Phase 3 N=96 Randomized Treatment

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

Gingival Recession

Bottom Line

View on ClinicalTrials.gov: NCT00587834 ↗

Enrolled (actual)

Serious AEs

0.6%

Results posted

Nov 2012

Primary outcome: Primary: Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site. — 95.3 percentage of participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Gintuit (Device); Autologous palatal tissue (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organogenesis
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.	95.3	<0.0001 sig
SECONDARY Color Same as Adjacent Tissues After 6 Months (Superiority)	23; 0; 56; 6	<0.0001 sig
SECONDARY Texture Same as Adjacent Tissues After 6 Months (Superiority)	46; 0; 35; 4	<0.0001 sig
SECONDARY Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.	100	<0.0001 sig
SECONDARY Patient Preference After 6 Months/Early Termination (Superiority)	61	<0.0001 sig
SECONDARY Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)	67; 3; 1; 0	0.3173
SECONDARY Pain Absent After 3 Days (Superiority)	—	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00587834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.