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

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