Clinical And Radiographic Evaluation of Mandibular Implant Assisted Overdenture Between Bar Attachment and Bar With OT Equator Attachment: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Retention of Mandibular Overdenture
研究概览
简要总结
This clinical study will evaluate two types of attachment systems used to support lower dentures in patients who have lost all their lower teeth. All participants will receive dental implants in the lower jaw, and a complete denture that attaches to these implants for better stability and comfort.
The study compares two options:
A traditional bar attachment
A bar with additional OT Equator attachments, which are designed to improve denture retention and reduce wear
Each participant will receive three implants in the lower jaw, and either a bar attachment alone or a bar with OT Equator attachments will be placed. The goal is to find out which method provides better retention of the denture, causes less bone loss around the implants, has less wear on the attachment parts, and leads to higher patient satisfaction.
Participants will be followed over several months. Their denture retention will be tested using a digital force meter, bone levels will be measured through radiographs, cap wear will be examined using an electron microscope, and satisfaction will be recorded using a questionnaire.
This study is being conducted at Cairo University and is self-funded by the primary investigator. Participation is voluntary and does not involve any financial cost to participants.
详细描述
This randomized controlled clinical trial aims to compare the clinical and radiographic outcomes of mandibular implant-supported overdentures using two different attachment systems: bar attachment alone (control group) versus bar with OT Equator attachments (intervention group).
A total of 22 completely edentulous participants will be randomly assigned to either group. Each participant will receive three dental implants placed in the anterior mandible. After healing, bar attachments will be fabricated and delivered. In the intervention group, OT Equator attachments will be added to the bar to enhance retention and flexibility. All participants will receive complete upper and lower dentures.
The study's primary outcome is denture retention, measured using a digital force gauge. Secondary outcomes include crestal bone loss (assessed radiographically), cap wear (measured via electron microscopy), and patient satisfaction (evaluated with a Visual Analog Scale questionnaire).
This study will help inform clinical decisions regarding attachment systems for mandibular overdentures and may provide evidence for improved long-term function and patient-reported outcomes.
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
Only the outcome assessor (statistician) is blinded to the group allocation. Due to the nature of the interventions, participants and investigators cannot be blinded.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completely edentulous healthy patients.
- •Age between 35 and 65 years.
- •Sufficient bone in the anterior and premolar-molar regions (≥11 mm).
- •Adequate inter-arch space (12-14 mm).
排除标准
- •Severe maxillomandibular skeletal discrepancy.
- •Presence of parafunctional habits such as clenching or bruxism.
- •Temporomandibular joint disorders.
- •History of drug abuse.
- •History of head and neck radiation.
- •Systemic disorders that could prevent surgery or affect bone quality (e.g., uncontrolled diabetes, osteoporosis).
研究组 & 干预措施
Bar Attachment Only
Participants in this group will receive a mandibular implant-assisted overdenture supported by a milled bar attachment only. Three implants will be placed in the anterior mandible (midline and canine regions), and a bar attachment will be fabricated without any additional retentive elements.
干预措施: Bar Attachment (Device)
Bar with OT Equator Attachment
Participants in this group will receive a mandibular implant-assisted overdenture supported by a milled bar with OT Equator attachments. Three implants will be placed in the anterior mandible (midline and canine regions). Two OT Equator attachments will be incorporated into the bar to enhance retention and stress distribution.
干预措施: Bar with OT Equator Attachment (Device)
结局指标
主要结局
Retention of Mandibular Overdenture
时间窗: At baseline (T0) and 6 months post-insertion (T6)
Retention will be measured using a digital force gauge. A standardized technique will be used to measure the force required to dislodge the mandibular overdenture by pulling upward from a geometric center marked on the denture.
次要结局
- Crestal Bone Loss Around Implants(At baseline (T0) and 6 months post-insertion (T6))
- Patient Satisfaction(At 6 months post-insertion (T6))
- Cap Wear of Attachment System(At baseline (T0) and 6 months post-insertion (T6))
研究者
Hala Abdel salam Selim
PhD Candidate
Cairo University