Back to resultsA Clinical Trial to Evaluate Kerecis Oral™ Compared to Autogenous Free Gingival Graft (AFGG) Tissue to Augment Gingival Soft Tissue and Wound Healing
Primary Purpose
Mucogingival Deformity - Insufficient Keratinized Tissue
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Kerecis Oral™
Free Gingival Graft
Sponsored by
About this trial
This is an interventional device feasibility trial for Mucogingival Deformity - Insufficient Keratinized Tissue
Eligibility Criteria
Inclusion Criteria:
- Age must be at least 18 years but no more than 70 years.
- 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).
- The goal of grafting will not be root coverage.
- Females must have a documented negative urine pregnancy test if they are of childbearing potential.
- All subjects must have read, understood and signed an Informed Consent Form (approved by the institutional review board (IRB)).
- All subjects must be willing and able to follow study instructions and protocols.
Exclusion Criteria:
- Any subject that has class III/IV recession with a shallow vestibule.
- Any subject that has a vestibule depth of less than 7mm from the base of recession.
- Any subjects with systemic conditions (i.e., diabetes mellitus, HIV, cancer, bone metabolic diseases) that typically precludes periodontal surgery.
- 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.
- Any subjects with any acute lesions in the areas intended for surgery/or with a history of aphthous ulcers.
- Any subjects who currently smoke.
- Any subject with molar teeth that require treatment at the time of surgery.
- Any subjects with teeth with Miller Grade =>2 mobility.
- Any patients with known hypersensitivity to bovine collagen and/or iodine (shellfish allergy).
- Any subjects who have received an investigational drug or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental).
- Any subjects previously treated with any allografts at the target site(s) or immediately adjacent teeth.
- Any subjects who will not be able to complete the study per protocol.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Kerecis Oral™
Autogenous Free Gingival Graft
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in KT width from time of surgery to 3 months post-surgery
Increase in KT Width in MM
Secondary Outcome Measures
Probing depth
mm
Papillary height and widht
mm
Horizontal recession
mm
Subject completed discomfort questionaire
Standard questionare
Bleeding on probing
Y/N
Full Information
NCT ID
NCT03664401
First Posted
August 30, 2018
Last Updated
September 11, 2018
Sponsor
Kerecis Ltd.
Collaborators
Tufts University School of Dental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03664401
Brief Title
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
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kerecis Ltd.
Collaborators
Tufts University School of Dental Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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:
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)
Time of surgery
Subject Discomfort Survey during healing and at 1 week and 4 weeks
Subject Preference Questionnaire at month 6
Safety endpoints assessed by monitoring adverse events
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucogingival Deformity - Insufficient Keratinized Tissue
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized controlled, split mouth (within subject) non-inferiority, single-center trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kerecis Oral™
Arm Type
Experimental
Arm Description
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.
Arm Title
Autogenous Free Gingival Graft
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Kerecis Oral™
Other Intervention Name(s)
Acellular Fish Skin Graft
Intervention Type
Other
Intervention Name(s)
Free Gingival Graft
Other Intervention Name(s)
FGG
Intervention Description
A free gingival autograft from patient palate placed and secured on wound bed
Primary Outcome Measure Information:
Title
Change in KT width from time of surgery to 3 months post-surgery
Description
Increase in KT Width in MM
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Probing depth
Description
mm
Time Frame
3 months
Title
Papillary height and widht
Description
mm
Time Frame
3 months
Title
Horizontal recession
Description
mm
Time Frame
3 months
Title
Subject completed discomfort questionaire
Description
Standard questionare
Time Frame
3 months
Title
Bleeding on probing
Description
Y/N
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age must be at least 18 years but no more than 70 years.
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).
The goal of grafting will not be root coverage.
Females must have a documented negative urine pregnancy test if they are of childbearing potential.
All subjects must have read, understood and signed an Informed Consent Form (approved by the institutional review board (IRB)).
All subjects must be willing and able to follow study instructions and protocols.
Exclusion Criteria:
Any subject that has class III/IV recession with a shallow vestibule.
Any subject that has a vestibule depth of less than 7mm from the base of recession.
Any subjects with systemic conditions (i.e., diabetes mellitus, HIV, cancer, bone metabolic diseases) that typically precludes periodontal surgery.
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.
Any subjects with any acute lesions in the areas intended for surgery/or with a history of aphthous ulcers.
Any subjects who currently smoke.
Any subject with molar teeth that require treatment at the time of surgery.
Any subjects with teeth with Miller Grade =>2 mobility.
Any patients with known hypersensitivity to bovine collagen and/or iodine (shellfish allergy).
Any subjects who have received an investigational drug or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental).
Any subjects previously treated with any allografts at the target site(s) or immediately adjacent teeth.
Any subjects who will not be able to complete the study per protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadeem Karimbux, DMD, MMSc
Organizational Affiliation
Tufts University of Dental Medicine
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Trial to Evaluate Kerecis Oral™ Compared to Autogenous Free Gingival Graft (AFGG) Tissue to Augment Gingival Soft Tissue and Wound Healing
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