The patient general satisfaction of mandibular single-implant overdentures and conventional complete dentures: Study protocol for a randomized crossover trial. 2018

Manabu Kanazawa, and Mariko Tanoue, and Anna Miyayasu, and Shin Takeshita, and Daisuke Sato, and Mari Asami, and Thuy Vo Lam, and Khaing Myat Thu, and Ken Oda, and Yuriko Komagamine, and Shunsuke Minakuchi, and Jocelyne Feine
Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University Implant Center, Showa University Dental Hospital, Tokyo, Japan Oral Health and Society Division, Faculty of Dentistry, McGill University, Quebec, Canada.

BACKGROUND Mandibular overdentures retained by a single implant placed in the midline of edentulous mandible have been reported to be more comfortable and function better than complete dentures. Although single-implant overdentures are still more costly than conventional complete dentures, there are a few studies which investigated whether mandibular single-implant overdentures are superior to complete dentures when patient general satisfaction is compared. The aim of this study is to assess patient general satisfaction with mandibular single-implant overdentures and complete dentures. METHODS This study is a randomized crossover trial to compare mandibular single-implant overdentures and complete dentures in edentulous individuals. Participant recruitment is ongoing at the time of this submission. Twenty-two participants will be recruited. New mandibular complete dentures will be fabricated. A single implant will be placed in the midline of the edentulous mandible. The mucosal surface of the complete denture around the implant will be relieved for 3 months. The participants will then be randomly allocated into 2 groups according to the order of the interventions; group 1 will receive single-implant overdentures first and will wear them for 2 months, followed by complete dentures for 2 months. Group 2 will receive the same treatments in a reverse order. After experiencing the 2 interventions, the participants will choose one of the mandibular prostheses, and yearly follow-up visits are planned for 5 years. The primary outcome of this trial is patient ratings of general satisfaction on 100 mm visual analog scales. Assessments of the prostheses and oral health-related quality of life will also be recorded as patient-reported outcomes. The secondary outcomes are cost and time for treatment. Masticatory efficiency and cognitive capacity will also be recorded. Furthermore, qualitative research will be performed to investigate the factors associated with success of these mandibular denture types. Clinical outcomes, such as implant survival rate, marginal bone loss, and prosthodontic complications, will also be recorded. CONCLUSIONS The results of this randomized crossover trial will clarify whether mandibular single implants and overdentures for edentulous individuals provide better patient general satisfaction when compared to conventional complete dentures. BACKGROUND This clinical trial was registered at the University Hospital Medical Information Network (UMIN) Center (UMIN000017883).

UI MeSH Term Description Entries
D007575 Jaw, Edentulous The total absence of teeth from either the mandible or the maxilla, but not both. Total absence of teeth from both is MOUTH, EDENTULOUS. Partial absence of teeth in either is JAW, EDENTULOUS, PARTIALLY. Edentulous Jaw,Edentulous Jaws,Jaws, Edentulous
D008334 Mandible The largest and strongest bone of the FACE constituting the lower jaw. It supports the lower teeth. Mylohyoid Groove,Mylohyoid Ridge,Groove, Mylohyoid,Grooves, Mylohyoid,Mandibles,Mylohyoid Grooves,Mylohyoid Ridges,Ridge, Mylohyoid,Ridges, Mylohyoid
D011788 Quality of Life A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D012107 Research Design A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly. Experimental Design,Data Adjustment,Data Reporting,Design, Experimental,Designs, Experimental,Error Sources,Experimental Designs,Matched Groups,Methodology, Research,Problem Formulation,Research Methodology,Research Proposal,Research Strategy,Research Technics,Research Techniques,Scoring Methods,Adjustment, Data,Adjustments, Data,Data Adjustments,Design, Research,Designs, Research,Error Source,Formulation, Problem,Formulations, Problem,Group, Matched,Groups, Matched,Matched Group,Method, Scoring,Methods, Scoring,Problem Formulations,Proposal, Research,Proposals, Research,Reporting, Data,Research Designs,Research Proposals,Research Strategies,Research Technic,Research Technique,Scoring Method,Source, Error,Sources, Error,Strategies, Research,Strategy, Research,Technic, Research,Technics, Research,Technique, Research,Techniques, Research
D003824 Denture, Complete A denture replacing all natural teeth and associated structures in both the maxilla and mandible. Complete Denture,Complete Dentures,Dentures, Complete
D003828 Denture, Overlay Removable prosthesis constructed over natural teeth or implanted studs. Overdenture,Dentures, Overlay,Overdentures,Overlay Denture,Overlay Dentures
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D015921 Dental Implants Biocompatible materials placed into (endosseous) or onto (subperiosteal) the jawbone to support a crown, bridge, or artificial tooth, or to stabilize a diseased tooth. Dental Implants, Mini,Dental Prosthesis, Surgical,Implants, Dental,Dental Implant,Dental Prostheses, Surgical,Implant, Dental,Prostheses, Surgical Dental,Prosthesis, Surgical Dental,Surgical Dental Prostheses,Surgical Dental Prosthesis,Dental Implant, Mini,Mini Dental Implant,Mini Dental Implants
D017060 Patient Satisfaction The degree to which the individual regards the health care service or product or the manner in which it is delivered by the provider as useful, effective, or beneficial. Satisfaction, Patient
D018592 Cross-Over Studies Studies comparing two or more treatments or interventions in which the subjects or patients, upon completion of the course of one treatment, are switched to another. In the case of two treatments, A and B, half the subjects are randomly allocated to receive these in the order A, B and half to receive them in the order B, A. A criticism of this design is that effects of the first treatment may carry over into the period when the second is given. (Last, A Dictionary of Epidemiology, 2d ed) Cross-Over Design,Cross-Over Trials,Crossover Design,Crossover Studies,Crossover Trials,Cross Over Design,Cross Over Studies,Cross Over Trials,Cross-Over Designs,Cross-Over Study,Crossover Designs,Crossover Study,Design, Cross-Over,Design, Crossover,Designs, Cross-Over,Designs, Crossover,Studies, Cross-Over,Studies, Crossover,Study, Cross-Over,Study, Crossover,Trial, Cross-Over,Trial, Crossover,Trials, Cross-Over,Trials, Crossover

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