Trials Sponsors Conditions Drugs Pricing

Conditions

Mucogingival Deformity - Insufficient Keratinized Tissue

Outcome Measures

Primary Outcomes (1)

Change in KT width from time of surgery to 3 months post-surgery
Increase in KT Width in MM
3 months

Secondary Outcomes (5)

Probing depth
3 months
Papillary height and widht
3 months
Horizontal recession
3 months
Subject completed discomfort questionaire
3 months
Bleeding on probing
3 months

Study Arms (2)

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.

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.

Interventions

Kerecis Oral™Device

Also known as: Acellular Fish Skin Graft

Kerecis Oral™

Free Gingival GraftOther

A free gingival autograft from patient palate placed and secured on wound bed

Also known as: FGG

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

Sponsors & Collaborators

Kerecis Ltd.
Industrylead
Tufts University School of Dental Medicine
Othercollaborator

Study Officials

Nadeem Karimbux, DMD, MMSc
Tufts University of Dental Medicine
STUDY CHAIR

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: DEVICE FEASIBILITY
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 10, 2018

Study Start

September 1, 2016

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Kerecis Oral™

Autogenous Free Gingival Graft

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Kerecis Oral™

Autogenous Free Gingival Graft

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record