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Evaluation of Geistlich Fibro-Gide® in Comparison to CTG for the Treatment Around Implants
Sponsor: Geistlich Pharma AG
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2018-08-13
Completion Date
2026-05-12
Last Updated
2026-09-09
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (5)
Regenerative Solutions
Fullerton, California, United States
McClain Schallhorn Periodonitcs
Aurora, Colorado, United States
Perio Health Professionals
Houston, Texas, United States
Periodontal and Dental Implant Surgical Specialist
Virginia City, Virginia, United States
Santarelli Oral and Facial Surgery
Kenosha, Wisconsin, United States