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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
6
A free gingival autograft from patient palate placed and secured on wound bed
Change in KT width from time of surgery to 3 months post-surgery
Increase in KT Width in MM
Time frame: 3 months
Probing depth
mm
Time frame: 3 months
Papillary height and widht
mm
Time frame: 3 months
Horizontal recession
mm
Time frame: 3 months
Subject completed discomfort questionaire
Standard questionare
Time frame: 3 months
Bleeding on probing
Y/N
Time frame: 3 months
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