Connective Tissue Grafting for Single Tooth Recession Defects & the Impact of the Thickness of the Palatal Harvest Tissue: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Root coverage
研究概览
简要总结
The purpose of this study is to test if the thickness of the graft taken from the roof of the mouth, has a significant effect on the amount of attached tissue and the amount of root coverage that are attained when treating a single tooth with gingival recession.
详细描述
The goal of the study is to determine if the thickness of a tissue graft taken from the roof of the mouth, used to cover the exposed root of a tooth, affects the overall outcome of the root coverage, the health of the resulting tissue, as well as postoperative pain as reported by the patient. Connective tissue grafts will be harvested in different thicknesses, and results of the procedures will be compared. Qualified subjects will undergo a root coverage procedure, after random assignment to one of the groups. Regular recall visits to monitor healing at intervals of 1 week, 2 weeks, 1 month, and 3 months will be scheduled. Subjects will be asked to fill out patient response forms regarding pain and other symptoms at these visits. Photographs will be taken.
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 (Participant)
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
- •Age>18 years old
- •Absence of active periodontal disease
- •Single tooth (premolars and anterior teeth) with Miller class I or II gingival recession >= 2mm
- •Detectable Cemento-Enamel Junction (CEJ) -
排除标准
- •Smokers (>10 cigarettes/ per day)
- •Uncontrolled systemic diseases with compromised healing potential (DM with HbA1c >7%)
- •Active infectious diseases (hepatitis, tuberculosis, HIV, etc.)
- •Medication known to cause gingival enlargement
- •Patients taking anticoagulants with an international normalized ratio (INR) >2.5
- •Long-term (>2 weeks) use of antibiotics in the past 3 months
- •Pregnant or attempting to get pregnant
- •Sites with probing depth > 4mm
- •Recession adjacent to an edentulous area
- •Frenal and muscle attachment that encroach on the marginal gingiva
- •a. Can be included 2 months after surgical therapy to remove the frenum (frenectomy)
- •History of periodontal surgical treatment of the involved sites
- •Prosthetic crown, restorations or caries in the candidate tooth and adjacent teeth
- •Teeth with pulpal pathology
- •Severe teeth malposition and open contacts
- •Planned orthodontic treatment to commence within 1 year following procedure
- •Parafunctional habits -
结局指标
主要结局
Root coverage
时间窗: Upto 3 months
Amount of root coverage attained in millimeters
width of keratinized tissue
时间窗: Upto 3 months
Amount of zone of keratinized tissue attained in millimeters
次要结局
- duration of erythema and edema(Upto 3 months)
- amount of erythema and edema(Upto 3 months)
- thickness of keratinized tissue(Upto 3 months)
研究者
Evanthia Lalla
Professor of Dental Medicine (Periodontics)
Columbia University