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Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration

Primary Purpose

Gingival Recession

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Gintuit

Autologous palatal tissue

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is at least 18 years of age but no more than 70 years of age.
Subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw with an insufficient zone (< or = 1mm) of attached gingiva that requires soft tissue grafting. (1-3 teeth may be treated. In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment).
Root coverage is not desired at the time of grafting.
Females of childbearing potential must have a documented negative urine pregnancy test.
Subjects must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form.
Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

Subject with class III recession in the presence of a shallow vestibule or class IV recession.
Subject with vestibule depth of less than 7mm from base of recession.
Subject with any systemic conditions that could compromise wound healing and preclude periodontal surgery (i.e., diabetes mellitus, cancer, human immunodeficiency virus (HIV), bone metabolic diseases).
Subject who is currently receiving or has received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
Subject with the presence of acute infectious lesions in the areas intended for surgery.
Subject who has used any tobacco product within 3 months.
Subject who is taking intramuscular or intravenous bisphosphonates.
Subject with only molar teeth suitable for soft tissue grafting.
Subject with teeth that have Miller Grade 2 or higher mobility.
Subject with known hypersensitivity to bovine collagen and/or iodine (shellfish allergy).
Subject who has received an investigational drug or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental).
Subject who was previously treated with Gintuit, Dermagraft or any other skin graft at the target site(s) or immediately adjacent teeth.
Subject, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Sites / Locations

Nevins Perio, LLC
Michigan Center for Oral Health Research
Perio Health Professionals, PLLC
University of Texas Health Science Center - San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Within-subject design: one side of the mouth receives Gintuit

Within-subject control: one side of mouth receives tissue harvested from the palate

Outcomes

Primary Outcome Measures

Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.

The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.

Secondary Outcome Measures

Color Same as Adjacent Tissues After 6 Months (Superiority)

An examiner assessed color of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as "More Red", "Equally Red", or "Less Red" as compared to adjacent, non-treated tissue. A match in color with the surrounding tissue is considered a positive aesthetic outcome.

Texture Same as Adjacent Tissues After 6 Months (Superiority)

An examiner assessed texture of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as "More Firm", "Equally Firm", or "Less Firm" as compared to adjacent, non-treated tissue. A match in texture with the surrounding tissue is considered a positive aesthetic outcome.

Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.

The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.

Patient Preference After 6 Months/Early Termination (Superiority)

Number of patients expressing preference for Gintuit.

Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)

The sensitivity of Gintuit, Free Gingival Graft (FGG) and palatal donation sites was assessed with a puff of air and rated by the Investigator as none, mild, moderate or severe sensitivity. The sensitivity of Control was determined as the most sensitive of FGG and palatal donation sites.

Pain Absent After 3 Days (Superiority)

Pain Assessment(Modified Intent-to-Treat Population)

Full Information

NCT ID

NCT00587834

First Posted

December 21, 2007

Last Updated

October 9, 2012

Sponsor

Organogenesis

1. Study Identification

Unique Protocol Identification Number

NCT00587834

Brief Title

Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration

Official Title

A Clinical Trial to Evaluate Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) as an Alternative to Tissue From the Palate to Enhance Oral Soft Tissue Regeneration and Wound Healing

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organogenesis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate Gintuit as a safe and effective alternative to palatal tissue in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingiva associated with at least two nonadjacent teeth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Within-subject design: one side of the mouth receives Gintuit

Arm Title

Arm Type

Active Comparator

Arm Description

Within-subject control: one side of mouth receives tissue harvested from the palate

Intervention Type

Device

Intervention Name(s)

Gintuit

Intervention Description

Application of Gintuit at Day 0 to the gingival bed

Intervention Type

Other

Intervention Name(s)

Autologous palatal tissue

Intervention Description

Tissue will be harvested from the subject's palate and placed on the gingival bed

Primary Outcome Measure Information:

Title

Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.

Description

The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Color Same as Adjacent Tissues After 6 Months (Superiority)

Description

Time Frame

6 months

Title

Texture Same as Adjacent Tissues After 6 Months (Superiority)

Description

Time Frame

6 months

Title

Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.

Description

The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.

Time Frame

6 months

Title

Patient Preference After 6 Months/Early Termination (Superiority)

Description

Number of patients expressing preference for Gintuit.

Time Frame

6 months

Title

Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)

Description

Time Frame

6 months

Title

Pain Absent After 3 Days (Superiority)

Description

Pain Assessment(Modified Intent-to-Treat Population)

Time Frame

Day 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is at least 18 years of age but no more than 70 years of age. Subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw with an insufficient zone (< or = 1mm) of attached gingiva that requires soft tissue grafting. (1-3 teeth may be treated. In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment). Root coverage is not desired at the time of grafting. Females of childbearing potential must have a documented negative urine pregnancy test. Subjects must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form. Subjects must be able and willing to follow study procedures and instructions. Exclusion Criteria: Subject with class III recession in the presence of a shallow vestibule or class IV recession. Subject with vestibule depth of less than 7mm from base of recession. Subject with any systemic conditions that could compromise wound healing and preclude periodontal surgery (i.e., diabetes mellitus, cancer, human immunodeficiency virus (HIV), bone metabolic diseases). Subject who is currently receiving or has received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery. Subject with the presence of acute infectious lesions in the areas intended for surgery. Subject who has used any tobacco product within 3 months. Subject who is taking intramuscular or intravenous bisphosphonates. Subject with only molar teeth suitable for soft tissue grafting. Subject with teeth that have Miller Grade 2 or higher mobility. Subject with known hypersensitivity to bovine collagen and/or iodine (shellfish allergy). Subject who has received an investigational drug or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental). Subject who was previously treated with Gintuit, Dermagraft or any other skin graft at the target site(s) or immediately adjacent teeth. Subject, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael McGuire, DDS

Organizational Affiliation

Perio Health Professionals, PLLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nevins Perio, LLC

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Michigan Center for Oral Health Research

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

Perio Health Professionals, PLLC

City

Houston

State/Province

Texas

ZIP/Postal Code

77063

Country

United States

Facility Name

University of Texas Health Science Center - San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229-3900

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21513473

Citation

McGuire MK, Scheyer ET, Nevins ML, Neiva R, Cochran DL, Mellonig JT, Giannobile WV, Bates D. Living cellular construct for increasing the width of keratinized gingiva: results from a randomized, within-patient, controlled trial. J Periodontol. 2011 Oct;82(10):1414-23. doi: 10.1902/jop.2011.100671. Epub 2011 Mar 29.

Results Reference

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Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration

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