Trial Outcomes & Findings for Omega-3 Plus Low-dose Aspirin Daily Supplementation in Non-surgical Therapy to Treat Aggressive Periodontitis (NCT NCT03093246)
NCT ID: NCT03093246
Last Updated: 2021-12-28
Results Overview
Evaluate the difference between baseline and 6 months PD measures.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
38 participants
Primary outcome timeframe
Baseline, 3 and 6 months
Results posted on
2021-12-28
Participant Flow
Participant milestones
| Measure |
Control Group
In this group (n = 19), patients took placebo pills and full-mouth ultrasonic debridement was performed to treat diseased sites.
Placebo: Placebo pills over a period of 180 days
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
|
Test Group
In this group (n = 19), patients took 900 mg of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement was performed to treat diseased sites.
Omega-3 polyunsaturated fatty acids: 900 mg of omega-3 polyunsaturated fatty acids daily supplementation over a period of 180 days
Aspirin: 100 mg of aspirin daily supplementation over a period of 180 days
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=19 Participants
In this group (n = 19), patients received placebo pills over a period of 180 days and full-mouth ultrasonic debridement was performed to treat diseased sites.
|
Test Group
n=19 Participants
In this group (n = 19), patients received 900 mg of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement was performed to treat diseased sites.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.42 years
STANDARD_DEVIATION 5.79 • n=19 Participants
|
32.84 years
STANDARD_DEVIATION 5.47 • n=19 Participants
|
31.63 years
STANDARD_DEVIATION 5.6 • n=38 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=19 Participants
|
12 Participants
n=19 Participants
|
26 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=19 Participants
|
7 Participants
n=19 Participants
|
12 Participants
n=38 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
19 Participants
n=19 Participants
|
19 Participants
n=19 Participants
|
38 Participants
n=38 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 and 6 monthsEvaluate the difference between baseline and 6 months PD measures.
Outcome measures
| Measure |
Control Group
n=19 Participants
In this group (n = 19), patients took placebo pills over a period of 180 days and received full-mouth ultrasonic debridement to treat diseased sites.
|
Test Group
n=19 Participants
In this group (n = 19), patients will take 900 mg of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement was performed to treat diseased sites.
|
|---|---|---|
|
Change in Probing Depth
3 months
|
3.38 milimeters
Standard Deviation 0.14
|
3.26 milimeters
Standard Deviation 0.13
|
|
Change in Probing Depth
6 months
|
3.37 milimeters
Standard Deviation 0.14
|
3.25 milimeters
Standard Deviation 0.13
|
|
Change in Probing Depth
Baseline
|
3.88 milimeters
Standard Deviation 0.15
|
3.74 milimeters
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 monthsEvaluate the difference between baseline and 6 months CAL measures.
Outcome measures
| Measure |
Control Group
n=19 Participants
In this group (n = 19), patients took placebo pills over a period of 180 days and received full-mouth ultrasonic debridement to treat diseased sites.
|
Test Group
n=19 Participants
In this group (n = 19), patients will take 900 mg of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement was performed to treat diseased sites.
|
|---|---|---|
|
Change in Clinical Attachment Level
Baseline
|
3.94 milimeters
Standard Deviation 0.17
|
4.01 milimeters
Standard Deviation 0.21
|
|
Change in Clinical Attachment Level
3 months
|
3.58 milimeters
Standard Deviation 0.17
|
3.65 milimeters
Standard Deviation 0.21
|
|
Change in Clinical Attachment Level
6 months
|
3.59 milimeters
Standard Deviation 0.17
|
3.64 milimeters
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 monthsEvaluate the difference between baseline and 6 months BoP measures
Outcome measures
| Measure |
Control Group
n=19 Participants
In this group (n = 19), patients took placebo pills over a period of 180 days and received full-mouth ultrasonic debridement to treat diseased sites.
|
Test Group
n=19 Participants
In this group (n = 19), patients will take 900 mg of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement was performed to treat diseased sites.
|
|---|---|---|
|
Change in Bleeding on Probe
Baseline
|
54.11 percentage of sites with BoP
Standard Deviation 4.97
|
44.58 percentage of sites with BoP
Standard Deviation 3.72
|
|
Change in Bleeding on Probe
3 months
|
33.27 percentage of sites with BoP
Standard Deviation 3.72
|
27.41 percentage of sites with BoP
Standard Deviation 2.35
|
|
Change in Bleeding on Probe
6 months
|
31.77 percentage of sites with BoP
Standard Deviation 3.58
|
26.17 percentage of sites with BoP
Standard Deviation 2.18
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Mauro Pedrine Santamaria
São Paulo State University - Unesp
Phone: +5516981937777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place