NCT03664401

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Kerecis Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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

Conditions

• Mucogingival Deformity - Insufficient Keratinized Tissue

Interventions

Type	Name	Description
DEVICE	Kerecis Oral™
OTHER	Free Gingival Graft	A free gingival autograft from patient palate placed and secured on wound bed

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2018-09-10
• Last updated: 2018-09-13

Regulatory

• FDA-regulated drug study
• FDA-regulated device study