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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 21, 2021

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Control
    • Soft tissue flap + Connective Tissue Graft
  • Experimental: Test
    • Soft tissue flap + Geistlich Fibro-Gide®

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • All Adverse Events, serious and non serious
    • Time Frame: Day 0, after 2, 4, 12weeks, 6 Months, 1,3,5 Years
    • Recording and Assessment of all (S)AEs starting from Visit 2 onwards, Surgery
  • Post-OP Patient Reported Outcome Questionnaire
    • Time Frame: 6 Months, 1,3,5 Years
    • 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.
  • Concomitant medication
    • Time Frame: 2,4,12 weeks, 6 months, 1,3,5 Years
    • Concomitant medication review compared with Visit 1 and 2
  • Change in gingival soft tissue contour
    • Time Frame: 3 months, 1,3, 5 Years
    • soft tissue contour measured digitally ( 3D-scan) and compared with baseline
  • General Periodontal Examination (GPE)
    • Time Frame: 4, 12 weeks, 6 Months, 1,3,5 Years
    • Changes of GPE at various visits compared to baseline,
  • Pink esthetic score (PES)
    • Time Frame: 6 Months, 1,3,5 Years
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Geistlich Pharma AG
  • Collaborator
    • Medelis Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Donald S Clem III, DDS, Principal Investigator, Regenative Solutions

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.