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
- 3
- 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.
研究组 & 干预措施
Control: CAF + CTG
Following root preparation and conditioning, the CTG is obtained from the palate according to the randomization scheme and shaped to the recipient site and may be sutured to the papilla region and the coronally advanced flap (CAF) is sutured into place.
干预措施: Connective Tissue Graft (CTG (Procedure)
Test: CAF + Geistlich Fibro-Gide® (test)
Following root preparation and conditioning, Geistlich Fibro-Gide® is cut to size and shaped to the recipient and may be sutured and the coronally advanced flap (CAF) is sutured into place.
干预措施: Geistlich Fibro-Gide (Device)
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
- Assessment of Wound Healing(1, 2, 4, 12 weeks post-treatment)
- 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)