Morbidity Following Free Gingival Graft Harvesting With or Without the Use of the Palatal Shield Technique as a Wound Dressing: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
This randomized clinical trial aims to compare two techniques for managing the palatal donor site following gingival graft harvesting: a palatal stent made of flowable composite resin versus conventional suturing. The primary goal is to identify which method provides superior patient-reported outcomes (PROMs), thus optimizing postoperative comfort and overall patient well-being.
Systemically healthy patients, free of active periodontitis, requiring a palatal graft as part of periodontal or peri-implant mucogingival surgeries will be recruited and randomized into two groups. The experimental group will receive a palatal shield made of flowable composite resin adhesively secured to adjacent teeth, whereas the control group will undergo conventional suturing. In both groups, a collagen hemostatic sponge will be placed to aid hemostasis.
Primary endpoints include postoperative pain measured daily via Visual Analog Scale (VAS), general patient comfort during daily activities such as eating and oral hygiene, and overall patient satisfaction assessed using Likert scales or validated questionnaires.
Secondary endpoints involve clinical healing evaluated clinically and photographically at 7 and 14 days postoperatively, incidence of postoperative complications (e.g., prolonged bleeding, infections), analgesic consumption, functional recovery time, and oral health-related quality of life measured by the OHIP-14 questionnaire.
Statistical analysis will compare groups using appropriate parametric or non-parametric tests for continuous variables (pain scores, recovery time) and Chi-square or Fisher's exact tests for categorical variables. Pain progression over time will be assessed using repeated-measures ANOVA or an equivalent non-parametric test.
This study will help determine whether the palatal stent represents a superior alternative to conventional techniques in improving patient comfort, healing, and postoperative oral health-related quality of life in mucogingival surgical procedures.
详细描述
Objective This study aims to compare the effectiveness of palatal stent management versus conventional suturing on patient-reported outcome measures (PROMs), to identify the optimal strategy for managing palatal donor sites and improving postoperative patient well-being.
Primary Endpoints
- Postoperative Pain: Measured daily using a Visual Analog Scale (VAS) during the first postoperative week.
- General Patient Comfort: Evaluated using standardized questionnaires assessing discomfort during daily activities such as eating and oral hygiene.
- Patient Satisfaction: Assessed using Likert scales or validated questionnaires.
Secondary Endpoints
- Clinical Healing of Donor Site: Evaluated clinically (e.g., redness, swelling, infection signs) and photographically at 7 and 14 days postoperatively.
- Postoperative Complications: Frequency of events including prolonged bleeding, infection, or need for additional intervention.
- Analgesic Use: Number and duration of analgesic doses prescribed or voluntarily taken by patients.
- Functional Recovery Time: Days required for patients to resume normal activities (e.g., eating without difficulty, returning to work).
- Oral Health-Related Quality of Life: Evaluated using standardized questionnaires such as OHIP-14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (≥18 years old) requiring periodontal or peri-implant mucogingival surgery involving palatal graft harvesting.
- •Systemically healthy patients without medical conditions affecting wound healing.
- •Patients free of active periodontal disease at the time of surgery.
- •Patients able and willing to comply with postoperative instructions, complete questionnaires, and attend follow-up appointments.
- •Patients providing informed written consent to participate in the study.
排除标准
- •Patients with systemic diseases that could influence wound healing (e.g., diabetes, autoimmune disorders).
- •Patients with active periodontal disease.
- •Patients taking medications known to affect bleeding or healing (e.g., anticoagulants, immunosuppressants, steroids).
- •Patients who are pregnant or breastfeeding.
- •Patients who have undergone previous surgical interventions in the palatal donor area.
- •Patients with allergies or hypersensitivity to composite resin materials or collagen-based products.
- •Patients unable or unwilling to comply with postoperative instructions or follow-up visits.
- •Patients with poor oral hygiene or uncontrolled plaque accumulation.
研究组 & 干预措施
Test
The palatal wound will be protected with composite resin
干预措施: Palatal stent as wound dressing (Procedure)
Control
The palatal wound will be covered with collagen sponge
干预措施: Conventional suturing (Procedure)
结局指标
主要结局
Postoperative Pain
时间窗: The day of the intervention and every day for the first week
Measured daily using a Visual Analog Scale (VAS) during the first postoperative week.
General Patient Comfort
时间窗: The day of the intervention, every day during the first week and 14 days after the intervention
Evaluated using standardized questionnaires assessing discomfort during daily activities such as eating and oral hygiene
Patient Satisfaction
时间窗: The day of the intervention, every day during the first week and 14 days after the intervention
Assessed using Likert scales and validated questionnaires
次要结局
- Analgesic Use(Day of the intervention and every day during the first week.)
- Oral Health-Related Quality of Life(At day 14)
- Clinical Healing of Donor Site(At 7 and 14 days postoperatively.)
- Functional Recovery Time(Every day during the first week and at day 14)
- Postoperative Complications(Every day during the first week)
研究者
Nicola Alberto Valente, DDS, MS, PhD
Associate Professor
University of Cagliari