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

Geistlich Pharma

Status

Active, not recruiting

Conditions

Soft Tissue Defect

Treatments

Procedure: Soft tissue flap + Connective Tissue Graft

Device: Soft tissue flap + Geistlich Fibro-Gide®

Study type

Interventional

Funder types

Industry

Identifiers

NCT04703738

10808-122

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects requiring soft tissue augmentation around single implants, i.e., thin biotype with potential for
All implants must be at least 6 months post bone graft/implant placement
have at least 1 mm of keratinized tissue width (KTw),
have final restoration permanently in place for at least 4-weeks and
subject have no recession on the implant body
Subjects who, can achieve good oral hygiene (80% plaque free surfaces on the implant and maintain 80% plaque free surfaces on teeth adjacent to treatment sites).

Exclusion criteria

participation within the last six months in other interventional studies.
any systemic condition that could influence healing, such as uncontrolled diabetes mellitus - confirmed by A1C score ≥7% - cancer, HIV, oral muco- cutaneous conditions and drug induced gingival enlargement.
taking medications that compromise wound healing, such as chronic steroid use - either inhaler or systemic, calcium channel blockers with secondary hyperplastic tissue reactions, anti-seizure medications, IV bisphosphates for bone metabolic diseases, radiation or other immuno-suppressive therapy.
acute infectious lesions in the areas intended for surgery.
History within the last 6 months of weekly or more frequent use of nicotine products
Female subjects who are pregnant or lactating, or sexually active female subjects who are of childbearing potential and who are not using hormonal or barrier methods of birth control
Untreated, moderate to severe periodontal disease.