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.Discussion: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.Trial registration:This clinical trial was registered at the University Hospital Medical Information Network (UMIN) Center (UMIN000017883).
Purpose: Implant-assisted removable partial dentures (IARPDs) with short implants improve the oral functions of removable partial dentures (RPDs). This study aimed to compare the patient-reported outcomes of RPDs and IARPDs with short implants retained by magnetic attachments. Methods: We recruited 30 participants with mandibular Kennedy Class I or II and distal extension defects of three or more teeth. RPDs, IARPDs with a healing cap, and IARPDs with a magnetic attachment were evaluated across stages using patient-reported outcomes. All participants completed questionnaires (oral health-related quality of life [OHRQoL], patient general satisfaction, and patient's denture assessment [PDA]) at each stage. The OHRQoL was evaluated using the Oral Health Impact Profile-J 54 (OHIP-J 54) score. The general patient satisfaction was evaluated using a 100 mm visual analog scale. The Wilcoxon signed-rank test and Bonferroni correction were used to evaluate differences between the groups (α=0.05). Results: The OHRQoL of IARPDs was significantly higher than that of RPDs. IARPDs with a magnetic attachment had significantly better patient general satisfaction and PDA than IARPDs with a healing cap. Conclusions: The OHRQoL, patient general satisfaction, and PDA were improved by IARPD with a short implant using a magnetic attachment.
This study evaluated marginal bone loss and prosthetic complications associated with single implant-retained mandibular overdentures (1-IODs) with locator attachments. The 1-IOD was placed in the mandibular midline by using a conventional loading protocol in 22 patients with an edentulous mandible. Marginal bone loss at the start of loading and 12 months postoperatively was assessed by radiographic and crestal bone evaluation. The crestal bone was defined as the distance between the customized abutment shoulder and the top of the bone, as indicated by probing. In addition, implant stability quotient and prosthetic complications were recorded. The cumulative implant survival rate was 95.5%. Median implant stability quotient remained greater than 80, and median radiographic bone loss was 0.56 mm. Crestal measurement showed a median crestal bone loss of 0.16, 0.43, 0.39, and 0.52 mm on the buccal, right, lingual, and left sides, respectively. Both radiographic and crestal bone loss values significantly differed between the start of implant loading and 12 months postoperatively (except on the buccal and lingual sides; P < 0.05). The need to replace the nylon insert was the most common complication. Conventional loading of a 1-IOD with a locator attachment resulted in a high survival rate, good implant stability, and acceptable marginal bone loss. Materials and Methods Study designTwenty-two patients (10 men, 12 women; age range 61-91 years) with an edentulous mandible were recruited at the Dental Hospital of Tokyo Medical and Dental University from October 2015 through March 2016. The study inclusion criteria were presence of an edentulous mandible for at least 6 months; sufficient bone height (≥13 mm) and width (≥6.1 mm) at the mandible midline; written and spoken Japanese skills adequate to respond to questionnaires; and age older than 50 years. Patients were excluded if they had a medical contraindication to implant surgery, were receiving bisphosphonate therapy at the time of the study, had a history of chemotherapy or radiation therapy to the head or neck, smoked >20 cigarettes a day, or had an infection, a psychiatric disorder, a temporomandibular disorder, dry mouth, or oral dyskinesia.The sample size required for this study was estimated by using 100-mm Visual Analog Scale (VAS) scores for patient satisfaction, as described in the trial protocol of Kanazawa et al. [23]. Twenty participants were required for 80% power with a 2-sided alpha level of 0.05, when VAS scores were assumed to be normally distributed. Twenty-two participants were recruited, to allow for dropouts. The study protocol was approved by the
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