Comparison of De-epithelialized Gingival Graft and Titanium-Prepared Platelet-Rich Fibrin in Interdental Papilla Defects: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- black triangle height
研究概览
简要总结
Objective: Titanium-prepared platelet-rich fibrin (T-PRF) has emerged as a promising biomaterial in periodontal regenerative procedures. The aim of this study will be to compare the clinical effectiveness of de-epithelialized gingival grafts (DGG) and T-PRF in the reconstruction of deficient interdental papillae using the tunnel technique.
Methods: A total of 34 patients presenting with 115 Class I and II interdental papilla defects will be enrolled in this study. Interdental papilla reconstruction will be performed using the tunnel technique in combination with either DGG or T-PRF. Demographic characteristics (age and sex), dentogingival variables (tooth shape, papilla location, jaw type, and papilla loss classification), and clinical parameters will be recorded. Clinical assessments will include probing depth (PD), gingival index (GI), plaque index (PI), gingival thickness (GT), keratinized tissue height (KTH), black triangle width (BTW), black triangle height (BTH), papilla fill percentage (%PF), and black triangle area (BTA). All clinical parameters will be assessed at baseline and at 1, 3, and 6 months following surgery.
详细描述
This randomized controlled clinical trial aims to evaluate the clinical efficacy of two autogenous grafting materials, de-epithelialized gingival graft (DGG) and titanium-prepared platelet-rich fibrin (T-PRF), when used in combination with the tunnel technique for interdental papilla reconstruction (IPR).
Interdental papilla defects may cause esthetic concerns, food impaction, and phonetic difficulties. Several surgical and non-surgical methods have been proposed for IPR. Connective tissue grafts (CTG) are considered the gold standard in many periodontal procedures; however, they require a second surgical site and are associated with increased patient discomfort. As alternatives, several types of PRF have been developed; however, T-PRF demonstrates superior properties, including improved biocompatibility and prolonged growth factor release.
The study is designed as a parallel-group randomized controlled trial. Thirty-four participants with Class I or II interdental papilla defects were included and randomly assigned to one of two groups:
Control Group: tunnel technique combined with DGG
Test Group: tunnel technique combined with T-PRF membrane
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 25 and 70 years.
- •Presence of papilla loss in the anterior region of the maxilla or mandible.
- •Classification of papilla loss as Class 1 or 2
- •Absence of systemic diseases.
- •No bleeding disorders that could interfere with the surgery.
- •Non-smoker and non-alcohol consumer.
- •Not pregnant or breastfeeding.
- •Absence of fillings, prostheses, or root canal treatments in the relevant teeth.
- •No prior surgical interventions in the target area.
排除标准
- •Smoking or alcohol consumption.
- •Presence of systemic diseases
- •Patients who did not attend postoperative follow-up appointments regularly.
- •Pregnant or breastfeeding individuals.
研究组 & 干预措施
De-epithelialized gingival graft
Participants assigned to this group received papilla reconstruction using a de-epithelialized gingival graft harvested from the palatal mucosa. Following tunnel preparation via the tunnel technique, the graft was de-epithelialized to a thickness of approximately 1.5 mm and inserted beneath the papillary flap to fill the defect. Graft stabilization and coronal advancement of the flap were achieved using suspension sutures anchored to preoperatively placed composite splints.
干预措施: De-epithelialized gingival graft (Procedure)
Titanium-prepared Platelet-Rich Fibrin
In this group, T-PRF membranes were prepared by centrifuging autologous blood in grade IV titanium tubes at 2,800 rpm for 12 minutes. The resulting fibrin clots were compressed to create standardized membranes, which were folded and placed into the prepared tunnel beneath the papilla. Similar to the DGG group, the flap was coronally repositioned and stabilized using suspension sutures attached to composite splints.
干预措施: Titanium-prepared Platelet-Rich Fibrin (Procedure)
结局指标
主要结局
black triangle height
时间窗: preoperative and postoperative (1, 3, 6 months)
The distance between the lowest point of the interdental contact area of teeth adjacent to the papilla and the highest point of the gingival papilla was measured.
black triangle width
时间窗: preoperative and postoperative (1, 3, 6 months)
The distance between the contact points of the papilla apex and the two adjacent teeth.
black triangle area
时间窗: preoperative and postoperative (1, 3, 6 months)
BTA was calculated as the area between the interdental contact points of the teeth and the gingival papilla using the formula: BTA= (BTH x BTW) /2
% Percentage fill
时间窗: preoperative and postoperative 6 months
The percentage change in black triangle height between two time intervals was calculated using the formula: %PD=(tendBTH - tfirstBTH) /tendBTH x100
次要结局
- keratinized tissue height(preoperative and postoperative (1, 3, 6 months))
- Gingival thickness(preoperative and postoperative (1, 3, 6 months))
研究者
Makbule Can
Research assistant
Pamukkale University