Clinical trial NCT00679081: A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage
Official title: A Prospective, Randomized, Controlled Pilot Study of CelTx(TM) (Apligraf®) as an Alternative to Tissue From the Palate in the Treatment of Gingival Recession Requiring Root Coverage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Gingival Recession
Lead sponsor: Organogenesis
Sponsor class: INDUSTRY
First posted: 2008-05-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate CelTx as an alternative to tissue from the palate in the treatment of subjects with Miller Class I or II recession defects who desire root coverage. It is anticipated that this study will demonstrate that CelTx is a safe alternative to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and wound healing.


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 Miller Class I or II buccal recession (≥ 3 mm) that requires soft tissue grafting. (Teeth may be treated with a maximum difference of 2 mm with respect to depth and width).
* Females of childbearing potential must have a documented negative urine pregnancy test and must agree to continue acceptable methods of contraception for 6 months post surgery.
* Subjects must have read, understood and signed an institutional review board (IRB)-approved Informed Consent Form (ICF).
* Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

* Subject has extremely prominent root surfaces (\> 1/2 the diameter of the root facial to cortical plate).
* Subject has interproximal attachment loss beyond the CEJ.
* Subject with teeth that have a Miller Grade 2 or higher mobility.
* Subjects with Class V restorations.
* Subjects with crowns on the teeth selected for treatment.
* Subjects who have had endodontic therapy in the last 6 months on the teeth selected for treatment.
* Subjects who have used any tobacco product within the past 3 months.
* Subjects with only molar teeth suitable for soft tissue grafting.
* Subject has probing pocket depth \>/= 4 mm at either surgical site.
* Female subjects who are pregnant or lactating.
* Subjects with any systemic conditions (i.e., uncontrolled diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and preclude periodontal surgery.
* Subjects who are currently receiving or have 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.
* Subjects with the presence of acute infectious lesions.
* Subjects taking intramuscular or intravenous bisphosphonates.
* Subjects with a known hypersensitivity to bovine collagen and/or iodine (shellfish allergy).
* Subjects who have received an investigational drug, device or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental).
* Subjects previously treated with Apligraf/CelTx, Dermagraft or any other cell-based product, including autologous tissue at the target site(s) or immediately adjacent teeth.
* 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

Primary outcomes:
measure: Overall Rate of Adverse Events (AEs)
timeFrame: 6-month
Secondary outcomes:
measure: Periodontal Health Measures
timeFrame: 6-months
measure: Aesthetic Measures
timeFrame: 6-months
measure: Post-Surgical Subject Comfort Measures
timeFrame: 4-weeks
measure: Subject Preference Measures
timeFrame: 6-months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Perio Health Professionals, PLLC
state: Texas
Study officials:
affiliation: Perio Health Professionals, PLLC
name: Michael McGuire, DDS
role: PRINCIPAL_INVESTIGATOR
References: