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

Gingival Recession Clinical Trial

— GFG-US-REC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260152
• Other study ID #: 10808-121
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: July 22, 2020

Study information

• Verified date: March 2020
• Source: Geistlich Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 22, 2020
• Est. primary completion date: January 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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

Procedure:
• Connective Tissue Graft (CTG
Surgical recession root coverage with coronally advanced flap in combination with CTG

Locations

Country	Name	City	State
United States	Seven Lakes Periodontitis	Fenton	Michigan
United States	Perio Health Professionals	Houston	Texas
United States	Oral Health Specialists	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Geistlich Pharma AG	Medelis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percent root coverage	Change in percent root coverage compared to baseline	6 months post-treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall Duration of Treatment Surgery	Interval from surgery start until surgery end in Hours/Minutes	2-6 hours at day of surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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