Mucogingival Deformity - Insufficient Keratinized TissueEarly Phase 1NCT03664401
A Clinical Trial to Evaluate Kerecis Oral™ Compared to Autogenous Free Gingival Graft (AFGG) Tissue to Augment Gingival Soft Tissue and Wound Healing
A Early Phase 1 study testing Kerecis Oral™ and Free Gingival Graft in people with Mucogingival Deformity - Insufficient Keratinized Tissue, run by Kerecis Ltd..
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mucogingival Deformity - Insufficient Keratinized Tissue
- What is being tested?
- Kerecis Oral™ and Free Gingival Graft
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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)
Read the 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
- Being tested
- Kerecis Oral™, Free Gingival Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kerecis Oral™Device
Also called Acellular Fish Skin Graft
Free Gingival GraftOther
Also called FGG
A free gingival autograft from patient palate placed and secured on wound bed
| Study group | Role | What they receive |
|---|---|---|
| Kerecis Oral™ | Experimental | 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. Receives: Device: Kerecis Oral™ |
| Autogenous Free Gingival Graft | Active comparator | 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. Receives: Other: Free Gingival Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in KT width from time of surgery to 3 months post-surgery
Increase in KT Width in MM
Measured: 3 months
Secondary outcomes (5)
Probing depth
mm
Measured: 3 months
Papillary height and widht
mm
Measured: 3 months
Horizontal recession
mm
Measured: 3 months
Subject completed discomfort questionaire
Standard questionare
Measured: 3 months
Bleeding on probing
Y/N
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Sep 2016
- Primary completion1 Sep 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucogingival Deformity - Insufficient Keratinized TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized controlled, split mouth (within subject) non-inferiority, single-center trial.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerecis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tufts University School of Dental Medicine
- Responsible party
- Sponsor
- Investigators
- Nadeem Karimbux, DMD, MMSc, Study chair, Tufts University of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664401
- Sponsor's protocol ID
- 01-GING-001-Kerecis Oral
- Status last verified
- Sep 2018
- First submitted
- 30 Aug 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03664401
- Acronym / sponsor ID
- 01-GING-001-Kerecis Oral
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Kerecis Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tufts University School of Dental Medicine
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized controlled, split mouth (within subject) non-inferiority, single-center trial.
| Arm | Type | Receives |
|---|---|---|
| Kerecis Oral™ | Experimental | Device: 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. |
| Autogenous Free Gingival Graft | Active comparator | Other: Free Gingival GraftThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kerecis Oral™Also: Acellular Fish Skin Graft | Device | Kerecis Oral™ |
| Free Gingival GraftAlso: FGGA free gingival autograft from patient palate placed and secured on wound bed | Other | Autogenous Free Gingival Graft |
Primary outcome
Change in KT width from time of surgery to 3 months post-surgery
Time frame: 3 months
Increase in KT Width in MM
5 secondary outcomes
Probing depth
Time frame: 3 months
Papillary height and widht
Time frame: 3 months
Horizontal recession
Time frame: 3 months
Subject completed discomfort questionaire
Time frame: 3 months
Bleeding on probing
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Individual participant dataSharing planned: No
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadeem Karimbux, DMD, MMSc study chair
Tufts University of Dental Medicine
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Kerecis Oral™ and Free Gingival Graft in people with Mucogingival Deformity - Insufficient Keratinized Tissue, run by Kerecis Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in KT width from time of surgery to 3 months post-surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.