Patient Satisfaction After Prosthetic Rehabilitation of Mandibular Single Denture With Two Implants Using Different Attachments: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient Satisfaction With Mandibular Implant-Retained Overdentures
研究概览
简要总结
This study is being conducted to compare two types of bar attachments used to support lower dentures in patients who have lost all their lower teeth. Many people who wear a single lower denture experience problems with stability, chewing, and comfort. Placing two implants in the lower jaw and attaching the denture to a bar can greatly improve how well the denture stays in place.
Traditionally, these bars have been made from metal. While effective, metal bars can place higher stress on the bone around the implants, which may lead to more bone loss over time. A newer material, PEEK (polyetheretherketone), is lighter and has flexibility closer to natural bone. This may reduce stress on the implants and help protect the surrounding bone.
In this randomized clinical trial, patients are assigned to receive either a PEEK bar or a metal bar to retain their lower denture. All participants receive two implants placed in the canine region of the lower jaw, followed by a bar-retained overdenture after healing.
The study follows patients for 12 months and measures:
Marginal bone loss: how much bone is lost around each implant, assessed through radiographs.
Patient satisfaction: how comfortable and functional the denture feels, including stability, chewing, speech, hygiene, and overall handling.
Early results show that both types of bars support the denture well, but implants connected to PEEK bars tend to show less bone loss after several months compared to those connected to metal bars. Patient satisfaction is high in both groups, with slightly higher scores reported by patients using PEEK bars, although not significantly different.
This study may help dentists choose the best bar material to improve long-term implant health and denture comfort.
详细描述
This randomized, parallel-group clinical trial evaluates the clinical performance of CAD/CAM-fabricated PEEK bars compared with traditional metal bars for retaining mandibular single overdentures supported by two implants. The study includes 20 fully edentulous mandibular patients aged 40-70 years who report functional difficulties with a single lower denture.
All participants undergo placement of two dental implants in the mandibular canine regions using a two-stage surgical protocol. After osseointegration, patients are randomly assigned to one of two groups:
PEEK bar group: overdentures retained using a digitally designed and milled PEEK bar.
Metal bar group: overdentures retained using a conventional metal alloy bar.
The scientific rationale for evaluating PEEK is based on its lower elastic modulus, which may allow more favorable stress distribution to peri-implant bone compared with the higher stiffness of metal bars. This biomechanical difference may influence implant survival, marginal bone remodeling, and perceived comfort.
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
Radiographic measurements of marginal bone loss and analysis of patient satisfaction scores are performed by an independent assessor who is blinded to group allocation. Participants and care providers are not blinded due to visible differences in bar materials and clinical procedures.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40 to 70 years
- •Mandibular single complete denture with complaints of poor retention or stability
- •Adequate bone volume in the mandibular canine regions to receive two dental implants without the need for bone grafting
- •Good general health allowing dental implant surgery
- •Willingness to participate and comply with study procedures and follow-up visits
- •Signed written informed consent
排除标准
- •Presence of uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus)
- •History of head and neck radiotherapy
- •Metabolic bone diseases or conditions affecting bone healing
- •Current smokers or tobacco users
- •Poor oral hygiene or inability to maintain oral hygiene
- •Active oral infections or untreated periodontal disease
- •Bruxism or severe parafunctional habits
- •Previous implant placement in the mandible
- •Pregnant or lactating women
结局指标
主要结局
Patient Satisfaction With Mandibular Implant-Retained Overdentures
时间窗: Baseline (at overdenture insertion), and at 3, 6, 9, and 12 months post-insertion
Description: Patient satisfaction will be evaluated using a Visual Analogue Scale (VAS). Participants will rate comfort, chewing efficiency, denture stability, speech, hygiene, ease of handling, and overall satisfaction. Scores will be recorded on a numerical scale and compared between intervention groups over the follow-up period.
Patient Satisfaction With Mandibular Implant-Retained Overdentures
时间窗: Baseline (at overdenture insertion), and at 3, 6, 9, and 12 months post-insertion
Description: Patient satisfaction will be evaluated using a Visual Analogue Scale (VAS). Participants will rate comfort, chewing efficiency, denture stability, speech, hygiene, ease of handling, and overall satisfaction. Scores will be recorded on a numerical scale and compared between intervention groups over the follow-up period.
次要结局
- Marginal Bone Loss Around Dental Implants(Baseline (at overdenture insertion), and at 3, 6, 9, and 12 months post-insertion)
- Marginal Bone Loss Around Dental Implants(Baseline (at overdenture insertion), and at 3, 6, 9, and 12 months post-insertion)
研究者
Sherif Aly Sadek
Associate Professor
Cairo University