Status:
COMPLETED
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency
Lead Sponsor:
Castle Creek Biosciences, LLC.
Conditions:
Interdental Papillary Insufficiency
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ide...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00655889
Start Date
January 1 2006
End Date
July 1 2008
Last Update
March 23 2021
Active Locations (1)
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1
Perio-Health Professionals, Inc.
Houston, Texas, United States, 77063