Use of a Custom-Made Acrylic Palatal Stent to Minimize Donor Site Morbidity After Suture-Free Epithelialized Gingival Graft Harvesting: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Postoperative pain at the palatal donor site
研究概览
简要总结
Epithelialized gingival graft (EGG) harvesting from the palate is associated with postoperative morbidity, including pain and bleeding, due to healing by secondary intention. The effectiveness of palatal stents in reducing donor-site morbidity, particularly in suture-free techniques, remains unclear.
This randomized controlled clinical trial evaluates the effect of a custom-made acrylic palatal stent (APS) compared with no stent on postoperative outcomes following EGG harvesting.
The primary outcome is postoperative pain assessed using a visual analog scale (VAS). Secondary outcomes include other patient-reported measures, clinician-reported healing, and exploratory assessments of tissue healing.
详细描述
Epithelialized gingival graft (EGG) harvesting is widely used in periodontal plastic surgery but is associated with postoperative discomfort at the palatal donor site. Healing occurs by secondary intention and may result in pain, bleeding, and delayed recovery.
Palatal stents have been proposed as a mechanical approach to protect the wound and reduce morbidity; however, evidence supporting their effectiveness, especially in suture-free techniques, is limited.
This randomized controlled, assessor-blind, parallel-arm clinical trial aims to evaluate the effect of a custom-made acrylic palatal stent (APS) on postoperative morbidity following EGG harvesting. Patients were randomly assigned to receive APS or no stent after surgery.
The primary outcome is postoperative pain. Secondary outcomes include patient-reported measures, clinical healing parameters, and exploratory assessments of tissue healing.
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
- •Adults ≥18 years of age
- •Patients requiring periodontal plastic surgery involving epithelialized gingival graft (EGG) harvesting from the palate
- •Indications including keratinized tissue augmentation, soft tissue thickness augmentation, or root coverage procedures
- •Adequate palatal tissue thickness to allow graft harvesting (≥2 mm)
- •Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤20%
- •Ability to understand and complete patient-reported outcome questionnaires
- •Signed informed consent
- •Willingness to comply with study procedures and follow-up visits
排除标准
- •compromised general health contraindicating the procedures (ASA III-VI)
- •heavy smokers (≥ 10 cigarettes/day),
- •systemic diseases or medications affecting treatment outcomes,
- •known allergies or hypersensitivity to ibuprofen.
结局指标
主要结局
Postoperative pain at the palatal donor site
时间窗: 7 days after surgery
Postoperative pain assessed using a 100-mm visual analog scale (VAS), where 0 indicates no pain and 100 indicates worst imaginable pain. Patients will record pain daily using standardized questionnaires
次要结局
- Postoperative bleeding(Daily from Day 1 to Day 7, Day 14, 21, 28)
- Postoperative swelling(Daily from Day 1 to Day 7, day 14, 21, 28)
- Analgesic consumption(7 days after surgery)
- Oral health-related quality of life (OHIP-14)(Baseline, 7 days, 14 days, 21 days, 28 days)
- Willingness to undergo retreatment(28 days after surgery)
- Epithelialization(7 and 14 days after surgery)
- Clinical wound healing(7, 14 days)
研究者
Mario Aimetti
Prof. Mario Aimetti
University of Turin, Italy