Evaluation of Geistlich Fibro-Gide® in Comparison to CTG for the Treatment Around Implants

A Prospective, Randomized and Controlled Multi-center Study of Geistlich Fibro-Gide® Compared With Connective Tissue Graft for Soft Tissue Volume Augmentation Around Dental Implants

This double blind, randomized, parallel study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for soft tissue volume augmentation around dental implants

Study Overview

• Status: Active, not recruiting
• Conditions: Soft Tissue Defect
• Intervention / Treatment: Procedure: Soft tissue flap + Connective Tissue Graft; Device: Soft tissue flap + Geistlich Fibro-Gide®

Detailed Description

A total sample size of 60 subjects (n=60) will be evaluated at 5 centers, by 6 Investigators with approximately 10-subjects per Investigator. Power analysis based on 80% power, past Thoma, Zeltner and González-Martin studies 1,2,3 and a one-sided confidence interval of 0.025, indicates that with a volume change standard deviation between 0.5 and 0.7 mm, 17-31 subjects are required per group (test and control), so 50-60 subjects are an acceptable estimate, with a preference for 60, given potential loss to long-term follow-up.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fullerton, California, United States, 92835
      • Regenerative Solutions
  • Colorado
    • Aurora, Colorado, United States, 80012-3202
      • McClain Schallhorn Periodonitcs
  • Texas
    • Houston, Texas, United States, 77063
      • Perio Health Professionals
  • Virginia
    • Virginia Beach, Virginia, United States, 23226
      • Periodontal and Dental Implant Surgical Specialist
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Santarelli Oral and Facial Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects requiring soft tissue augmentation around single implants, i.e., thin biotype with potential for
• All implants must be at least 6 months post bone graft/implant placement
• have at least 1 mm of keratinized tissue width (KTw),
• have final restoration permanently in place for at least 4-weeks and
• subject have no recession on the implant body
• Subjects who, can achieve good oral hygiene (80% plaque free surfaces on the implant and maintain 80% plaque free surfaces on teeth adjacent to treatment sites).

Exclusion Criteria:

• participation within the last six months in other interventional studies.
• any systemic condition that could influence healing, such as uncontrolled diabetes mellitus - confirmed by A1C score ≥7% - cancer, HIV, oral muco- cutaneous conditions and drug induced gingival enlargement.
• taking medications that compromise wound healing, such as chronic steroid use - either inhaler or systemic, calcium channel blockers with secondary hyperplastic tissue reactions, anti-seizure medications, IV bisphosphates for bone metabolic diseases, radiation or other immuno-suppressive therapy.
• acute infectious lesions in the areas intended for surgery.
• History within the last 6 months of weekly or more frequent use of nicotine products
• Female subjects 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
• Untreated, moderate to severe periodontal disease.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Soft tissue flap + Connective Tissue Graft	Procedure: Soft tissue flap + Connective Tissue Graft; The treatment site is accessed using a full thickness flap extending at least 1 full tooth mesial and distal, vertical releasing incisions may be used to obtain flap release for full coverage of the treatment site and graft without compression. The harvest graft donor area will be the palate in the bicuspid region on the same side as the control soft tissue augmentation therapy. The CTG will be harvested using full thickness incisions that include the periosteum and will be closed using suture and coating the incision line with a tissue adhesive. No covering stents or packs should be employed. The CTG will be sling sutured in place and the flap secured using a double sling suturing technique.
Experimental: Test; Soft tissue flap + Geistlich Fibro-Gide®	Device: Soft tissue flap + Geistlich Fibro-Gide®; The treatment site is accessed using a full thickness flap extending at least 1 full tooth mesial and distal, vertical releasing incisions may be used to obtain flap release for full coverage of the treatment site and matrix without compression. Geistlich Fibro-Gide® is cut to shape to the treatment site and placed dry into the site. The flap is secured using a double sling suturing technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gingival soft tissue volume assessed with 3D scanning	Change in gingival soft tissue volume compared to baseline [Time Frame 6 months post-treatment] Measured by digital contour scan	6 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Adverse Events, serious and non serious	Recording and Assessment of all (S)AEs starting from Visit 2 onwards, Surgery	Day 0, after 2, 4, 12weeks, 6 Months, 1,3,5 Years
Post-OP Patient Reported Outcome Questionnaire	subjects will answer a questionnaire regarding discomfort, esthetic satisfaction and overall satisfaction questions asked by a 3rd-party rec At Visits 2-weeks, and 1- and 3-months post-operative, subjects will answer discomfort/ pain questions asked by a 3rd-party recorder.	6 Months, 1,3,5 Years
Concomitant medication	Concomitant medication review compared with Visit 1 and 2	2,4,12 weeks, 6 months, 1,3,5 Years
Change in gingival soft tissue contour	soft tissue contour measured digitally ( 3D-scan) and compared with baseline	3 months, 1,3, 5 Years
General Periodontal Examination (GPE)	Changes of GPE at various visits compared to baseline,	4, 12 weeks, 6 Months, 1,3,5 Years
Pink esthetic score (PES)	pink esthetic score evaluates soft tissue around single-tooth implants. The PES is based on seven variables: Mesial papilla, Distal papilla, Soft tissue Level, Soft-tissue contour, Alveolar process deficiency, Soft-tissue Color, Soft tissue texture, 2-1-0 score	6 Months, 1,3,5 Years

Collaborators and Investigators

• Sponsor: Geistlich Pharma AG
• Collaborators: Medelis Inc.
• Investigators: Principal Investigator: Donald S Clem III, DDS, Regenative Solutions

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): June 21, 2021
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: soft tissue augmentation; Fibro-Gide; CTG; Geistlich; soft tissue volume
• Other Study ID Numbers: 10808-122

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