Wound Healing and Patient-Reported Outcomes After Autogenous Gingival Graft Harvesting From the Palate: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
The goal of this clinical trial is to evaluate whether two different techniques for treating palatal wounds-sutures and cyanoacrylate bioadhesive-can influence postoperative morbidity, clinical healing, and soft tissue dimensional changes in patients undergoing epithelialized gingival graft harvesting from the palate. The main questions it aims to answer are:
Does the use of cyanoacrylate bioadhesive reduce postoperative morbidity compared to sutures? Does the choice of wound treatment technique affect clinical healing and three-dimensional changes in soft tissues? Researchers will compare the sutures (control group) to the cyanoacrylate bioadhesive (test group) to determine if the bioadhesive leads to improved postoperative outcomes.
Participants will:
Undergo epithelialized gingival graft harvesting from the palate. Receive either sutures or cyanoacrylate bioadhesive for wound closure. Be monitored for postoperative morbidity, clinical healing, and soft tissue dimensional changes.
详细描述
Objectives Overall objective The aim of this randomized controlled clinical trial is to evaluate the clinical, volumetric, and patient-centered outcomes of autogenous gingival graft harvesting when treating the palate with different protective agents.
Specific objectives
- To assess wound healing, volumetric changes, post-operative pain and bleeding, eating discomfort, and analgesic consumption after EGG harvesting and protecting the palate with the following agents: (1) suturing; (2) cyanoacrylate bioadhesive.
- To assess any correlations between palate wound healing dynamics and patient-reported outcomes.
- To determine which demographic, anatomical, and surgical factors are correlated with higher post-operative pain and discomfort.
Hypothesis Null hypotheses
- H01: Using different palate protection agents provides similar wound healing and patient-reported outcomes.
- H02: There are no correlations between palate wound healing dynamics and patient-reported outcomes.
- H03: There are no correlations between demographic, anatomical, and surgical factors with higher post-operative pain and discomfort.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy individuals older than 18 years old;
- •Healthy periodontal status according to the AAP/EFP definition;
- •Full-mouth plaque (FMPS) and bleeding scores (FMBS) ≤ 20%;
- •No history of soft tissue harvesting.
排除标准
- •Pregnancy or lactation;
- •Self-reported smoking ≥10 cigarettes/day;
- •Metabolic diseases that negatively affect soft tissue healing (i.e., diabetes mellitus);
- •Any medication that may interfere with wound healing;
- •Removable maxillary prostheses;
- •Ongoing orthodontic therapy.
研究组 & 干预措施
Suture
This is the control group. In this group, 5-0 non-resorbable suspensory mattress sutures will be anchored to the soft tissues apical to the palatal wound area (5-0 Polypropylene, Prolene, Ethicon, Johnson and Johnson, New Brunswick, NJ, USA).
干预措施: Suture (Procedure)
Cyanoacrylate bioadhesive
This is the test group. In this group, several drops of a high-viscosity cyanoacrylate bioadhesive will be applied (Cuantum Oral Adhesive, Cuantum Medical Cosmetics S.L., Spain) to create a uniform adhesive layer. No sutures will be placed.
干预措施: Cyanoacrylate bioadhesive (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: 1 day, 3 days, 1 week, 2 weeks, 3 weeks, and 4 weeks
Minimum and maximum values \[0-100\] Higher scores mean worse outcome (more pain) A questionnaire will be prepared and handed to patients on the day of the surgery. Patients will be instructed to answer the questions at the same time of the day and refer only to the palatal wound. Postoperative pain will be assessed using a Visual Analog Score (VAS) at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, and 4 weeks postoperatively.
次要结局
- Postoperative bleeding(1 day, 3 days, 1 week, 2 weeks, 3 weeks, and 4 weeks.)
- Discomfort at eating(1 day, 3 days, 1 week, 2 weeks, 3 weeks, and 4 weeks)
- Analgesic consumption(during the first week)
- Oral Health Impact Profile 5 questionnaire (OHIP5)(At 8 weeks)
- Epithelial gingival graft dimensions(Per-operatively)
- Palatal Wound Healing Score(at 1 week, 2 weeks, 3 weeks, 4 weeks, and 8 weeks)
- Wound Area(at 1 week, 2 weeks, 3 weeks, 4 weeks, and 8 weeks)
- The mean distance between baseline and follow-up surfaces at the level of the Region Of Interest(at 1 week, 2 weeks, 3 weeks, 4 weeks, and 8 weeks)
- Linear Dimensional changes(at 1 week, 2 weeks, 3 weeks, 4 weeks, and 8 weeks)
- Initial palatal thickness(Baseline)
- Remaining palatal thickness(Immediate post-operative)
研究者
Gonzalo Blasi
Principal Investigator
Universitat Internacional de Catalunya