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

NCT04703738 | Unknown FDA Device

• 1 other identifier: 10808-122
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Soft Tissue Defect

Keywords

soft tissue augmentation; soft tissue volume; Fibro-Gide; CTG; Geistlich

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• All Adverse Events, serious and non serious

  Day 0, after 2, 4, 12weeks, 6 Months, 1,3,5 Years

• Post-OP Patient Reported Outcome Questionnaire

  6 Months, 1,3,5 Years

• Concomitant medication

  2,4,12 weeks, 6 months, 1,3,5 Years

• Change in gingival soft tissue contour

  3 months, 1,3, 5 Years

• General Periodontal Examination (GPE)

  4, 12 weeks, 6 Months, 1,3,5 Years

Study Arms (2)

Control

ACTIVE COMPARATOR

Soft tissue flap + Connective Tissue Graft

Procedure: Soft tissue flap + Connective Tissue Graft

Test

EXPERIMENTAL

Soft tissue flap + Geistlich Fibro-Gide®

Device: Soft tissue flap + Geistlich Fibro-Gide®

Interventions

Soft tissue flap + Connective Tissue Graft PROCEDURE

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.

Control

Soft tissue flap + Geistlich Fibro-Gide® DEVICE

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.

Test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Geistlich Pharma AG: lead
• Medelis Inc.: collaborator

Study Sites (5)

Regenerative Solutions

Fullerton, California, 92835, United States

Location

McClain Schallhorn Periodonitcs

Aurora, Colorado, 80012-3202, United States

Location

Perio Health Professionals

Houston, Texas, 77063, United States

Location

Periodontal and Dental Implant Surgical Specialist

Virginia Beach, Virginia, 23226, United States

Location

Santarelli Oral and Facial Surgery

Kenosha, Wisconsin, 53144, United States

Location

Study Officials

• Donald S Clem III, DDS

  Regenative Solutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind (Outcomes Examiner)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: parallel, randomized, controlled, single-blind, multi-centre clinical trial

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: January 11, 2021
• Study Start: August 13, 2018
• Primary Completion: June 21, 2021
• Study Completion: December 1, 2025
• Last Updated: December 15, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)