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

2018-09-14 03:31:18 | BioPortfolio


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)


Primary objective:

The primary aim will be to see if Omega-3 Wound™ is clinically superior to tissue harvested from the palate (Autogenous Free Gingival Graft) when comparing before and after measurements of: keratinized tissue. Change in KT width from time of surgery to 6 months post-surgery (22).

Secondary objectives:

1. Measures of periodontal health (probing depth, recession levels, bleeding on probing, plaque score, clinical attachment level, resistance to muscle pull, vestibular depth, healing time) over 3 months (at study entry, 4 weeks, 3 months and 6 months)

2. Time of surgery

3. Subject Discomfort Survey during healing and at 1 week and 4 weeks

4. Subject Preference Questionnaire at month 6

5. Safety endpoints assessed by monitoring adverse events

Study Design


Mucogingival Deformity - Insufficient Keratinized Tissue


Kerecis Oral™, Free Gingival Graft




Kerecis Ltd.

Results (where available)

View Results


Published on BioPortfolio: 2018-09-14T03:31:18-0400

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