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Completed
NCT04703738
Evaluation of Geistlich Fibro-Gide® in Comparison to CTG for the Treatment Around Implants
Conditions: Soft Tissue Defect
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Geistlich Pharma AG
Location: Regenerative Solutions Fullerton California
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
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT04703738). StuddyBuddy aggregates publicly available trial information.