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

NCT00587834 | Completed Phase 3 Results

• 1 other identifier: 06-PER-002-CTX
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (6)

• Color Same as Adjacent Tissues After 6 Months (Superiority)

  6 months

• Texture Same as Adjacent Tissues After 6 Months (Superiority)

  6 months

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

  6 months

• Patient Preference After 6 Months/Early Termination (Superiority)

  6 months

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

  6 months

Study Arms (2)

1

EXPERIMENTAL

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

Device: Gintuit

2

ACTIVE COMPARATOR

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

Other: Autologous palatal tissue

Interventions

Gintuit DEVICE

Application of Gintuit at Day 0 to the gingival bed

1

Autologous palatal tissue OTHER

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

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organogenesis: lead

Study Sites (4)

Nevins Perio, LLC

Boston, Massachusetts, 02114, United States

Location

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

Perio Health Professionals, PLLC

Houston, Texas, 77063, United States

Location

University of Texas Health Science Center - San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Related Publications (1)

• 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.

  PMID: 21513473 RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Limitations and Caveats

Secondary outcome measures were tested with a closed testing strategy; therefore pain was not tested (no p-value) because previous endpoint (site sensitivity) failed.

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Organogenesis Inc.

clinical@organo.com

781-575-0775

Study Officials

• Michael McGuire, DDS

  Perio Health Professionals, PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 8, 2012
• Results First Posted: November 8, 2012

Record last verified: 2012-10

Locations

US (4)