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COMPLETED
NCT04703738
NA

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

Sponsor: Geistlich Pharma AG

View on ClinicalTrials.gov

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

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.

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