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
NCT ID NCT04703738
First seen Sep 09, 2026 · Last updated Sep 09, 2026
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
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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60 people
The number who actually took part.
- Started
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Aug 2018
- Finished
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May 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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McClain Schallhorn Periodonitcs
Aurora, Colorado, 80012-3202, United States
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Perio Health Professionals
Houston, Texas, 77063, United States
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Periodontal and Dental Implant Surgical Specialist
Virginia City, Virginia, 23226, United States
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Regenerative Solutions
Fullerton, California, 92835, United States
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Santarelli Oral and Facial Surgery
Kenosha, Wisconsin, 53144, United States
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