A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage

Phase 1

Terminated

• Conditions: Gingival Recession
• Interventions: Device: CelTx; Other: Autologous sub-epithelial connective tissue graft

• Registration Number: NCT00679081
• Lead Sponsor: Organogenesis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-16
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2011-10-10
• Results First Submitted QC: 2011-10-10
• Results First Posted: 2011-11-21
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CelTx	CelTx	CelTx
Autologous CTG	Autologous sub-epithelial connective tissue graft	Autologous sub-epithelial connective tissue graft

Primary Outcome Measures

Name	Time	Method
Overall Rate of Adverse Events (AEs)	6-month	Adverse events were collected at every visit throughout the 6 month duration.; An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition.

Secondary Outcome Measures

Name	Time	Method
Periodontal Health Measures	6-months
Aesthetic Measures	6-months
Post-Surgical Subject Comfort Measures	4-weeks
Subject Preference Measures	6-months

Trial Locations

Locations (1)

Perio Health Professionals, PLLC; 🇺🇸 Houston, Texas, United States