Gingival Recession
Conditions
Keywords
Gingival Recession, Fibro-Gide, CAF, CTG, Geistlich
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.
Interventions
DEVICEGeistlich Fibro-Gide
Surgical recession root coverage with coronally advanced flap in combination with Geistlich Fibro-Gide
PROCEDUREConnective Tissue Graft (CTG
Surgical recession root coverage with coronally advanced flap in combination with CTG
Sponsors
Medelis Inc.
Geistlich Pharma AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double-blind (Outcomes Examiner, Subject)
Intervention model description
Split-mouth, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in percent root coverage | 6 months post-treatment | Change in percent root coverage compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Assessment of Wound Healing | 1, 2, 4, 12 weeks post-treatment | Judgement of soft tissue wound healing after surgery at Visits 3-6; Primary complete wound closure? yes = complete/ no = dehiscence visible |
| Overall Duration of Treatment Surgery | 2-6 hours at day of surgery | Interval from surgery start until surgery end in Hours/Minutes |
| 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 |
| 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, |
| 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 |
| 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. |
| 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, |
Countries
United States
Outcome results
None listed