Patient's Satisfaction, Oral Health-related Quality of Life (OHRQoL) and Masticatory Efficiency of Mandibular Implant Supported Overdentures With Reduced Denture Base Extensions. A Within Subject Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- I- Patient satisfaction
研究概览
简要总结
This study aimed to compare reduced (partially extended) denture bases with fully extended bases regarding patient satisfaction, oral health-related quality of life (OHRQoL), and masticatory efficiency.
A within-subject study design was carried out; involving 20 completely edentulous participants aged 50-75 years, who received newly constructed conventional complete denture. Four parallel implants were installed in the interforaminal region, implant overdenture (IOD) retained by bar attachment was constructed for each patient and were provided with two different overdenture designs: (1)firstly a fully extended denture base (FIOD) (2) then a reduced (partially extended) denture base (RIOD). Each patient allowed to wear each types of overdentures for a period of 3 months prior to evaluation. The following outcome measures were assessed: Patient satisfaction, the Oral Health Impact Profile (OHIP-14), and Chewing efficiency were assessed.
详细描述
Study Design This study is a within-subject comparison aimed at evaluating the effects of two different mandibular overdenture base designs: the Fully Extended Denture Base (FIOD) and the Reduced (Partially Extended) Denture Base (RIOD).
Study Protocol
- Randomization: No randomization was done, the order of denture type presentation (was firstly fully extended then reduced design for each participant.
- Adaptation Period: Participants were allowed a 3-months adaptation period for each Overdenture type to ensure familiarity and comfort.
- Data Collection Schedule: Data for patient satisfaction, OHRQoL, and masticatory efficiency were collected at the end of each adaptation period. Data were collected at 3 months after use for each design, starting with FE design then RE.
Sample size and participants selection A total of 20 participants, aged 50-75 years, were recruited from the outpatient prosthodontic clinic, Faculty of Dentistry, Mansoura University. The sample size was determined based on a power analysis, aiming for an 80% power to detect significant differences at an alpha level of 0.05 and according to previous research in similar domains often utilized the same sample sizes.
Ethical Considerations The study was conducted in accordance with the Declaration of Helsinki, and ethical approval was obtained from the ethical committee, faculty of dentistry (A08011024RP). Informed consent was obtained from all participants prior to their involvement in the study. Participants were informed of their right to withdraw at any time without affecting their treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and 75 years.
- •Completely edentulous mandibular arch with adequate bone volume (≥10 mm in height and ≥ 6 mm in width at the implant site) and density to allow placement of 4 osseointegrated implants in the interforaminal region.
- •Good general health, with no history of systemic diseases that would contraindicate implant placement or the use of overdentures.
- •Presence of sufficient inter-arch space for overdenture construction and implant placement.
- •No history of severe bruxism or parafunctional habits that could affect implant stability or prosthetic outcomes.
- •Ability to understand and complete questionnaires regarding patient satisfaction and quality of life.
- •Willingness to comply with the study protocol and attending follow-up visits.
排除标准
- •History of temporomandibular joint disorders.
- •Neurological disorders affecting masticatory function.
- •Presence of uncontrolled systemic diseases.
- •Cognitive impairments affecting the ability to provide informed consent.
- •Severe bone resorption or contraindications for implant placement (e.g., insufficient ridge height or width).
- •Presence of systemic diseases affecting oral health (e.g., uncontrolled diabetes, systemic inflammatory disorders).
- •Inability to wear dentures for extended periods or intolerance to the study protocol
- •Inability to wear dentures for extended periods or intolerance to the study protocol
研究组 & 干预措施
fully extended denture base
Patient allowed to wear fully extended overdenture base for a period of 3 months prior to evaluation after implants installation (four parallel implants) in the interforaminal region.
干预措施: Four parallel implants were installed in the interforaminal region (Procedure)
partially extended denture base
Patient allowed to wear partially (reduced) extended overdenture base for a period of 3 months prior to evaluation after implants installation (four parallel implants) in the interforaminal region.
干预措施: Four parallel implants were installed in the interforaminal region (Procedure)
结局指标
主要结局
I- Patient satisfaction
时间窗: 3 months after each treatment
Patient satisfaction was assessed using a questionnaire based on visual analog scale (VAS). Satisfaction was tested concerning comfort, esthetics, stability, speaking retention, general satisfaction. Patients were requested to mark their answer (amount of satisfaction) on a 100-mm line (with zero indicates not satisfied at all and 100 indicates to completely satisfied). Higher VAS scores showed high satisfaction and lower scores indicated low satisfaction. The mean of the answers (length of the lines from zero to the marks in mm) for every question was subjected to statistical analysis. All dimensions of this instrument were highly associated with the items of general satisfaction (Awad \& Feine, 1998). The questionnaire was represented to the patients in Arabic
The oral health-related quality of life
时间窗: 3 months after each treatment
The oral health-related quality of life (OHRQoL) was assessed using the OHIP-14 oral health impact profile questionnaire, which consists of 7 categories: functional limitation, physical disability, physical pain
次要结局
- Masticatory (chewing) efficiency(3 months after each treatment)
研究者
Mohamed Elgamal
Associate professor of prosthodontics
Mansoura University