Mucogingival Deformity - Insufficient Keratinized Tissue Clinical Trial
Official title:
A Clinical Trial to Evaluate Kerecis Oral™ Compared to Autogenous Free Gingival Graft (AFGG) Tissue to Augment Gingival Soft Tissue and Wound Healing
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
;