Interdental Papillary Insufficiency
Conditions
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 identification number)
Interventions
BIOLOGICALAutologous Human Fibroblasts (azficel-T)
1. Collection of biopsy from palate 2. Papillary priming procedure 3. Seven injection treatments to target sites 4. Performance of study assessments (investigator and subject)
Sponsors
Castle Creek Biosciences, LLC.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) | Baseline (prior to first study treatment) compared to six months after first treatment | A patient was considered a responder in this outcome measure if the average Investigator's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best. |
| Number of Responders Based on the Average Patient Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) | Baseline (prior to first study treatment) compared to six months after first treatment | A patient was considered a responder in this outcome measure if the average patient's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited between July 17, 2006 to September 11, 2006.
Participants by arm
| Arm | Count |
|---|---|
| Autologous Fibroblasts Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inadequate cell growth | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Autologous Fibroblasts |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 13 |
| serious Total, serious adverse events | 1 / 13 |
Outcome results
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)
A patient was considered a responder in this outcome measure if the average Investigator's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.
Time frame: Baseline (prior to first study treatment) compared to six months after first treatment
Population: Subjects who received at least one treatment during the study were included in the Intent to Treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autologous Fibroblasts | 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 |
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)
A patient was considered a responder in this outcome measure if the average patient's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.
Time frame: Baseline (prior to first study treatment) compared to six months after first treatment
Population: Subjects who received at least one treatment during the study were included in the Intent to Treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autologous Fibroblasts | 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 participants |