A Prospective, Randomized, Controlled, Double-blind, Multi-center Study to Assess Non-inferiority of Geistlich Fibro-Gide® in Comparison to Connective Tissue Graft for the Treatment of Recession Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Change in percent root coverage
研究概览
简要总结
This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment.
详细描述
This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment.
A total sample size of 30 subjects (n=30) will be evaluated at 3 centers with 4 investigators. Power analysis based on 80% power and past McGuire/ Scheyer matched-pair defect recession coverage studies, with one-sided confidence interval 0.025, indicates that in order to detect a 12% difference in root coverage with ± 15% standard deviation a patient sample of 25 should be used . Given the multi-center nature of this study and the intention to follow patients long-term, with normal attrition, 30 subjects will ensure adequate long-term follow-up and provide a "power buffer" for any outcome differences that might be seen between centers.
30 Patients with Miller Class I or II recession defects on bilateral sites will be treated randomly with coronally advanced flap (CAF) in combination with either Geistlich Fibro-Gide (GFG =Test) on one side, and Connective Tissue Graft (CTG = Control) on the contralateral side of the mouth. Follow-up visits after visit 2 surgery will be conducted at week 1,2, 4,12 and 24 and in the long term after 1,3 and 5 years.
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)
盲法说明
Double-blind (Outcomes Examiner, Subject)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years of age, inclusive.
- •Subjects must have at least two teeth with buccal Miller Class I or II recession type defects, 3 mm deep and 3 mm wide on the same tooth in the contralateral quadrant of the same jaw
- •Defects should be similar in size and morphology
- •Teeth with root canals should be asymptomatic, completed at least 6 months prior
- •At least 1mm KT
- •Subjects with parafunctional habits must wear a bite guard to be included.
排除标准
- •Participation within the previous 30 days in other investigational clinical trials.
- •Class V restorations or abfractions that obliterate the CEJ.
- •Subjects whose teeth have extremely prominent root surfaces -greater than 2mm facially to the adjacent teeth measured at the level of the CEJ.
- •Systemic conditions that could influence wound healing or any other conditions that would preclude periodontal surgery.
- •Taking medications that compromise wound healing.
- •Acute infectious lesions in the areas intended for surgery.
- •Untreated moderate to severe periodontal disease.
- •Weekly or more frequent use of nicotine products within the past 6 months.
- •Females who are pregnant or lactating, or sexually active female subjects who are of childbearing potential and who are not using hormonal or barrier methods of birth control.
- •Subjects who require sedation in order to undergo surgery.
- •Molars, teeth with axial mobility or interproximal loss of attachment, or full coverage crowns or veneers do not qualify.
结局指标
主要结局
Change in percent root coverage
时间窗: 6 months post-treatment
Change in percent root coverage compared to baseline
次要结局
- Patient Reported Outcome (PRO) -Questionnaire: for surgical preference(1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment)
- Patient Reported Outcome (PRO) -Patient Diary: Discomfort(7 days after surgery starting 1 day after surgery)
- Safety Endpoints: number and frequency of (S)AEs over all and by organ class(1, 2, 4, 7, 12 and 24 weeks and year 1,3 and 5 post treatment)
- General Periodontal Examination (GPE)(baseline (day 0) and 6 months; 1, 3, 5 years post-treatment)
- Safety endpoints: Concomitant Medication(1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment)
- Overall Duration of Treatment Surgery(2-6 hours at day of surgery)
- Patient Reported Outcome (PRO) -Questionnaire: Esthetics(6 months, 1, 3, 5 years post-treatment)
- Assessment of Wound Healing(1, 2, 4, 12 weeks post-treatment)