Back to results

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

Primary Purpose

Gingival Recession

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Geistlich Fibro-Gide

Connective Tissue Graft (CTG

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Gingival Recession, Fibro-Gide, CAF, CTG, Geistlich

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Seven Lakes Periodontitis
Perio Health Professionals
Oral Health Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control: CAF + CTG

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in percent root coverage

Change in percent root coverage compared to baseline

Secondary Outcome Measures

Safety Endpoints: number and frequency of (S)AEs over all and by organ class

Assessment of (S)AEs starting at Visit 2, Surgery

General Periodontal Examination (GPE)

change of GPE at various visits compared to baseline, scoring codes 0-4

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

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

Assessment of Wound Healing

Judgement of soft tissue wound healing after surgery at Visits 3-6; presence of Swelling (yes/ no),

Overall Duration of Treatment Surgery

Interval from surgery start until surgery end in Hours/Minutes

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,

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,

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

Safety endpoints: Concomitant Medication

Use of Concomitant medication Review: Type of concomitant Medication used.

Full Information

NCT ID

NCT04260152

First Posted

September 18, 2019

Last Updated

August 9, 2021

Sponsor

Geistlich Pharma AG

Collaborators

Medelis Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04260152

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

January 4, 2020 (Actual)

Study Completion Date

July 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Geistlich Pharma AG

Collaborators

Medelis Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Split-mouth, randomized

Masking

ParticipantOutcomes Assessor

Masking Description

Double-blind (Outcomes Examiner, Subject)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control: CAF + CTG

Arm Type

Active Comparator

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Geistlich Fibro-Gide

Other Intervention Name(s)

Coronally advanced Flap (surgery/ procedure)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Connective Tissue Graft (CTG

Other Intervention Name(s)

Coronally advanced Flap (surgery/ procedure)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in percent root coverage

Description

Change in percent root coverage compared to baseline

Time Frame

6 months post-treatment

Secondary Outcome Measure Information:

Title

Safety Endpoints: number and frequency of (S)AEs over all and by organ class

Description

Assessment of (S)AEs starting at Visit 2, Surgery

Time Frame

1, 2, 4, 7, 12 and 24 weeks and year 1,3 and 5 post treatment

Title

General Periodontal Examination (GPE)

Description

change of GPE at various visits compared to baseline, scoring codes 0-4

Time Frame

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

Title

Assessment of Wound Healing

Description

Judgement of soft tissue wound healing after surgery at Visits 3-6; Primary complete wound closure? yes = complete/ no = dehiscence visible

Time Frame

1, 2, 4, 12 weeks post-treatment

Title

Assessment of Wound Healing

Description

Judgement of soft tissue wound healing after surgery at Visits 3-6; if dehiscence visible, dehiscence size: lenght and width in mm

Time Frame

1, 2, 4, 12 weeks post-treatment

Title

Assessment of Wound Healing

Description

Judgement of soft tissue wound healing after surgery at Visits 3-6; presence of Swelling (yes/ no),

Time Frame

1, 2, 4, 12 weeks post-treatment

Title

Overall Duration of Treatment Surgery

Description

Interval from surgery start until surgery end in Hours/Minutes

Time Frame

2-6 hours at day of surgery

Title

Patient Reported Outcome (PRO) -Patient Diary: Discomfort

Description

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,

Time Frame

7 days after surgery starting 1 day after surgery

Title

Patient Reported Outcome (PRO) -Questionnaire: Esthetics

Description

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,

Time Frame

6 months, 1, 3, 5 years post-treatment

Title

Patient Reported Outcome (PRO) -Questionnaire: for surgical preference

Description

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

Time Frame

1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment

Title

Safety endpoints: Concomitant Medication

Description

Use of Concomitant medication Review: Type of concomitant Medication used.

Time Frame

1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael K McGuire, DDS MSD

Organizational Affiliation

PerioHealth Professionals

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seven Lakes Periodontitis

City

Fenton

State/Province

Michigan

ZIP/Postal Code

99999

Country

United States

Facility Name

Perio Health Professionals

City

Houston

State/Province

Texas

ZIP/Postal Code

77063

Country

United States

Facility Name

Oral Health Specialists

City

Tacoma

State/Province

Washington

ZIP/Postal Code

99999

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs