Impact of Hyaluronic Acid and Bone Graft on PeriImplant Tissue Phenotype."A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effect of hyaluronic acid (HA) and particulate bone graft on the peri-implant tissue phenotype in patients receiving dental implants. Healthy adult participants requiring dental implant placement will be randomly allocated into one of three equal groups (12 implants per group): Group 1 will receive dental implants combined with hyaluronic acid gel (Gengigel); Group 2 will receive dental implants combined with both hyaluronic acid and particulate bone graft; and the control group will receive dental implants alone.
Clinical and radiographic assessments will be performed using a customized measurement stent to ensure standardized evaluations at baseline, immediately postoperatively, and at 8 and 16 weeks of follow-up. The primary and secondary outcomes include alterations in ridge width, keratinized tissue width/thickness, radiographic soft tissue height, and marginal bone height. The study aims to determine whether the adjunctive use of hyaluronic acid and bone grafts enhances the quality of the peri-implant soft and hard tissue phenotype.
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
The outcomes assessor was blinded to the group allocation to prevent bias during the evaluation of soft tissue width and crestal bone measurements.
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥ 18 years old.
- •Partially edentulous patients requiring dental implant placement.
- •Good oral hygiene (Calibrated Gingival Bleeding Index (GBI) < 10%, O'Leary ---Plaque Index (PI) < 10%).
- •Sufficient bone volume for implant placement.
排除标准
- •Systemic conditions affecting bone healing (e.g., uncontrolled diabetes).
- •Smoking > 10 cigarettes/day.
- •Medications affecting bone metabolism (e.g., bisphosphonates).
- •Active periodontal disease.
- •Pregnant or lactating women.
研究组 & 干预措施
Group 1: Dental Implants + Hyaluronic Acid
Patients receive dental implants combined with hyaluronic acid gel applied at the implant site.
干预措施: Dental Implants with Hyaluronic Acid (Procedure)
Group 2: Dental Implants + Hyaluronic Acid + Bone Graft
Patients receive dental implants combined with hyaluronic acid gel and particulate bone graft applied at the implant site.
干预措施: Dental Implants with Hyaluronic Acid and Particulate Bone Graft (Procedure)
Group 3: Control Group: Dental Implants Alone
Patients receive standard dental implants placement alone without any adjunctive materials.
干预措施: Standard Dental Implants Placement only (Procedure)
结局指标
主要结局
未指定
次要结局
- Postoperative Pain Scores(Three times daily (morning, afternoon, and evening) for the first 7 days postoperatively)
研究者
Monya Noori Hassan
Principal Investigator
Al-Mustansiriyah University
