Evaluation of Geistlich Fibro-Gide® + CAF in Comparison to CTG + CAF for the Treatment of Recession Defects at 6 Months
- Conditions
- Gingival Recession
- Registration Number
- NCT04260152
- Lead Sponsor
- Geistlich Pharma AG
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in percent root coverage 6 months post-treatment Change in percent root coverage compared to baseline
- Secondary Outcome Measures
Name Time Method Patient Reported Outcome (PRO) -Questionnaire: for surgical preference 1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment Post-Op PRO questionnaire, Surgival procedure Preference, patients will be asked by a 3rd party recorder, Overall which treatment did you prefer? A or B
Assessment of Wound Healing 1, 2, 4, 12 weeks post-treatment Judgement of soft tissue wound healing after surgery at Visits 3-6; presence of Swelling (yes/ no),
Patient Reported Outcome (PRO) -Patient Diary: Discomfort 7 days after surgery starting 1 day after surgery Post-Op PRO Discomfort Diary completed by Patients at home; scale 0-10, 0=no pain or discomfort at all, 10=as much as you can imagine,
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 Assessment of (S)AEs starting at Visit 2, Surgery
General Periodontal Examination (GPE) baseline (day 0) and 6 months; 1, 3, 5 years post-treatment change of GPE at various visits compared to baseline, scoring codes 0-4
Safety endpoints: Concomitant Medication 1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment Use of Concomitant medication Review: Type of concomitant Medication used.
Overall Duration of Treatment Surgery 2-6 hours at day of surgery Interval from surgery start until surgery end in Hours/Minutes
Patient Reported Outcome (PRO) -Questionnaire: Esthetics 6 months, 1, 3, 5 years post-treatment Post-Op PRO questionnaire, Esthetics and overall satisfaction, patients will be asked by a 3rd party recorder, scale 0-10, 0=not satisfied at all with estehtic appearance, 10=completely satisfied,
Trial Locations
- Locations (3)
Seven Lakes Periodontitis
🇺🇸Fenton, Michigan, United States
Perio Health Professionals
🇺🇸Houston, Texas, United States
Oral Health Specialists
🇺🇸Tacoma, Washington, United States
Seven Lakes Periodontitis🇺🇸Fenton, Michigan, United States