Evaluation of Geistlich Fibro-Gide® + CAF in Comparison to CTG + CAF for the Treatment of Recession Defects at 6 Months
- Conditions
- Gingival Recession
- Interventions
- Device: Geistlich Fibro-GideProcedure: Connective Tissue Graft (CTG
- 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
- Arm && Interventions
Group Intervention Description Test: CAF + Geistlich Fibro-Gide® (test) Geistlich Fibro-Gide 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. Control: CAF + CTG Connective Tissue Graft (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.
- 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)
Oral Health Specialists
🇺🇸Tacoma, Washington, United States
Perio Health Professionals
🇺🇸Houston, Texas, United States
Seven Lakes Periodontitis
🇺🇸Fenton, Michigan, United States