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)

Study Overview

• Status: Completed
• Conditions: Mucogingival Deformity - Insufficient Keratinized Tissue
• Intervention / Treatment: Device: Kerecis Oral™; Other: Free Gingival Graft

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

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Kerecis Oral™; The Fish Skin Graft will be is cut to shape of wound bed and placed directly on the appropriate prepared recipient wound bed. The Fish skin graft has the smooth side down and the scaly side facing out. The graft will be sutured in place at either coronal end with resorbable sutures and may be secured apically if needed. A surgical dressing (Coe-Pak® ) will be placed over the graft if needed.	Device: Kerecis Oral™; Other Names: Acellular Fish Skin Graft
ACTIVE_COMPARATOR: Autogenous Free Gingival Graft; The recipient bed will be prepared at the appropriate sequential time as described. The graft will be harvested from the same side that the Free Gingival Graft is to be placed. A measurement will be made to determine the size of the donor tissue needed to be placed at the recipient site. Local anesthetic will be administered. The donor tissue will be harvested using the usual techniques. The width will be 5 mm and the length will match the predetermined measurement. The graft will be thinned as is usual practice. The harvested palatal graft will be centered on the study tooth and placed on the appropriately prepared recipient wound bed. The graft will be sutured with resorbable sutures on the mesial and distal aspects of the tooth. A surgical dressing (Coe-Pak® ) will be placed over the graft if needed.	Other: Free Gingival Graft; A free gingival autograft from patient palate placed and secured on wound bed; Other Names: FGG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in KT width from time of surgery to 3 months post-surgery	Increase in KT Width in MM	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth	mm	3 months
Papillary height and widht	mm	3 months
Horizontal recession	mm	3 months
Subject completed discomfort questionaire	Standard questionare	3 months
Bleeding on probing	Y/N	3 months

Collaborators and Investigators

• Sponsor: Kerecis Ltd.
• Collaborators: Tufts University School of Dental Medicine
• Investigators: Study Chair: Nadeem Karimbux, DMD, MMSc, Tufts University of Dental Medicine

Publications and helpful links

Helpful Links

• One year outcomes of a piscine soft tissue alternative used in mucogingival procedures: a clinical report

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (ACTUAL): September 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 01-GING-001-Kerecis Oral

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No