Is the Stabilization of a Mandibular Overdenture Employing Four Novel One-piece Immediately Loaded TiZr Implants With Miniaturized Stud-type Attachments a Feasible Alternative to Two Two-piece Early Loaded Tissue-level Implants With Regular Stud-type Attachments?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Geriatric Oral Health Assessment Index (GOHAI)
研究概览
简要总结
H0: "Within the first year post-placement, four interforaminally placed, immediately loaded 2.4 mm narrow-diameter one-piece TiZr implants with miniaturized stud-type attachments show improved patient-reported outcome measures (PROMS) compared to two interforaminally placed, early loaded, TiZr two-piece implants with stud-type attachments to retain a mandibular overdenture."The specific aim is to compare both treatment alternatives to evaluate which one may be recommended for elderly edentulous patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At patient level:
- •Written informed consent
- •Age ≥ 18 years
- •Sufficient complete dentures (Marxkors and Ferger, 1989) not older than 1 year
- •Patient is unsatisfied with mandibular denture to the degree that he/she seeks treatment
- •At site level:
- •Healed edentulous mandible (minimum 8 weeks since last extraction)
- •Minimal ridge dimensions 5.5 mm (width) by 12 mm (height) in the anterior (interforaminal) area, allowing the placement of 3.3 (endosseous diameter) by 10 mm (length) implants
- •Opposing dentition: complete denture on a edentulous maxilla
- •Physical status (PS) 1 and 2 (American Society of Anesthesiologists)
排除标准
- •At patient level
- •Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance to the protocol
- •Any disorder that would interfere with wound healing or represent a contraindication for oral surgery such as, but not limited to, uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates
- •Pregnancy or lactation
- •Heavy smoking habit with > 20 cig/d
- •Severe bruxism or clenching habits, present oro-facial pain
- •At site level:
- •Ridge defects requiring staged bone augmentation procedures (simultaneous Guided Bone Regeneration (GBR) within the ridge contour allowed)
研究组 & 干预措施
Control-group
Two Tissue Level TiZr Sand blasted long grit acid-etched (SLA) implants placed in positions 33 and 43 (diameter 3.3mm, length ≥10mm), early loading
干预措施: early loading (Procedure)
Experimental-group
Four narrow-diameter implants (NDI) TiZr SLA implants in positions 34, 32, 42, and 44 (diameter 2.4mm, length ≥10mm), immediate loading
干预措施: immediate loading (Procedure)
结局指标
主要结局
Geriatric Oral Health Assessment Index (GOHAI)
时间窗: One-year follow-up
Change from baseline questionnaires in Oral Health Related Quality of Life (OHRQoL). Scores 0-60: higher values represent lower OHRQoL
次要结局
- Additional PROM Denture Satisfaction Index (DSI)(Baseline, follow-up (up to 365 days))
- Implant Survival(at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up)
- Additional Oral Health Impact Profile for edentulism (OHIP-EDENT)(Follow-up (up to 365 days))
- Implant Success(at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up)
- Plaque Index(at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up)
- Bleeding Index(at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up)
- Pocket Probing depth(at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up)
- In-vivo evaluated loss of retentive force(after implant loading (expected to be after 6 weeks on average) and at follow-up (up to 365 days))
- Time-Cost-Analysis(After surgery, after implants loading, after follow-up (up to 365 days))
- Chewing Efficiency(Baseline, follow-up (up to 365 days))
- Cost Effectiveness and Willingness to Pay(Total change and time at 1y follow-up)
- Prosthetic Survival(Baseline, follow-up (up to 365 days))