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

NAActive, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 13, 2018

Primary Completion Date

June 21, 2021

Study Completion Date

December 31, 2025

Conditions
Soft Tissue Defect
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.

Trial Locations (5)

23226

Periodontal and Dental Implant Surgical Specialist, Virginia Beach

53144

Santarelli Oral and Facial Surgery, Kenosha

77063

Perio Health Professionals, Houston

92835

Regenerative Solutions, Fullerton

80012-3202

McClain Schallhorn Periodonitcs, Aurora

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medelis Inc.

INDUSTRY

lead

Geistlich Pharma AG

INDUSTRY

NCT04703738 - Evaluation of Geistlich Fibro-Gide® in Comparison to CTG for the Treatment Around Implants | Biotech Hunter | Biotech Hunter