NCT04703738

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Geistlich Pharma AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Soft Tissue Defect

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-13
• Primary completion: 2021-06-21
• Completion: 2025-12-01
• First posted: 2021-01-11
• Last updated: 2021-12-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study