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

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:

• 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)
• Time of surgery
• Subject Discomfort Survey during healing and at 1 week and 4 weeks
• Subject Preference Questionnaire at month 6
• Safety endpoints assessed by monitoring adverse events

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.
• Any patients with known hypersensitivity to bovine collagen and/or iodine (shellfish allergy).
• Any subjects who have received an investigational drug or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental).
• Any subjects previously treated with any allografts at the target site(s) or immediately adjacent teeth.
• Any subjects who will not be able to complete the study per protocol.