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

Status unconfirmed · Not applicable

Conditions studied: Soft Tissue Defect

In brief

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

Key facts

Study ID

NCT04703738

Run by

Geistlich Pharma AG

People needed

60

Starts

2018-08-13

Expected to finish

2025-12-01

Last updated by the study team

2021-12-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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 Beach, Virginia, United States
• Santarelli Oral and Facial Surgery — Kenosha, Wisconsin, United States

Full record on ClinicalTrials.gov

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