Tuberosity Versus Palatal Donor Site for Subepithelial Connective Tissue Graft in Root Coverage Therapy: a Randomized Clinical Trial (TOPGRAFT)
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 主要终点
- Gingival recession
研究概览
简要总结
Gingival recessions are characterized by the apical migration of the marginal gingivae toward the cemento-enamel junction. Our team in France reported that 84,6% of the population exhibited gingival recession. Other epidemiologic data report that 25% of an american population exhibit recessions deeper than 3mm.
Recessions may be associated with thermic or mecanic related pains and increased wear of the roots. It may causes aesthetic prejudice on smiling. It may also complicate prosthetic reconstruction when the volume of tissue are insufficient. A study on a Brazilian population reported that recessions negatively impacted the quality of life in terms of esthetics and root sensitivity.
Many surgical procedures have been created to treat these recessions. Most of them include a gingival graft by mean of a sub-epithelial connective tissue graft. Usually it is harvested in the hard palate. However, the early healing of the palate may be associated with important pain and discomfort. Another harvesting site is the retromolar tuberosity. It seems to be of higher tissular quality and lower healing complications. However its limited volume prevent the harvesting of large graft.
Almost no studies have compared the clinical outcome between palatal and tuberosity graft. A retrospective study of our team reported higher rate of complet root coverage with tuberosity graft versus palatal graft (OR=3,78 IC95%). After this observational study, our work introduce a interventional comparison between the two harvesting sites.
详细描述
Recruitment and inclusion:
Patients will be recruited from the consultation of the service of periodontology at Rothschild hospital, Paris, France. All eligible willing participant is included between 2 to 8 weeks before intervention. At that time, data are collected, including periodontal parameters and standardized photographs.
Randomization:
It is performed right before intervention by the operator via CleanWEB. Surgical protocol Both test and control groups will be treated with the same flap design. Patient will receive local anaesthesia at the recession and donor site (articaine hydrochloride 7200 mg/1.8 ml, adrenalin 1800 mcg/1.8 ml).
Envelope technique:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females must be at least 18 years of age.
- •Patients must be in good general health without any systemic diseases.
- •Presence of buccal gingival recession (Miller's Class I and II) >2 mm.
- •Identifiable cemento-enamel junction.
- •The tooth with a gingival recession is a vital tooth.
- •Accessible tuberosity.
- •Plaque Index and Gingival bleeding index less than 20%.
- •Use an atraumatic dental brushing technique.
- •Provide signed and dated informed consent form.
- •Social health insurance.
排除标准
- •The tooth with a gingival recession is a molar
- •Prosthetic crown, restoration or tooth decay involving the CEJ
- •Previous periodontal plastic surgery in the area
- •Smokers up to 10 per day.
- •Patient with untreated periodontal disease.
- •Presence of clinical signs of active periodontal disease
- •Known pregnancy in progress
- •Contraindication to surgery
- •Patient deprived of liberty or under legal protection measure.
研究组 & 干预措施
Control Group
Envelope technique + sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure
干预措施: Sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure (Procedure)
Test Group
Envelope technique + sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure
干预措施: Sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure (Procedure)
结局指标
主要结局
Gingival recession
时间窗: 12 months
The distance from CEJ to the gingival margin in the mid-buccal site of the treated tooth. Recession will be measured where there is the greatest distance between the marginal gingiva and the cemento-enamel junction (CEJ) in the vertical direction.
次要结局
- Pocket depth(12 months)
- Keratinized tissue heigth(12 months)
- Aesthetic evaluation(12 months)
- Post operative morbidity assessment(2 weeks)
- Aesthetics and satisfaction assessment(12 months)
- Duration of surgery(intraoperative)