Phase 2
Completed N=13
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency
Interdental Papillary Insufficiency
Source: ClinicalTrials.gov NCT00655889 ↗
Enrolled (actual)
13
Serious AEs
7.7%
Results posted
Aug 2013
Primary outcomePrimary: Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) — 10 participants
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 identification number)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) |
10 | — |
| PRIMARY Number of Responders Based on the Average Patient Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) |
9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00655889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.