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

NCT ID: NCT04260152

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-07-22

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.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Connective Tissue Graft (CTG

Intervention Type: PROCEDURE

Surgical recession root coverage with coronally advanced flap in combination with CTG

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.

Group Type: EXPERIMENTAL

Geistlich Fibro-Gide

Intervention Type: DEVICE

Surgical recession root coverage with coronally advanced flap in combination with Geistlich Fibro-Gide

Interventions

Geistlich Fibro-Gide

Surgical recession root coverage with coronally advanced flap in combination with Geistlich Fibro-Gide

Intervention Type: DEVICE

Connective Tissue Graft (CTG

Surgical recession root coverage with coronally advanced flap in combination with CTG

Intervention Type: PROCEDURE

Other Intervention Names

Coronally advanced Flap (surgery/ procedure); Coronally advanced Flap (surgery/ procedure)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medelis Inc.

INDUSTRY

Sponsor Role: collaborator

Geistlich Pharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael K McGuire, DDS MSD

Role: PRINCIPAL_INVESTIGATOR

PerioHealth Professionals

Locations

Seven Lakes Periodontitis

Fenton, Michigan, United States

Perio Health Professionals

Houston, Texas, United States

Oral Health Specialists

Tacoma, Washington, United States

Countries

United States

Other Identifiers

10808-121

Identifier Type: -

Identifier Source: org_study_id