Alternative Gingival De-Epithelialization Techniques: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Histomorphometric Comparison
研究概览
简要总结
The goal of this clinical trial is to compare different de-epithelialization methods in patients undergoing soft tissue augmentation surgery. The main questions it aims to answer are:
• Which technique is superior for de-epithelialization in terms of remaining epithelium, wound healing of the donor site, and clinical outcomes?
详细描述
Participants will be randomly assigned to one of four surgical techniques during their surgical procedure and the wound site will be assessed on post-operative days 1, 7, 14, and 21.
Researchers will compare the use of mucotome, Er:YAG laser, surgical diamond bur, or blade to observe patterns of wound healing and assess if one method is superior in terms of removing the epithelium.
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)
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
- •American Society of Anesthesiologists (ASA) Physical Status Classification I or II
- •Subjects undergoing periodontal surgical procedures that involve harvesting of soft tissue samples, who have a treatment plan including the use or removal of keratinized mucosa or subepithelial connective tissue that will not require additional anesthesia for sample collection
- •Adequate physical and mental health to undergo routine dental treatment
- •Ability and willingness to follow instructions related to the study procedures
排除标准
- •Poorly controlled diabetes, defined as HbA1c >/= 7.0
- •Autoimmune or inflammatory conditions such as systemic lupus erythematous, rheumatoid arthritis.
- •Pregnant women or nursing mothers, or unsure of pregnancy status (self-reported)
- •Severe hematologic disorders, such as leukemia or hemophilia
- •Subjects on anticoagulant or antiplatelet therapy
- •Local or systemic infection that may interfere with healing
- •Hepatic or renal diseases
- •Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy
- •History of antibiotic or immunosuppressant use in the last 3 months
- •Subjects on concomitant drug therapy for systemic conditions that may affect outcomes of the study
- •Current smokers (CDC definition): heavy smokers: subjects who have smoked >10 cigarettes per day within 6 months of study onset, and have smoked >100 cigarettes in their lifetime
研究组 & 干预措施
Surgical Blade
A surgical blade will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
干预措施: Surgical Blade (Procedure)
Mucotome
A mucotome will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
干预措施: Mucotome (Procedure)
Diamond Bur
A diamond bur will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
干预措施: Diamond Bur (Procedure)
Er:YAG Laser
A dental laser will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
干预措施: Er:YAG Laser (Procedure)
结局指标
主要结局
Histomorphometric Comparison
时间窗: After Day 0 (Baseline surgery)
Histomorphometric evaluation of the relative proportion of epithelial tissue remnants (percentage) after de-epithelialization of the CTG
次要结局
- Wound healing(Days 1, 7, 14, 21 (Post-operative) after surgery)
- Surgical Time(Day 0 (Baseline Surgery))
- Patient-reported outcome measures(Days 1, 7, 14, 21 (Post-operative) after surgery)
研究者
Sandra Hyon Mi Stuhr
Clinical Assistant Professor of Dentistry, Periodontics and Oral Medicine
University of Michigan