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Quality of Life of Implant-Supported Overdenture and Conventional Complete Denture in Restoring the Edentulous Mandible: A Systematic Review Li Zhang, MDS,* Chunxiao Lyu, DDS,* Zhenzhen Shang, DDS,* Aidi Niu, DDS,* and Xing Liang, DDS, PhD† E dentulism is a dentition defect that is defined as the loss of all perma- nent teeth in the maxilla or (and) mandible.1 It has a serious impact on eating, talking, facial appearance and the quality of life (QoL). Therefore, completely edentulous patients are handicapped according to the World Health Organization’s (WHO) criteria.2 Although the prevalence of edentulism will be decreased with the improvement of oral health care, in seniors (aged 65+), the prevalence has still been estimated to be 26% in the United States, 15%–78% in Europe, and 11% in China.3 The conventional treatment for edentulism was a complete denture.4 However, for conventional complete denture (CCD) wearers, lack of stability and retention of mandibular dentures, together with residual bone resorption, and decreased chewing ability have been commoncomplaints.5The treatmentwith endosseous implants has changed these situations. This treatment significantly improves stability, retention, and chew- ing ability.6–8 A panel of experts reached a consensus at a symposium held at McGill University in 2002.9 Their state- ment is as follows: “The evidence cur- rently available suggests that the restoration of the edentulous mandible with a conventional denture is no longer the most appropriate first choice prostho- dontic treatment. There is now over- whelming evidence that a two-implant overdenture should become the first choice of treatment for the edentulous mandible.” Therefore, an increasing number of researchers have investigated the impact of implant-supported over- dentures (IODs), such as QoL and den- ture satisfaction.4,7,8,10 The definition of QoL, which can be applied to most important domains of life,11 has evolved in terms of health by the WHO.12 QoL has been used as an indicator to evaluate oral health, especially in the elderly.11,13 Oral *Graduate Student, State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China. †Professor, State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China. Reprint requests and correspondence to: Xing Liang, DDS, PhD, State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, No. 14, 3rd Section, RenMin South Road, Chengdu, Sichuan Province, China, 610041, Phone: +86-28-85502141, Fax: +86-28-85502407, E-mail: xingliangdent@vip.163.com ISSN 1056-6163/17/02606-945 Implant Dentistry Volume 26 � Number 6 Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/ID.0000000000000668 Objective: The aim of this sys- tematic review was to evaluate the oral health-related quality of life (OHRQoL) associated with an implant-supported overdenture (IOD) compared with a conventional com- plete denture (CCD) in restoring the edentulous mandible. Methods: A literature search was performed in the MEDLINE (through Ovid), PubMed, and Cochrane Library databases for articles pub- lished between 1990 and July 2016. The search was restricted to articles published in English. Two reviewers selected the articles based on the inclusion and exclusion criteria. Another 2 reviewers analyzed the data. Results: From 108 articles that were obtained, 5 articles met the inclusion criteria. Four studies had a high risk of bias, and 1 study had an unclear risk of bias. There was a sig- nificant difference in Oral Health Impact Profile (OHIP) scores between pre- and post-treatment within the groups and in posttreatment OHIP scores between IOD and CCD groups. Conclusion: Regarding the eden- tulous mandible, patients benefited more from the IOD with 2 implants, as determined by OHRQoL scores. Considering the differences between each domain of the Oral Health Impact Profile (OHIP) questionnaire and the lack of long-term perfor- mance, more random control trials with sufficient sample sizes need to be designed to investigate long-term per- formance after treatment. (Implant Dent 2017;26:945–950) Key Words: edentulism, dental implant, satisfaction of prosthesis, Oral Health Impact Profile ZHANG ET AL IMPLANT DENTISTRY / VOLUME 26, NUMBER 6 2017 945 Copyright � 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. health-related quality of life (OHR- QoL), which was introduced by Gift and Redford,14 refers to the assessment of an individual’s oral health and func- tion and emotional well-being.15 The mainmethod of investigatingOHRQoL is a questionnaire. The validity of the Oral Health Impact Profile (OHIP-49), which was first used to evaluate OHR- QoL by Slade and Spencer, has been assessed.16 The OHIP-49 consists of 49 items that cover 7 domains: func- tional limitation, physical pain, psycho- logical discomfort, physical disability, psychological disability, social disabil- ity, and handicap. The OHIP-49 has been used to evaluate the effectiveness of treatment for edentulous patients in clinical trials.4,10,17 However, as the OHIP-49 is a long questionnaire that is complex formost patients, and especially for the elderly, a shorter version of it was suggested by some researchers. The developer of the OHIP-49 introduced the first short version, the OHIP-14, and found that the latter had good reliability, validity, and precision.18 Then another short version, named the OHIP- EDENT, which was considered to be more appropriate for edentulous than the OHIP-14, was introduced by Allen and Locker.19 The OHIP-14 and the OHIP-EDENT have been widely used to evaluate the OHRQoL of edentulous patients.4,20–22 The aim of this systematic review was to evaluate the OHRQoL of IOD, measured by the OHIP-49, the OHIP- 14, and the OHIP-EDENT, compared with CCD. MATERIALS AND METHODS This systematic review was under- taken based on the Preferred Reporting Items for Systematic Reviews andMeta- Analyses (PRISMA) Guidelines.23 Search Strategy A broad literature search was per- formed for articles published between 1990 and July 2016 in the MEDLINE (through Ovid), PubMed, and Cochrane Library databases. The articles were limited to those published in English, and the search used the Medical Subject Headings (MeSH). The MeSH terms were as follows: “dental implant,” “dental implantation,” “dental prosthesis, implant-supported,” “denture, complete,” “denture, overlay,” and “quality of life.” Two reviewers (L.Z. and C.L.) independently selected the articles first through reading the titles and abstracts based on the inclusion and exclusion criteria (Table 1). If they had different ideas about an article, a third reviewer (X.L.) participated in a negotiation. Then full-text documentswere obtained from the databases mentioned above. For those that potentially met the inclu- sion criteria, including both the search results and the references, full-texts were obtained for further assessment. Article Analysis The literature characteristics, which contained subjects and study design and quantitative results, were extracted from the original articles. The assessment of the study design was based on the classification of clinical epidemiology.24 The assessment of the methodological quality of articles was undertaken by 2 reviewers (L.Z. andC.L.) independently, based on the Cochrane collaboration’s tool. The items were as follows: random sequence generation, allocation conceal- ment, blinding of participants and per- sonnel, blinding of outcome assessors, incomplete outcome data, and selective reporting. If any of these items was con- sidered to be “high risk” or “unclear risk,” the study was assessed as “high risk of bias” or “unclear risk of bias”correspondingly. Only when all the items were estimated as “low risk” was the study evaluated as “low risk of bias.” In the case of differences, a third reviewer was consulted. Data Extraction From the included articles, the re- viewers extracted the following data: authors, country, year of publication, study design, sample size, follow-up period (months), study description, type of measurement instrument, baseline, and posttreatment total scores. Datawere extracted by 2 reviewers independently. When there was disagreement, a third reviewer provided an opinion. RESULTS Search Results Of 108 articles identified from the search, 88 were excluded after prelimi- nary assessment through titles and ab- stracts. After the reviewers read the remaining 20 full-text documents, 15 studies were excluded for the following reasons: 1 article was a systematic review, 1 article was a review article, 2 articles did not have the total scores, 4 articles had no baseline or posttreatment scores, 3 studies had a design that only Table 1. Inclusion and Exclusion Criteria Inclusion criteria RCT or control clinical trial (CCT) Study for mandibular edentulism 2 implants for overdenture OHIP used to assess OHRQoL OHIP total scores were available Both baseline and posttreatment scores involved Published in English Exclusion criteria Retrospective study, case report, systematic review, and literature review Study contained maxillary edentulism 1 implant for overdenture or more than 2 implants for overdenture Other methods of measurement for OHRQoL OHIP total scores could not be available Baseline scores not reported Implants loaded immediately No control group: only comparing pretreatment (CCD) with postreatment (IOD) This study reviewed the ones which investigated the OHRQoL, assessed by Oral Health Impact Profile (OHIP) questionnaire, between IOD and CCDs. Fig. 1. Flowchart of selective progress. Five articles met the inclusion criteria and were thus selected for inclusion in this review ac- cording to the PRISMA guidelines. 946 QUALITY OF LIFE OF IOD VS CCD ZHANG ET AL Copyright � 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. converted CCD to ICD without group- ing, 2 articles had an unclear number of implants, 1 article was a commentary article, and 1 article did not report both groups’ scores. Figure 1 presents the flowchart of the progress of selection fol- lowing the PRISMA Guidelines. Characteristics of Included Articles The 5 included studies were all random control trials (RCTs). In total, 334 participants were involved, of which 34 participants were elders who were older than 75 years and who needed help for activities of life. One study reported the outcome measured by the OHIP-49. Three studies evalu- ated OHRQoL using the 20-item ques- tionnaire (OHIP-EDENT). One study used theOHIP-14 to evaluateOHRQoL (Table 2). Quality of Studies Included Risk of bias assessment (Table 3) showed that no study had low risk of bias, 4 studies10,25–27 had a high risk of bias, and 1 study22 had an unclear risk of bias. OHRQoL of Implanted-Supported Overdenture and Conventional Complete Denture Table 4 shows the included study data, which consisted of baseline and posttreatment scores of CCD and IOD. Muller et al25 evaluated the outcomes through the interaction term (time 3 treatment) between the IOD and CCD groups. Cakir et al27 assessed the data through pre- and post-treatment score differences. The rest of the stud- ies10,22,26 evaluated the group’s differ- ences through posttreatment scores directly. All the studies showed that IOD had a significant effect on improving the edentulous individuals’ QoL. DISCUSSION For the studies that compared the impact on edentulous individuals’ OHRQoL of IODs versus CCDs, it was necessary to explain the treatment progress to the patients and ask them whether they were willing to participate in the trials or not; moreover, the re- searchers would know the allocation of the group in the course of the trials, so a blind method was not possible, and the risk of bias would be high. How- ever, because of the obvious differences between IOD and CCD, a nonblind method was inevitable. Table 2. Characteristics of Studies Included Study Study Design Follow- up, mo No. of Participants Study Description Outcome Reported Awad et al10 Canada RCT 2 102 Evaluation of OHRQoL of IOD vs CCD (re-fabricated) for those who had 10-y edentulous history OHIP-49 Heydecke et al22 Canada RCT 6 60 Assessment of OHRQoL and general health-related quality of life (HRQoL) of IOD vs CCD (re-fabricated) for elders, aged 65–75 y, who had 5-y edentulous history OHOP- EDENT SF-36 Muller et al25 Switzerland RCT 12 34 Evaluation of OHRQoL and denture satisfaction of IOD vs CCD (relined) for elders who were older than 75 years and needed help for activities of daily life OHIP- EDENT DS-VAS Gjengedal et al26 Norway RCT 24 54 Evaluation of OHRQoL and HRQoL of IOD vs CCD (relined) for those who were younger than 76 years OHIP- EDENT SF-36 Cakir et al27 Turkey RCT 12 58 Four groups compared OHRQoL and HRQoL of implanted-supported denture vs removable denture: Group1(IOD); Group2(implant- supported fixed partial denture); Group3(CCD); Group4(removable partial denture) OHIP-14 SF-36 Some researchers re-fabricated the participants’ denture, whereas other researchers only relined the individuals’ previous denture. The researchers also investigated the patient satisfaction measured by SF-36 or DS-VAS besides OHRQoL evaluated by OHIP. Table 3. Risk of Bias Based on the Cochrane collaboration’s Tool Study Random Sequence Generation (Selection Bias) Allocation Concealment (Selection Bias) Blinding of Participants and Personnel (Performance Bias) Blinding of Outcome Assessment (detection bias) Incomplete Outcome Data (Attrition Bias) Selective Reporting (Reporting Bias) Award et al10 Low risk Unclear High risk High risk Low risk Low risk Heydecke et al22 Low risk Low risk High risk Low risk Low risk Low risk Muller et al25 Low risk Low risk High risk Unclear Low risk Low risk Gjengedal et al26 Low risk Low risk High risk Unclear Low risk Low risk Cakir et al27 Low risk Unclear High risk Unclear Low risk Low risk If any of these items were considered to be “high risk” or “unclear risk,” the study would be assessed as “high risk of bias” or “unclear risk of bias” correspondingly. Only when all of the items were estimated as “low risk” would the study be evaluated as “low risk of bias.” ZHANG ET AL IMPLANT DENTISTRY / VOLUME 26, NUMBER 6 2017 947 Copyright � 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. When evaluating the rehabilitation of the elders’ edentulism, several as- pects should be considered, such as diet, esthetics, and degree of comfort. OHR- QoL could provide some explanations for those problems.14 Therefore, it was applied in the studies that compared edentulous individuals’ OHRQoL of IODs versus CCDs. The OHIP ques- tionnaire was a valid tool for evaluating OHRQoL. The studies included in this systematic review showed that the OHRQoL of the IOD group was better than the CCD group (the OHIP scores of the IOD group was lower than that of CCD group) using different OHIP questionnaires. This could broadly explain that they (OHIP-49, OHIP- EDENT, OHIP-14) had similar reliabil- ity and validity.18,19 Although the IOD’s OHIP total scores were lower than the CCD’s, and therewasa significant differencebetween the IOD group and CCD group, not all of the scores of each domain had a signifi- cant difference. In the study byHeydecke et al,22 there were 3 domains that did not show a significant difference between the IOD group and CCD group. In the study of Gjengedal et al,26 there were only 3 domains that had a significant difference between the IOD group and CCD group. Other control trials showed similar out- comes when comparing the scores of each domain.28,29 That might be due to aninsufficient sample size. It also noted that further studies should focus on those domains in which improvement was not obvious in the IOD group comparedwith the CCD group. These studies showed that the differ- ence was significant between the CCD group and IOD group in the short-term. Meanwhile, 2 studies25,26 showed that the difference after 24 months was signifi- cant, and the difference in the interaction term after 12 months was significant in Muller’s study,25 with the approximate posttreatment OHIP scores using the same questionnaire (OHIP-EDENT). However, there were different conclu- sions reported by 2 systematic re- views.30,31 Maybe these different conclusionswerecausedby improvement in the adaptability of the denture and (or) the change of the oral condition and (or) because of the cultural difference.30,32 Therefore, more longer-term RCTs with lower risk of bias need to be designed to solve the discrepancies. It has been shown that IOD was better than CCD at improving the eden- tulous patients’ OHRQoL in the studies included in this systematic review and in other control trials and crossover tri- als.29,33–35 Therefore, some researchers have proposed that IOD should be the first choice for rehabilitating the edentu- lism.9,36 Another topic is the number of implants. Some experts have stated that IOD with 2 implants was the standard option. Therefore, in this systematic review, we selected the studies using a 2-implant–supported mandibular over- denture. However, considering the qual- ity andmass of alveolar bone, the number of implants varied in some studies.37,38 Some studies that evaluated an over- denture supported by 2 or 4 implants showed that there was no significant dif- ference.39–42 In addition, cost must be taken into consideration. Hence, an overdenture supported by 2 implants should be offered first. CONCLUSION For an edentulous mandible, pa- tients benefited more from an IOD with 2 implants, as assessed by the OHR- QoL. Considering the difference in each domain of the Oral Health Impact Profile (OHIP) questionnaire and the lack of long-term performance, more RCTs with sufficient sample sizes need to be designed to investigate long-term performance after treatment. DISCLOSURE The authors claim to have no financial interest, either directly or indirectly, in the products or informa- tion listed in the article. APPROVAL Not required-the study did not involve human subjects. ROLES/CONTRIBUTIONS BY AUTHORS L.Zhang andC. Lyu:Designed this study; Z. Shang and A. Niu: Searched the literature; L. Zhang and C. Lyu: T ab le 4. O H IP S co re s of B as el in e an d P os ttr ea tm en t of C C D an d IO D st ud y C C D IO D n B as el in e M ea n 6 S D P os t M ea n 6 S D n B as el in e M ea n 6 S D P os t M ea n 6 S D A w ar d et al 1 0 (*† ) 48 98 .7 6 38 .1 89 .3 6 40 .4 2 (2 m ) 54 10 0. 6 6 37 .3 66 .1 6 28 .0 8 H ey de ck e et al 2 2 (*† ) 30 56 .3 2 6 19 .8 5 47 .8 4 6 22 .6 6 (6 m ) 30 53 .5 0 6 16 .9 4 35 .0 0 6 15 .9 4 M ul le r et al 2 5 (*‡ ) 18 32 .9 6 20 .8 4 25 .9 6 13 .4 6 (3 m ) 23 .4 4 6 13 .8 2 (1 2 m ) 16 41 .1 6 20 .3 1 20 .9 6 16 .7 4 21 .9 6 22 .0 6 G je ng ed al et al 2 6 (*† ) 26 57 .9 6 16 .8 54 .1 6 21 .9 (3 m ) 57 .3 6 24 .7 (2 4 m ) 28 66 .1 6 22 .7 35 .8 6 11 .4 35 .6 6 12 .3 C ak ir et al 2 7 (*§ ) 29 21 .2 4 6 2. 82 12 .2 4 6 2. 80 (1 2 m ) 29 18 .7 0 6 2. 52 3. 03 6 1. 45 *S ig ni fi ca nt di ffe re nc e be tw ee n pr e- an d po st -t re at m en t O H IP sc or es w ith in tr ea tm en t gr ou p. † S ig ni fi ca nt di ffe re nc e be tw ee n C C D an d IO D gr ou p, po st tr ea tm en t O H IP sc or es . ‡ S ig ni fi ca nt in te ra ct io n te rm (ti m e 3 tr ea tm en t). §S ig ni fi ca nt di ffe re nc e of pr e- an d po st -t re at m en t O H IP sc or es be tw ee n C C D an d IO D gr ou p. m in di ca te s m on th s. 948 QUALITY OF LIFE OF IOD VS CCD ZHANG ET AL Copyright � 2017 Wolters Kluwer Health, Inc. 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