Evaluation of Free Gingival Graft Timing in Staged Guided Bone Regeneration: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Buccal soft tissue profile
研究概览
简要总结
This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft.
详细描述
This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft. The primary objective is to assess the influence of the tissue graft timing on the outcomes of the guided bone regeneration. The secondary goal is to compare the complications that may arise following the two procedures before implant placement.
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 least 18 years old
- •No uncontrolled medical conditions or medications that will affect their bone healing.
- •Good oral hygiene is defined as a full-mouth plaque score ≤25%
- •Must be able to read and understand the informed consent document.
- •Has a need for implants to replace missing tooth/teeth in at least 1 quadrant of the mouth.
- •Insufficient alveolar ridge width for endosseous implant placement, defined as 5 mm or less, as determined by bone sounding and CBCT scan.
- •The patient and/or guardian is willing and able to comply with pre-operative and post-operative diagnostic and clinical evaluations required.
- •The patient is not pregnant or breastfeeding.
排除标准
- •Active infectious diseases.
- •Liver or kidney dysfunction/failure.
- •Uncontrolled diabetes (HbA1c ≥ 8.5).
- •Active cancer treatment - such as active chemotherapy radiation therapy, or radiotherapy performed within ≤12 months from the procedure.
- •Taking medications that will affect their bone healing (for example, bisphosphonates and long-term anti-inflammatory medications).
- •Metabolic bone diseases that affect bone healing such as osteoporosis.
- •Pregnant or lactating women (self-reported).
- •Current tobacco and Marijuana smokers have 10 or more cigarettes per day, and former smokers (> 10 cigarettes) who quit < 10 ago (self-reported).
- •Poor oral hygiene.
- •Vertical loss of bone at the edentulous ridge.
- •History of periodontal disease.
- •The patient is pregnant or breastfeeding
研究组 & 干预措施
FGG before GBR
Free Gingival Graft(FGG) before the guided bone regeneration(GBR)
干预措施: FGG Before GBR (Procedure)
FGG after GBR
Free Gingival Graft(FGG) after the guided bone regeneration(GBR)
干预措施: FGG after GBR (Procedure)
结局指标
主要结局
Buccal soft tissue profile
时间窗: Baseline to 12 months
The assessment involves measuring the profile of the buccal soft tissue from the implant shoulder.
Volumetric outcome assessment
时间窗: Baseline to 12 months
The volumetric outcomes of interest will be volume change in mm3 (Vol) and the mean distance between the surface/mean thickness of the reconstructed volume in mm.
次要结局
未报告次要终点
研究者
Hussein Basma
Clinical Assistant Professor, Principal Investigator
University of Alabama at Birmingham