A Randomized Controlled Trial to Compare De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Pain after gingival graft harvesting
研究概览
简要总结
This study aims to compare the de-epithelized gingival graft (control group) and modified combined approach for connective tissue graft (test group) in patients undergoing palatal graft harvesting for mucogingival surgery in the oral cavity
详细描述
Harvesting a palatal mucosal tissue graft as an autologous donor for oral soft tissue augmentation is widely practiced. Tissue harvest in patients with anatomically thin phenotypes can cause significant morbidity and compromised healing process. The modified combined approach (MCA) for connective tissue grafts has the potential for faster healing and fewer postoperative complications, compared to the recommended harvesting technique of de-epithelized gingival graft (DGG). However, the modified combined approach for connective tissue grafts have yet to be extensively investigated.
This examiner-masked, randomized study aims to compare post-operative morbidity and treatment outcomes in patients undergoing modified combined approach for connective tissue graft (test group) compared to the de-epithelized gingival graft (control group) harvesting techniques in tissue augmentation.
Participants will be randomized into two groups receiving one of either modified combined approach for connective tissue graft or de-epithelized gingival graft. Collection of the study parameters will utilize both examiner-assessed, and patient reported outcomes.
The study will report on the optimum palatal mucosal graft harvesting technique in an Asian population. The findings of this study will be utilized to formulate clinical recommendations for soft tissues augmentation in this population.
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
- Triple (Participant, Investigator, 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
- •systemically healthy subjects;
- •able to give informed consent;
- •age ≥ 18 years;
- •requiring palatal tissue harvesting for soft tissue augmentation in the oral cavity
排除标准
- •subjects with periodontal diseases;
- •subjects with poor oral hygiene of >30% plaque index;
- •pregnant or lactating females;
- •subjects taking medication with any known effect on the periodontal soft tissues;
- •subjects with pathology in the oral cavity causing any degree of pain;
- •subjects wearing removable or fixed prothesis that is in contact with the donor site an
- •those with allergies to painkillers including ibuprofen and paracetamol.
结局指标
主要结局
Pain after gingival graft harvesting
时间窗: up to 3 months after surgery
Measured using a self-reported questionnaire that is designed by the research group. The pain will be measured using a visual analogue score (minimum value=0 and maximum value=10), and using a surrogate measure of amount of painkillers taken by the participants after the surgery (minimum value= 0, maximum value= 2 grams for paracetamol, 1200 mg for ibuprofen). Higher score on the visual analogue scale and higher amount of painkillers taken is a worst outcome.
次要结局
- Healing after gingival graft harvesting(up to 3 months after surgery)