Clinical trial NCT03664401: A Clinical Trial to Evaluate Kerecis Oral™ Compared to Autogenous Free Gingival Graft (AFGG) Tissue to Augment Gingival Soft Tissue and Wound Healing
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Mucogingival Deformity - Insufficient Keratinized Tissue
Lead sponsor: Kerecis Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Tufts University School of Dental Medicine
First posted: 2018-09-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized controlled, split mouth (within subject) non-inferiority, single-center trial.
Primary purpose: DEVICE_FEASIBILITY

Brief 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

Eligibility criteria: Inclusion Criteria:

1. Age must be at least 18 years but no more than 70 years.
2. 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).
3. The goal of grafting will not be root coverage.
4. Females must have a documented negative urine pregnancy test if they are of childbearing potential.
5. All subjects must have read, understood and signed an Informed Consent Form (approved by the institutional review board (IRB)).
6. All subjects must be willing and able to follow study instructions and protocols.

Exclusion Criteria:

1. Any subject that has class III/IV recession with a shallow vestibule.
2. Any subject that has a vestibule depth of less than 7mm from the base of recession.
3. Any subjects with systemic conditions (i.e., diabetes mellitus, HIV, cancer, bone metabolic diseases) that typically precludes periodontal surgery.
4. 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.
5. Any subjects with any acute lesions in the areas intended for surgery/or with a history of aphthous ulcers.
6. Any subjects who currently smoke.
7. Any subject with molar teeth that require treatment at the time of surgery.
8. Any subjects with teeth with Miller Grade =\>2 mobility.
9. Any patients with known hypersensitivity to bovine collagen and/or iodine (shellfish allergy).
10. Any subjects who have received an investigational drug or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental).
11. Any subjects previously treated with any allografts at the target site(s) or immediately adjacent teeth.
12. Any subjects who will not be able to complete the study per protocol.

Primary outcomes:
measure: Change in KT width from time of surgery to 3 months post-surgery
timeFrame: 3 months
Secondary outcomes:
measure: Probing depth
timeFrame: 3 months
measure: Papillary height and widht
timeFrame: 3 months
measure: Horizontal recession
timeFrame: 3 months
measure: Subject completed discomfort questionaire
timeFrame: 3 months
measure: Bleeding on probing
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Tufts University of Dental Medicine
name: Nadeem Karimbux, DMD, MMSc
role: STUDY_CHAIR
References: