CompletedEarly Phase 1

A Clinical Trial to Evaluate Kerecis Oral™ Compared to Autogenous Free Gingival Graft (AFGG) Tissue to Augment Gingival Soft Tissue and Wound Healing

6 participantsStarted 2016-09-01

Plain-language summary

The purpose of this study is to evaluate Omega-3 Wound™ as an alternative to autogenous free gingival grafts harvested from the palate to treat human subjects with insufficient KT (\< 2 mm)

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age must be at least 18 years but no more than 70 years.
✓. There must be at least two non-adjacent teeth in contralateral sides of the same jaw with an insufficient zone (≤ 2mm) of Keratinized gingiva that requires soft tissue grafting. (1-4 teeth may be treated). If adjacent teeth require grafting, only a single chosen tooth at each site will act as the test or control site, all teeth will however get the same treatment).
✓. The goal of grafting will not be root coverage.
✓. Females must have a documented negative urine pregnancy test if they are of childbearing potential.
✓. All subjects must have read, understood and signed an Informed Consent Form (approved by the institutional review board (IRB)).
✓. All subjects must be willing and able to follow study instructions and protocols.

Exclusion criteria

✕. Any subject that has class III/IV recession with a shallow vestibule.
✕. Any subject that has a vestibule depth of less than 7mm from the base of recession.
✕. Any subjects with systemic conditions (i.e., diabetes mellitus, HIV, cancer, bone metabolic diseases) that typically precludes periodontal surgery.
✕. Any subjects who are currently taking/received or have taken/received within two months prior to study entry, systemic corticosteroids, immunosupressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery. Any subjects taking intramuscular or intravenous bisphosphonates.
✕. Any subjects with any acute lesions in the areas intended for surgery/or with a history of aphthous ulcers.
✕. Any subjects who currently smoke.
✕. Any subject with molar teeth that require treatment at the time of surgery.
✕. Any subjects with teeth with Miller Grade =\>2 mobility.

What they're measuring

Change in KT width from time of surgery to 3 months post-surgery

Timeframe: 3 months

Trial details

NCT IDNCT03664401

SponsorKerecis Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09-01

View on ClinicalTrials.gov More Mucogingival Deformity - Insufficient Keratinized Tissue trials