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

Soft Tissue Defect Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Soft Tissue Defect

• NCT number: NCT04703738
• Study type: Interventional
• Source: Geistlich Pharma AG
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 13, 2018
• Completion date: December 2025