Status:
UNKNOWN
Evaluation of Geistlich Fibro-Gide® in Comparison to CTG for the Treatment Around Implants
Lead Sponsor:
Geistlich Pharma AG
Collaborating Sponsors:
Medelis Inc.
Conditions:
Soft Tissue Defect
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04703738
Start Date
August 13 2018
End Date
December 1 2025
Last Update
December 15 2021
Active Locations (5)
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1
Regenerative Solutions
Fullerton, California, United States, 92835
2
McClain Schallhorn Periodonitcs
Aurora, Colorado, United States, 80012-3202
3
Perio Health Professionals
Houston, Texas, United States, 77063
4
Periodontal and Dental Implant Surgical Specialist
Virginia Beach, Virginia, United States, 23226