A COMPARATIVE STUDY OF ROOT COVERAGE USING OrACELL™ VERSUS SUBEPITHELIAL CONNECTIVE TISSUE GRAFT: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Gingival Recession (Root Coverage)
研究概览
简要总结
The purpose was to compare root coverage outcomes between autogenous connective tissue graft (CTG) and decellularized human dermis (OrACELL™) in areas of facial gingival recession.
详细描述
Twenty-four non-smoking, healthy patients, with 2mm or greater facial gingival recession at a minimum of one site that classified as a Miller Class I, II, or III recession defect were included. Patients were randomly assigned to either control (CTG) or OrACELL™ (test) groups, which were treated with identical surgical techniques. All root coverage clinical parameters were evaluated at baseline, 3-, and 6-months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be between 18 and 80 years old, with recession present in one quadrant as either single or multiple buccal vertical recession sites
- •The defect must be at least 2mm in length, (measured from the CEJ to the midfacial gingival margin) and classified as either Miller Class I, II or III
- •Study is limited to vital and nonvital incisors, canines, and premolars
- •If teeth adjacent to the site to be treated had recession as well, they were included in the grafting procedure but not included in measurement
- •Plaque control defined as modified O'Leary Index of 85% was established before surgical intervention
- •Only sites with probing depths of 3mm or less and no bleeding on probing were accepted for surgery
排除标准
- •Subjects who smoke more than ten cigarettes per day or use nicotine replacement therapy
- •History of previous history of surgery performed at surgical sites included in study
- •Subjects who have uncontrolled or poorly controlled systemic conditions that could compromise or contraindicate periodontal surgery
- •Non-English speakers
- •Pregnant or lactating females
- •Immunosuppressant medications
研究组 & 干预措施
Connective Tissue Graft
Connective Tissue is harvested from the palate of the subject then placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the connective tissue graft and the recession.
干预措施: Connective Tissue Graft (Device)
OrACELL
Allograft Tissue (human dermis) is removed from packing and placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the OrACELL graft and the recession.
干预措施: OrACELL (Device)
结局指标
主要结局
Gingival Recession (Root Coverage)
时间窗: 6 months
The measurement in millimeters of the relationship of the cementoenamel junction (CEJ) to the gingival margin
次要结局
未报告次要终点