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A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva

Primary Purpose

Gingival Recession

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gintuit

autologous Free Gingival Graft (FGG)

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 18 years of age or older at the time of enrollment, and not older than seventy years.
Subject has at least two non-adjacent teeth with an insufficient zone of attached gingiva which requires soft tissue grafting. The two selected teeth must be located in contralateral quadrants. (In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but both teeth will get the same treatment).
Root coverage is not desired or indicated at the time of grafting.
Females of childbearing potential must have a documented negative urine or serum 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:

Teeth that have an insufficient zone of attached gingiva that would be best treated using soft tissue grafts, which would attempt to cover the denuded root surface.
Subjects with any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) which could compromise wound healing and preclude periodontal surgery.
Subjects who are currently receiving or have received within one week prior to study entry, systemic corticosteroids (including inhaled), immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
Subjects with the presence of acute infectious lesions in the areas intended for surgery.
Subjects who smoke.
Teeth requiring treatment are molars.
Teeth with axial mobility.
Known hypersensitivity to bovine collagen.
Subjects enrolled in medical, dental, or any investigational device study for any disease within the past four weeks.
Subjects who have received an investigational drug or biological treatment within the three months prior to study enrollment (medical or dental).
Subjects previously treated with Gintuit, Dermagraft or any other skin graft at the target site(s).
Subjects 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

PerioHealth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Split-mouth design: Treatment

Split-mouth design: Control

Arm Description

Outcomes

Primary Outcome Measures

Amount of attached gingiva

Change in the amount of attached gingiva

Secondary Outcome Measures

Inflammation

Change from baseline in inflammation score

Color of grafted tissue

Color match of the grafted tissue to the adjacent tissue

Texture of grafted tissue

Texture match of the grafted tissue to the adjacent tissue

Oral muscle pull

Resistance to oral muscle pull

Probing depth

Change in probing depth from baseline

Clinical attachment level (ie, distance from the cemento-enamel junction (CEJ; or another definite chosen landmark) to the base of the sulcus or periodontal pocket)

Change in clinical attachment level (mm) from baseline

Overall Subject Preference

VAS scale subject assessment of each treated site with anchors of "disappointed" and "fully satisfied".

Recession depth

Change in recession depth

Keratinized tissue

Width of keratinized tissue

Full Information

NCT ID

NCT01547962

First Posted

February 28, 2012

Last Updated

April 6, 2012

Sponsor

Organogenesis

1. Study Identification

Unique Protocol Identification Number

NCT01547962

Brief Title

A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva

Official Title

A Pilot Clinical Trial to Assess the Safety and Efficacy of Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) in Establishing a Functional Zone of Attached Gingiva

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

May 2006 (Actual)

Study Completion Date

May 2006 (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 the safety and efficacy of Gintuit compared to a free autogenous graft using donor tissue harvested from the subject's palate in the treatment of subjects who have an insufficient zone of attached gingiva associated with at least two non adjacent teeth. The trial is designed to demonstrate non-inferiority between treatment and control in the change in amount of attached gingiva over the 6 month observation period. Gintuit will be placed as a graft in one of the deficient zones, and a free autogenous graft will be placed in the other. The grafts will be evaluated clinically to determine the change in the amount of attached gingiva and on at least three subjects, a small biopsy will be taken to allow histologic evaluation and comparison of both grafts.

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

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Split-mouth design: Treatment

Arm Type

Experimental

Arm Title

Split-mouth design: Control

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Gintuit

Intervention Description

Gintuit is prepared in a "S" fold and trimmed to fit the prepared wound bed, with a standardized width of 5 mm and sutured in place with a 5/0 gut suture.

Intervention Type

Other

Intervention Name(s)

autologous Free Gingival Graft (FGG)

Intervention Description

Autologous FGG harvested from the subject's palate, the width of the FGG will be 5 mm and sutured in place with a 5/0 gut suture.

Primary Outcome Measure Information:

Title

Amount of attached gingiva

Description

Change in the amount of attached gingiva

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Inflammation

Description

Change from baseline in inflammation score

Time Frame

week 1, week 4, month 3 and month 6

Title

Color of grafted tissue

Description

Color match of the grafted tissue to the adjacent tissue

Time Frame

4 weeks, 3 months, 6 months

Title

Texture of grafted tissue

Description

Texture match of the grafted tissue to the adjacent tissue

Time Frame

4 weeks, 3 months, 6 months

Title

Oral muscle pull

Description

Resistance to oral muscle pull

Time Frame

6 months

Title

Probing depth

Description

Change in probing depth from baseline

Time Frame

6 months

Title

Clinical attachment level (ie, distance from the cemento-enamel junction (CEJ; or another definite chosen landmark) to the base of the sulcus or periodontal pocket)

Description

Change in clinical attachment level (mm) from baseline

Time Frame

6 months

Title

Overall Subject Preference

Description

VAS scale subject assessment of each treated site with anchors of "disappointed" and "fully satisfied".

Time Frame

6 months

Title

Recession depth

Description

Change in recession depth

Time Frame

3 months, 6 months

Title

Keratinized tissue

Description

Width of keratinized tissue

Time Frame

3 months, 6 months

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 18 years of age or older at the time of enrollment, and not older than seventy years. Subject has at least two non-adjacent teeth with an insufficient zone of attached gingiva which requires soft tissue grafting. The two selected teeth must be located in contralateral quadrants. (In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but both teeth will get the same treatment). Root coverage is not desired or indicated at the time of grafting. Females of childbearing potential must have a documented negative urine or serum 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: Teeth that have an insufficient zone of attached gingiva that would be best treated using soft tissue grafts, which would attempt to cover the denuded root surface. Subjects with any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) which could compromise wound healing and preclude periodontal surgery. Subjects who are currently receiving or have received within one week prior to study entry, systemic corticosteroids (including inhaled), immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery. Subjects with the presence of acute infectious lesions in the areas intended for surgery. Subjects who smoke. Teeth requiring treatment are molars. Teeth with axial mobility. Known hypersensitivity to bovine collagen. Subjects enrolled in medical, dental, or any investigational device study for any disease within the past four weeks. Subjects who have received an investigational drug or biological treatment within the three months prior to study enrollment (medical or dental). Subjects previously treated with Gintuit, Dermagraft or any other skin graft at the target site(s). Subjects 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.

Facility Information:

Facility Name

PerioHealth

City

Houston

State/Province

Texas

ZIP/Postal Code

77063

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18834238

Citation

McGuire MK, Scheyer ET, Nunn ME, Lavin PT. A pilot study to evaluate a tissue-engineered bilayered cell therapy as an alternative to tissue from the palate. J Periodontol. 2008 Oct;79(10):1847-56. doi: 10.1902/jop.2008.080017.

Results Reference

result

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A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva

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