Patient-reported Outcomes and Masticatory Performance of Mandibular Overdentures Retained by One Parasymphyseal Implant or Two Implants: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change from baseline in Oral Health Impact Profile for Edentulous Adults (OHIP-EDENT) total score
研究概览
简要总结
This randomized controlled trial compares a mandibular overdenture retained by one implant placed in the parasymphyseal or canine region with a mandibular overdenture retained by two implants placed in the interforaminal region in completely edentulous adults. Primary outcomes are oral health-related quality of life, patient satisfaction, and masticatory performance measured by a two-color chewing gum mixing test, assessed at baseline before implant surgery and at 3, 6, and 12 months after overdenture insertion.
详细描述
Eligible completely edentulous adults will be randomized to receive either one endosseous implant in the mandibular parasymphyseal or canine region on the preferred chewing side or two endosseous implants in the mandibular interforaminal region, followed by restoration with a locator-type attachment retained mandibular overdenture. Oral health-related quality of life, patient satisfaction, and masticatory performance assessed by a two-color chewing gum mixing test are collected at baseline before surgery and at 3, 6, and 12 months after overdenture insertion. Secondary outcomes include postoperative pain recorded during the early postoperative period, radiographic marginal bone level change, peri-implant clinical parameters, prosthetic maintenance events, and clinician chair time from implant surgery through overdenture insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessments (questionnaires and chewing gum mixing test) are performed by a blinded assessor; participants and treating clinicians are not blinded due to the nature of the interventions.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥40 years.
- •ASA I-II; favorable general health or adequately controlled systemic disease (e.g., hypertension, diabetes).
- •Skeletal Class I relationship.
- •Completely edentulous mandible and maxilla.
- •Technically acceptable complete dentures in both jaws for ≥3 and ≤24 months; dissatisfaction limited to mandibular retention/stability.
- •Adequate anterior mandibular bone for implant ≥3.5×10 mm confirmed on CBCT; no bone augmentation needed.
- •Normal mucosal resilience (~2 mm displacement).
- •Implant sites healed ≥4 months since extraction.
- •Willingness to be randomized and attend follow-ups; written informed consent.
- •Primary stability target ≥25 N-cm.
排除标准
- •Uncontrolled systemic disease; neurodegenerative disease; osteoporosis requiring antiresorptives.
- •Chronic systemic antibiotics/steroids; bleeding disorders; active cancer therapy; metabolic bone disease; HIV.
- •Investigational drug use within 30 days.
- •Alcohol dependence/illicit drug use; xerostomia (stimulated flow <0.7 mL/min).
- •Heavy smoking >20 cigarettes/day.
- •TMD/orofacial pain; severe bruxism; moderate/severe cognitive impairment.
- •Prior implant therapy.
- •Non-adherence risk or inability to attend longitudinal visits.
- •Insufficient prosthetic space for attachment housing: inter-arch vertical distance <8.5 mm at parasymphyseal/canine region.
- •Concurrent participation in another interventional study.
- •Erosive lichen planus or other significant oral mucosal disease; head-and-neck irradiation history.
- •Mandibular pathology on CBCT (e.g., cyst, tumor).
- •Ridge dimensions <6 mm width or <10 mm height at planned sites.
- •Active intraoral infection.
研究组 & 干预措施
Single-implant mandibular overdenture (parasymphyseal/canine, preferred chewing side)
One bone-level implant will be placed in the mandibular parasymphyseal/canine region on the preferred chewing side using a single-stage approach. A locator-type attachment (Sonator S) will be connected according to the manufacturer's instructions, and intraoral pick-up will be performed with cold-curing resin.
干预措施: Single-implant mandibular overdenture (parasymphyseal/canine region) (Procedure)
Two-implant mandibular overdenture (interforaminal)
Two bone-level implants will be placed bilaterally in the mandibular interforaminal region (bilateral lateral incisor-canine area) using a single-stage approach. Locator-type attachments (Sonator S) will be connected according to the manufacturer's instructions, and intraoral pick-up will be performed with cold-curing resin.
干预措施: Two-implant mandibular overdenture (interforaminal) (Procedure)
结局指标
主要结局
Change from baseline in Oral Health Impact Profile for Edentulous Adults (OHIP-EDENT) total score
时间窗: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion
Oral health-related quality of life (OHRQoL) will be assessed using the Oral Health Impact Profile for edentulous adults (OHIP-EDENT). OHIP-EDENT includes 19 items across 7 domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Each item is rated on a 5-point Likert scale from 0 ("never") to 4 ("very often"). Total score range is 0-76; lower scores indicate better oral health-related quality of life (OHRQoL).
Change from baseline in McGill Denture Satisfaction Questionnaire (MDSQ) total score
时间窗: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion.
McGill Denture Satisfaction Questionnaire (MDSQ) includes 8 core questions. Each item is scored on a 100-mm VAS (0 = "no satisfaction at all"; 100 = "complete satisfaction"). Total score = sum of 8 items (range 0-800); higher scores indicate greater satisfaction.
Change from baseline in masticatory performance measured by two-color chewing gum mixing test (Variance of Hue [VoH])
时间窗: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion.
Masticatory performance will be assessed using the two-color chewing gum mixing test. Chewed specimens are imaged and analyzed using ViewGum® software to calculate the Variance of Hue (VoH; range 0-1). Lower VoH indicates better color mixing (better masticatory performance).
次要结局
- Implant survival(Up to 12 months after overdenture insertion.)
- Visual Analog Scale (VAS) for postoperative pain(24 hours after implant surgery, 7 days after implant surgery, and 21 days after implant surgery.)
- Expected and Perceived Treatment Burden Questionnaire Score (overall and stage-specific)(Baseline (pre-surgery, expected burden); within 7 days after implant surgery (experienced surgical-stage burden); at overdenture insertion (experienced prosthodontic-stage burden).)
- Marginal bone level (MBL) change around implants (mm)(Overdenture insertion (baseline), 3 months after overdenture insertion, and 12 months after overdenture insertion)
- Peri-implant probing depth (PPD), mean per implant (mm)(Baseline (at overdenture insertion), 3 months after overdenture insertion, 12 months after overdenture insertion.)
- Modified plaque index (mPI)(3 months and 12 months after overdenture insertion.)
- Bleeding on probing (BOP) per implant (%)(Baseline (at overdenture insertion), 3 months after overdenture insertion, 12 months after overdenture insertion.)
- Prosthetic maintenance events and complications of implant-retained overdenture(Up to 12 months after overdenture insertion.)
- Treatment efficiency: total clinician chair time(From implant surgery through overdenture insertion.)
研究者
Rola Shadid
Associate Professor, Department of Prosthodontics, Arab American University (Palestine)
Arab American University (Palestine)