Trial Outcomes & Findings for A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage (NCT NCT00679081)
NCT ID: NCT00679081
Last Updated: 2012-01-11
Results Overview
Adverse events were collected at every visit throughout the 6 month duration. An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
6-month
Results posted on
2012-01-11
Participant Flow
Participant milestones
| Measure |
CelTx and Autologous CTG; Split-mouth Design
Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
CelTx and Autologous CTG; Split-mouth Design
Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage
Baseline characteristics by cohort
| Measure |
CelTx and Autologous CTG; Split-mouth Design
n=15 Participants
Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
42.5 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-monthAdverse events were collected at every visit throughout the 6 month duration. An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition.
Outcome measures
| Measure |
CelTx Site
n=15 Participants
Adverse events occurring at the CelTx site
|
Graft Site
n=15 Participants
Adverse events occurring at the autologous sub-epithelial connective tissue graft site
|
Other Location
n=15 Participants
Adverse events occurring at a site other than the CelTx or Autologous graft sites
|
|---|---|---|---|
|
Overall Rate of Adverse Events (AEs)
|
2 participants
|
2 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 6-monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6-monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4-weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6-monthsOutcome measures
Outcome data not reported
Adverse Events
CelTx Site
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Graft Site
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Other Location
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CelTx Site
n=15 participants at risk
Adverse events occurring at the CelTx site
|
Graft Site
n=15 participants at risk
Adverse events occurring at the autologous sub-epithelial connective tissue graft site
|
Other Location
n=15 participants at risk
Adverse events occurring at a site other than the CelTx or Autologous graft sites
|
|---|---|---|---|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
13.3%
2/15 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Oral Mucosa Erosion
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
General disorders
Impaired Healing
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
|
Infections and infestations
Conjunctivitis Infective
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 2 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
13.3%
2/15 • Number of events 3 • 6 months
|
|
Injury, poisoning and procedural complications
Gingival Injury
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Injury, poisoning and procedural complications
Suture Related Complication
|
6.7%
1/15 • Number of events 1 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic Granuloma
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for at least 30 days in advance of public release. The sponsor can request removal of any confidential or proprietary information provided by sponsor and extend such review period for another 90 days to file patent applications or take other steps to protect the sponsor's intellectual property interests.
- Publication restrictions are in place
Restriction type: OTHER