Patient Morbidity and Root Coverage Outcome After Subepithelial Connective Tissue Graft Used in Combination With Coronally Advanced Flap and Tunneling Technique: a Comparative Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patient morbidity
研究概览
简要总结
The aim of this randomized-controlled clinical trial is to compare the patient morbidity and root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with a coronally advanced flap (CAF) and tunnel technique (TT).
The primary objective of the study is to demonstrate the superiority in terms of the post-operative course and pain of the CAF+SeCTG when compared to the TT.
详细描述
The aim of this randomized-controlled clinical trial is to compare the patient morbidity and root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with a coronally advanced flap (CAF) and tunnel technique (TT).
The study will be designed as a single-centre, randomized, clinical trial on the treatment of single gingival recessions. The study assessed two different treatment modalities: the tunnel technique with subepithelial connective tissue graft (TT), compared to the coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) in terms of clinical outcomes, and post operative morbidity.
50 patients with one gingival recession each will be treated. Evaluation of patient morbidity will be performed 3 days and 1 week after the surgery. Clinical outcomes will be evaluated 12 months post operatively. Clinical outcomes included percentage of root coverage (RC) and complete root coverage (CRC) will be recorded. Patient morbidity will be evaluated with questionnaires.
Clinical measurements (1 week before surgery and at the 12 months follow-up)
- Gingival recession height (GH)
- Probing depth (PD)
- Clinical attachment level (CAL)
- Height of keratinized tissue (KTH)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single Miller's Class I or Class II recession defects 2 to 4 mm range of recession height will be included presence of identifiable cemento enamel junction (CEJ) presence of a root abrasion, but with an identifiable CEJ, will be accepted; periodontally and systemically healthy no contraindications for periodontal surgery no taking medications known to interfere with periodontal tissue health or healing no periodontal surgery on the involved sites.
排除标准
- •Subjects smoking more than 10 cigarettes a day will be excluded. Recession defects associated with caries or restoration as well as teeth with evidence of a pulpal pathology will not be included.
- •Molar teeth will also be excluded.
研究组 & 干预措施
Root coverage with Tunnel (TT)
The tunnel technique with subepithelial connective tissue graft (TT+SeCTG) will be utilized to cover the denude root surface
干预措施: Tunnel technique with subepithelial connective tissue (Procedure)
Root coverage with Tunnel (TT)
The tunnel technique with subepithelial connective tissue graft (TT+SeCTG) will be utilized to cover the denude root surface
干预措施: Analgesic Therapy (Drug)
Coronally advanced flap (CAF+SeCTG)
The Coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) will be utilized to cover the denude root surface
干预措施: Coronally advanced flap (Procedure)
Coronally advanced flap (CAF+SeCTG)
The Coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) will be utilized to cover the denude root surface
干预措施: Analgesic Therapy (Drug)
结局指标
主要结局
Patient morbidity
时间窗: 3 days after intervention
Quantity of analgesics taken during the first week post-surgery. Patients' post operative discomfort, bleeding, stress and inability to chew was evaluated with a questionnaire given to patients 3 days following surgery.
次要结局
- Clinical measurements GH(12 months follow-up)
- Clinical measurements KTH(12 months follow-up)
- Clinical measurements PD(12 months follow-up)
- Clinical measurements CAL(12 months follow-up)
研究者
Luca Gobbato
Clinical Faculty Department of Periodontology
University of Padova, School of Dental Medicine