Trial Outcomes & Findings for Short-term Effect of 2% Atorvastatin Dentifrice in Periodontal Status. (NCT NCT01929135)
NCT ID: NCT01929135
Last Updated: 2014-07-28
Results Overview
PISA will be computed through an Excel spreadsheet, using data of clinical attachment level, gingival recession and bleeding on probing. Change in PISA: baseline measure minus 1 month later measure.
COMPLETED
PHASE2
38 participants
baseline and 1 month later of intervention
2014-07-28
Participant Flow
The investigation was conducted at the Department of Periodontology of Universidad de Los Andes. Patients were enrolled in the study between June 2013 and August 2013, derived from the Health Care Center, Universidad de los Andes (San Bernardo, Santiago, Chile).
Participant milestones
| Measure |
Atorvastatin Group
A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days..
|
Placebo Group
A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Atorvastatin Group
A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days..
|
Placebo Group
A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Short-term Effect of 2% Atorvastatin Dentifrice in Periodontal Status.
Baseline characteristics by cohort
| Measure |
Atorvastatin Group
n=18 Participants
A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days.
|
Placebo Group
n=18 Participants
A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.39 years
STANDARD_DEVIATION 9.07 • n=93 Participants
|
45.72 years
STANDARD_DEVIATION 9.08 • n=4 Participants
|
45.56 years
STANDARD_DEVIATION 8.95 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Diabetic
diabetic patients
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Diabetic
non-diabetic patients
|
15 participants
n=93 Participants
|
17 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
Smokers
smokers patients
|
5 participants
n=93 Participants
|
11 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Smokers
non-smokers patients
|
13 participants
n=93 Participants
|
7 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
Probing depth
|
3.74 millimeters
STANDARD_DEVIATION 0.87 • n=93 Participants
|
2.80 millimeters
STANDARD_DEVIATION 0.86 • n=4 Participants
|
3.27 millimeters
STANDARD_DEVIATION 0.98 • n=27 Participants
|
|
Clinical attachment level
|
3.73 millimeters
STANDARD_DEVIATION 1.52 • n=93 Participants
|
2.52 millimeters
STANDARD_DEVIATION 0.90 • n=4 Participants
|
3.12 millimeters
STANDARD_DEVIATION 1.38 • n=27 Participants
|
|
Bleeding on probing
|
77.86 Percentage of probed sites with BOP
STANDARD_DEVIATION 18.12 • n=93 Participants
|
53.47 Percentage of probed sites with BOP
STANDARD_DEVIATION 17.77 • n=4 Participants
|
65.67 Percentage of probed sites with BOP
STANDARD_DEVIATION 21.59 • n=27 Participants
|
|
Recession
|
0.01 millimeters
STANDARD_DEVIATION 1.14 • n=93 Participants
|
0.28 millimeters
STANDARD_DEVIATION 0.94 • n=4 Participants
|
0.14 millimeters
STANDARD_DEVIATION 1.04 • n=27 Participants
|
|
Oral hygienic index
|
7.32 percent of surface without plaque
STANDARD_DEVIATION 16.85 • n=93 Participants
|
12.88 percent of surface without plaque
STANDARD_DEVIATION 18.01 • n=4 Participants
|
10.10 percent of surface without plaque
STANDARD_DEVIATION 17.42 • n=27 Participants
|
|
Gingival index
|
1.95 score on a scale
STANDARD_DEVIATION 0.31 • n=93 Participants
|
1.54 score on a scale
STANDARD_DEVIATION 0.21 • n=4 Participants
|
1.74 score on a scale
STANDARD_DEVIATION 0.33 • n=27 Participants
|
|
Periodontal inflamed surface area (PISA)
|
1093.18 square millimeters
STANDARD_DEVIATION 435.96 • n=93 Participants
|
814.82 square millimeters
STANDARD_DEVIATION 488.54 • n=4 Participants
|
954 square millimeters
STANDARD_DEVIATION 477.67 • n=27 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 month later of interventionPISA will be computed through an Excel spreadsheet, using data of clinical attachment level, gingival recession and bleeding on probing. Change in PISA: baseline measure minus 1 month later measure.
Outcome measures
| Measure |
Atorvastatin Toothpaste
n=18 Participants
A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.
Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days.
|
Non Medicated Gel Toothpaste
n=18 Participants
A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.
Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days.
|
|---|---|---|
|
Change in Periodontal Inflammation Surface Area (PISA)
|
638.16 square millimeters
Standard Deviation 398.74
|
288.72 square millimeters
Standard Deviation 168.20
|
SECONDARY outcome
Timeframe: baseline and 1 month laterThe PD will be defined as the distance from the free gingival margin to the bottom of the pocket. For each tooth will be conducted periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal, mesiolingual / palatal, mediolingual / palatal, distolingual/ palatal). Change in mean PD: baseline measure minus 1 month later measure.
Outcome measures
| Measure |
Atorvastatin Toothpaste
n=18 Participants
A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.
Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days.
|
Non Medicated Gel Toothpaste
n=18 Participants
A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.
Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days.
|
|---|---|---|
|
Change in Mean Pocket Depth (PD)
|
1.29 millimeters
Standard Deviation 0.45
|
0.70 millimeters
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: baseline and 1 month after interventionThe Clinical Attachment Level (CAL) is defined as the distance from the cement-enamel junction to the fornix of the pocket. For each tooth will be performed periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal mesiolingual / palatal mediolingual / distolingual palatal / lingual). Change in CAL: baseline measure minus 1 month later measure.
Outcome measures
| Measure |
Atorvastatin Toothpaste
n=18 Participants
A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.
Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days.
|
Non Medicated Gel Toothpaste
n=18 Participants
A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.
Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days.
|
|---|---|---|
|
Change in Clinical Attachment Level (CAL)
|
0.89 millimeters
Standard Deviation 0.33
|
0.49 millimeters
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: baseline and 1 month after interventionThe bleeding on probing index (BOP) will be determined by assigning + to the presence of bleeding on vestibular / palatine probing of the tooth examined and with a sign - the abscence. Later the + signs will be summed and divided by the number of sites examined. Change in BOP: baseline measure minus 1 month later measure.
Outcome measures
| Measure |
Atorvastatin Toothpaste
n=18 Participants
A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.
Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days.
|
Non Medicated Gel Toothpaste
n=18 Participants
A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.
Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days.
|
|---|---|---|
|
Change in Bleeding on Probing Index (BOP)
|
64.42 percentage of BOP
Standard Deviation 18.08
|
28.56 percentage of BOP
Standard Deviation 15.56
|
SECONDARY outcome
Timeframe: baseline and 1 month after interventionDetermined as score assigned to each site evaluated respect to clinical criteria as followed: Score Criteria: 0\. No inflammation 1. Mild inflammation, slight change in color, slight edema, no bleeding on probing. 2. Moderate inflammation, moderate glazing, redness, bleeding on probing. 3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding. Then was calculated a score for each sextant summed the score and divided by the number of examined sites. Later was summed each sextant score and divided by sextant evaluated. The change was calculated as baseline measure minus 1 month later measure.
Outcome measures
| Measure |
Atorvastatin Toothpaste
n=18 Participants
A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.
Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days.
|
Non Medicated Gel Toothpaste
n=18 Participants
A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.
Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days.
|
|---|---|---|
|
Change in Gingival Index
|
1.04 score on a scale
Standard Deviation 0.54
|
0.54 score on a scale
Standard Deviation 0.42
|
Adverse Events
Atorvastatin Group
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place