Clinical trial NCT04260152: Evaluation of Geistlich Fibro-Gide® + CAF in Comparison to CTG + CAF for the Treatment of Recession Defects at 6 Months
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: Gingival Recession
Fibro-Gide
CAF
CTG
Geistlich
Lead sponsor: Geistlich Pharma AG
Sponsor class: INDUSTRY
Collaborators: name: Medelis Inc.
First posted: 2020-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth, randomized
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in percent root coverage
timeFrame: 6 months post-treatment
Secondary outcomes:
measure: Safety Endpoints: number and frequency of (S)AEs over all and by organ class
timeFrame: 1, 2, 4, 7, 12 and 24 weeks and year 1,3 and 5 post treatment
measure: General Periodontal Examination (GPE)
timeFrame: baseline (day 0) and 6 months; 1, 3, 5 years post-treatment
measure: Assessment of Wound Healing
timeFrame: 1, 2, 4, 12 weeks post-treatment
measure: Assessment of Wound Healing
timeFrame: 1, 2, 4, 12 weeks post-treatment
measure: Assessment of Wound Healing
timeFrame: 1, 2, 4, 12 weeks post-treatment
measure: Overall Duration of Treatment Surgery
timeFrame: 2-6 hours at day of surgery
measure: Patient Reported Outcome (PRO) -Patient Diary: Discomfort
timeFrame: 7 days after surgery starting 1 day after surgery
measure: Patient Reported Outcome (PRO) -Questionnaire: Esthetics
timeFrame: 6 months, 1, 3, 5 years post-treatment
measure: Patient Reported Outcome (PRO) -Questionnaire: for surgical preference
timeFrame: 1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment
measure: Safety endpoints: Concomitant Medication
timeFrame: 1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment
Other outcomes:
Locations:
city: Fenton
country: United States
facility: Seven Lakes Periodontitis
state: Michigan
city: Houston
country: United States
facility: Perio Health Professionals
state: Texas
city: Tacoma
country: United States
facility: Oral Health Specialists
state: Washington
Study officials:
affiliation: PerioHealth Professionals
name: Michael K McGuire, DDS MSD
role: PRINCIPAL_INVESTIGATOR
References: