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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Connective Tissue Graft (CTG; Device: Geistlich Fibro-Gide

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Fenton, Michigan, United States, 99999
      • Seven Lakes Periodontitis
  • Texas
    • Houston, Texas, United States, 77063
      • Perio Health Professionals
  • Washington
    • Tacoma, Washington, United States, 99999
      • Oral Health Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Connective Tissue Graft (CTG; Surgical recession root coverage with coronally advanced flap in combination with CTG; Other Names: Coronally advanced Flap (surgery/ procedure)
Experimental: 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.	Device: Geistlich Fibro-Gide; Surgical recession root coverage with coronally advanced flap in combination with Geistlich Fibro-Gide; Other Names: Coronally advanced Flap (surgery/ procedure)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percent root coverage	Change in percent root coverage compared to baseline	6 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoints: number and frequency of (S)AEs over all and by organ class	Assessment of (S)AEs starting at Visit 2, Surgery	1, 2, 4, 7, 12 and 24 weeks and year 1,3 and 5 post treatment
General Periodontal Examination (GPE)	change of GPE at various visits compared to baseline, scoring codes 0-4	baseline (day 0) and 6 months; 1, 3, 5 years post-treatment
Assessment of Wound Healing	Judgement of soft tissue wound healing after surgery at Visits 3-6; Primary complete wound closure? yes = complete/ no = dehiscence visible	1, 2, 4, 12 weeks post-treatment
Assessment of Wound Healing	Judgement of soft tissue wound healing after surgery at Visits 3-6; if dehiscence visible, dehiscence size: lenght and width in mm	1, 2, 4, 12 weeks post-treatment
Assessment of Wound Healing	Judgement of soft tissue wound healing after surgery at Visits 3-6; presence of Swelling (yes/ no),	1, 2, 4, 12 weeks post-treatment
Overall Duration of Treatment Surgery	Interval from surgery start until surgery end in Hours/Minutes	2-6 hours at day of surgery
Patient Reported Outcome (PRO) -Patient Diary: Discomfort	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,	7 days after surgery starting 1 day after surgery
Patient Reported Outcome (PRO) -Questionnaire: Esthetics	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,	6 months, 1, 3, 5 years post-treatment
Patient Reported Outcome (PRO) -Questionnaire: for surgical preference	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	1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment
Safety endpoints: Concomitant Medication	Use of Concomitant medication Review: Type of concomitant Medication used.	1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment

Collaborators and Investigators

• Sponsor: Geistlich Pharma AG
• Collaborators: Medelis Inc.
• Investigators: Principal Investigator: Michael K McGuire, DDS MSD, PerioHealth Professionals

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): January 4, 2020
• Study Completion (Actual): July 22, 2020

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Gingival Recession; CAF; Fibro-Gide; CTG; Geistlich
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 10808-121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No