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Houston, Texas 77063


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)


Inclusion Criteria: - Subject must be 18-70 years of age - Subject was treated in IT-G-002 - 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



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Location Contact:

Houston, Texas 77063
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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