Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency

Castle Creek Biosciences

Status and phase: Completed; Phase 2

Conditions: Interdental Papillary Insufficiency

Treatments: Biological: Autologous Human Fibroblasts (azficel-T)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00655889

IT-G-003

Details and patient eligibility

About

The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM in subjects with maxillary lesions who were treated in a previous study (IT-G-002, no NCT identification number)

Enrollment: 13 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must be 18-70 years of age
• Subject was treated in IT-G-002 (no NCT identification number)
• Subject has maxillary interproximal recession defects
• Natural teeth must be present on both sides of each area to be treated
• Negative pregnancy test and use of acceptable birth control (females of childbearing age)

Exclusion criteria

• Subjects who participated in other clinical trials within 30 days prior to enrollment
• Interproximal spaces including root grooves or furcations must not be involved
• Subjects with poor oral hygiene
• Subjects with a systemic condition, which would preclude periodontal treatment
• Subjects with acute infectious lesions in the treatment areas
• Subjects with open interproximal contact at study sites
• Subjects who must receive prophylactic antibiotics before dental procedures
• Subjects on chronic antibiotic or steroidal therapy
• Subjects with interproximal probing depths > 3 mm around study lesions
• Subjects who smoke
• Subjects taking medications associated with the development of drug induced gingival hyperplasia
• Subjects with radiographic evidence of pathology
• Subjects with tooth mobility exceeding a score of 1
• Subjects with parafunctional habits and not wearing bite guard
• Subjects with interproximal spaces associated with teeth without an adequate zone of keratinized tissue
• Subjects where the etiology of the interproximal papillary recession has not been controlled
• Subjects who have received a crown or pontic on one or both teeth involved in the interproximal space to be treated

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Active

Experimental group

Treatment:

Biological: Autologous Human Fibroblasts (azficel-T)