse-
quent majority opinion.
The domains that we will assess for each included study will be:
1. sequence generation (selection bias);
Data collection and analysis 2. allocation concealment (selection bias);
3. blinding of participants and personnel (performance bias);
4. blinding of outcome assessment (detection bias);
Selection of studies 5. completeness of outcome data (attrition bias);
We will independently identify titles and abstracts of studies meet- 6. selective outcome reporting (reporting bias); and
ing the criteria from initial electronic sources to determine any po- 7. risk of other potential sources of bias (other bias).
tentially eligible studies. All authors will be involved in the screen- The Cochrane Collaboration’s tool for assessing risk of bias is a
ing procedure. We will carry out a full text evaluation on the stud- two-part tool, the first part describing what happened in the re-
ies that fulfil the inclusion criteria to determine if we will include view, and the second part a judgement on the risk of bias based
or exclude them. When there is insufficient detail in the study ti- on the description. For example, in the case of allocation conceal-
tle and abstract to determine whether a study fulfils the inclusion ment, the reviewer criteria for assessing risk of bias will be:
Interventions for missing teeth: Removable prostheses for the edentulous mandible (Protocol) 4
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
1. low risk of bias (adequate concealment of the allocation outlined in the Cochrane Handbook for Systematic Reviews of Inter-
(e.g. sequentially numbered, sealed, opaque envelopes or ventions to estimate missing standard deviations (Higgins 2011).
centralised or pharmacy-controlled randomisation);
2. unclear risk of bias (unclear about whether the allocation
was adequately concealed (e.g. where the method of concealment Assessment of heterogeneity
is not described or not described in sufficient detail to allow a If it is appropriate that meta-analyses will be performed, we will
definite judgement)); and assess the possible presence of heterogeneity visually by inspecting
3. high risk of bias (inadequate allocation concealment (e.g. the point estimates and CIs on the forest plots; if the CIs have
open, random number lists or quasi-randomisation such as poor overlap then we will consider heterogeneity to be present. We
alternate days, date of birth, or case record number). will also assess heterogeneity statistically using a Chi2 test, where
We will tabulate a description of all of the above seven domains for a P value < 0.1 will indicate statistically significant heterogeneity.
each included trial, along with a judgement of the risk of bias (low, Furthermore, we will quantify heterogeneity using the I2 statistic.
high or unclear). We will provide a summary assessment of the A guide to interpretation of the I2 statistic as per Section 9.5.2 of
risk of bias for the primary outcome across the studies (Higgins the Cochrane Handbook for Systematic Reviews of Interventions is as
2011). For each study, we will assess according to the following follows (Higgins 2011).
rationale. • 0% to 40%: might not be important.
1. Low risk of bias, when there is a low risk of bias across all • 30% to 60%: may represent moderate heterogeneity.
seven key domains. • 50% to 90%: may represent substantial heterogeneity.
2. Unclear risk of bias, when there is an unclear risk of bias in • 75% to 100%: considerable heterogeneity.
one or more of the seven key domains.
3. High risk of bias, when there is a high risk of bias in one or
more of the seven key domains. Assessment of reporting biases
We will summarise the risk of bias in the review and present it
in tabulated form and graphically. We will take into account the If there are a sufficient number of trials (more than 10) included
number of studies with high risk of bias in the interpretation of in any meta-analysis, we will assess publication bias according
results. If a large number of studies are considered at high risk of to the recommendations on testing for funnel plot asymmetry
bias, we will employ a narrative description of results. as described in the Cochrane Handbook for Systematic Reviews of
Interventions (Higgins 2011).
Interventions for missing teeth: Removable prostheses for the edentulous mandible (Protocol) 5
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Presentation of main results included studies, the directness of the evidence, the inconsistency
We will generate a ’Summary of findings’ table for each compar- of the results, the precision of the estimates, and the risk of publi-
ison and for the important outcomes in accordance with section cation bias. We will categorise the quality of each body of evidence
11.5 of the Cochrane Handbook for Systematic Reviews of Interven- as high, moderate, low, or very low.
tions (Higgins 2011) using the GRADE methods (GRADE 2004)
and the GRADEPro software package (GRADEpro 2008). The
outcomes we will include are: Prosthetic/implant complications,
quality of life, chewing ability, diet/nutrition, and cost-effective-
ACKNOWLEDGEMENTS
ness.
We will assess the quality of the body of evidence for each com- Dr. Ivy Peltz, Department of Cariology and Comprehensive Care,
parison and outcome by considering the overall risk of bias of the New York University College of Dentistry, New York, NY USA
REFERENCES
Interventions for missing teeth: Removable prostheses for the edentulous mandible (Protocol) 7
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Health Survey 2009. http://www.hscic.gov.uk/catalogue/ edentulous patients - the York Consensus Statement. British
PUB01086/adul-dent-heal-surv-summ-them-exec-2009- Dental Journal 2009;207(4):185–6.
rep2.pdf 2010. WHO 2014
Tallgren 1972 World Health Organization. International Classification of
Tallgren A. The continuing reduction of the residual alveolar Functioning: Disability and Health (ICF). www.who.int/
ridges in complete denture wearers: a mixed-longitudinal classifications/icf/en/ 2014.
study covering 25 years. Journal of Prosthetic Dentistry 1972; Wu 2012
27(2):120–32. [PUBMED: 4500507] Wu B, Liang J, Plassman BL, Remle C, Luo X. Edentulism
Thomason 2009 trends among middle-aged and older adults in the United
Thomason JM, Feine J, Exley C, Moynihan P, Mueller States: comparison of five racial/ethnic groups. Community
F, Naert I, et al. Mandibular two implant-supported Dentistry and Oral Epidemiology 2012;40:145–53.
overdentures as the first choice standard of care for ∗
Indicates the major publication for the study
APPENDICES
Interventions for missing teeth: Removable prostheses for the edentulous mandible (Protocol) 8
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
CONTRIBUTIONS OF AUTHORS
All authors have contributed to the development of this protocol.
DECLARATIONS OF INTEREST
Leila Jahangiri: none known
Mijin Choi: none known
Marjan Moghadam: none known
Sarra Jawad: none known
SOURCES OF SUPPORT
Internal sources
• No sources of support supplied
External sources
• National Institute for Health Research (NIHR), UK.
The NIHR is the largest single funder of the Cochrane Oral Health Group
Disclaimer:
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS or the
Department of Health
• Cochrane Oral Health Group Global Alliance, Other.
The production of all our reviews is assisted by funding from our Global Alliance partners (http://ohg.cochrane.org/): 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;
and Royal College of Surgeons of Edinburgh, UK
Interventions for missing teeth: Removable prostheses for the edentulous mandible (Protocol) 9
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.