Evaluation of Geistlich Fibro-Gide® + CAF in Comparison to CTG + CAF for the Treatment of Recession Defects at 6 Months

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

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.

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.

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.