Evaluation of the Efficacy of Polynucleotide-Hyaluronic Acid Gel With Xenograft Compared to Xenograft Alone in Alveolar Ridge Preservation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Buccal Bone Plate Height
研究概览
简要总结
This randomized controlled clinical trial will evaluate the efficacy of polynucleotide-hyaluronic acid gel combined with xenograft and collagen membrane for alveolar ridge preservation following tooth extraction. Twenty participants will be randomly allocated into two parallel groups. The test group will receive xenograft mixed with polynucleotide-hyaluronic acid gel and covered with a collagen membrane, while the control group will receive xenograft with a collagen membrane alone. Clinical and CBCT assessments will be performed at baseline and during follow-up. After 6 months, ridge dimensional changes will be evaluated and core biopsies will be obtained at the time of implant placement for histological assessment.
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 outcome assessor and biostatistician will be blinded to group allocation. Blinding of the operator is not applicable.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-60 years.
- •Patients free from systemic diseases affecting wound healing or bone regeneration or contraindicating oral surgery.
- •Non-smokers with good oral hygiene.
- •Patients requiring tooth extraction in non-infected sockets due to endodontic failure, non-restorable caries, or trauma, and who will receive implant treatment.
- •Class I extraction sockets with intact alveolar bone walls.
- •Presence of teeth adjacent to the extraction site.
排除标准
- •Use of drugs affecting wound healing.
- •Heavy smokers (>10 cigarettes/day) or history of substance abuse.
- •Pregnant or breastfeeding women.
- •Previous grafting or surgical intervention in the study area.
- •Uncontrolled and/or untreated periodontal disease (active periodontitis).
- •Mentally or physically handicapped patients.
结局指标
主要结局
Change in Buccal Bone Plate Height
时间窗: Baseline and 6 months
The height of the buccal bone plate will be measured using digital superimposition of Cone Beam Computed Tomography (CBCT) scans obtained at baseline and 6 months. Measurements will be recorded in millimeters
次要结局
- Change in Palatal Bone Plate Height(Baseline and 6 months)
- Change in Horizontal Ridge Width(Baseline and 6 months)
- Percentage of New Vital Bone Formation(6 months)
- Percentage of Residual Graft Particles(6 months)
研究者
Maryam Mohamed Ali radhi alabbas
Master's Student in Periodontology
Cairo University