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

NCT04260152 | Completed FDA Device

• 1 other identifier: 10808-121
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Gingival Recession

Keywords

Gingival Recession; Fibro-Gide; CAF; CTG; Geistlich

Outcome Measures

Primary Outcomes (1)

• Change in percent root coverage

  Change in percent root coverage compared to baseline

  6 months post-treatment

Secondary Outcomes (10)

• 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

• General Periodontal Examination (GPE)

  baseline (day 0) and 6 months; 1, 3, 5 years post-treatment

• Assessment of Wound Healing

  1, 2, 4, 12 weeks post-treatment

• Assessment of Wound Healing

  1, 2, 4, 12 weeks post-treatment

• Assessment of Wound Healing

  1, 2, 4, 12 weeks post-treatment

Study Arms (2)

Control: CAF + CTG

ACTIVE COMPARATOR

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.

Procedure: Connective Tissue Graft (CTG

Test: CAF + Geistlich Fibro-Gide® (test)

EXPERIMENTAL

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.

Device: Geistlich Fibro-Gide

Interventions

Geistlich Fibro-Gide DEVICE

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

Also known as: Coronally advanced Flap (surgery/ procedure)

Test: CAF + Geistlich Fibro-Gide® (test)

Connective Tissue Graft (CTG PROCEDURE

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

Also known as: Coronally advanced Flap (surgery/ procedure)

Control: CAF + CTG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Geistlich Pharma AG: lead
• Medelis Inc.: collaborator

Study Sites (3)

Seven Lakes Periodontitis

Fenton, Michigan, 99999, United States

Location

Perio Health Professionals

Houston, Texas, 77063, United States

Location

Oral Health Specialists

Tacoma, Washington, 99999, United States

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Michael K McGuire, DDS MSD

  PerioHealth Professionals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind (Outcomes Examiner, Subject)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split-mouth, randomized

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: February 7, 2020
• Study Start: September 1, 2018
• Primary Completion: January 4, 2020
• Study Completion: July 22, 2020
• Last Updated: August 10, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)