Trial Outcomes & Findings for Omega-3 Fatty Acids Plus Low-dose Aspirin Daily Supplementation in Surgical Therapy to Treat Aggressive Periodontitis (NCT NCT03093207)
NCT ID: NCT03093207
Last Updated: 2020-11-17
Results Overview
Evaluate the difference between baseline and 6 months CAL measures. CAL: distance from bottom of sulcus/pocket to the cement-enamel junction (CEJ). The CEJ will be identified by careful probe on cervical area.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
34 participants
Primary outcome timeframe
Baseline, 3 and 6 months
Results posted on
2020-11-17
Participant Flow
Participant milestones
| Measure |
Control Group
In this group (n = 17), patients received placebo pills and open flap debridement to treat residual pockets.
Open flap debridement: Open flap debridement was performed to decontaminate root surface
Placebo: Placebo pills over a period of 180 days
|
Test Group
In this group (n = 17), patients received 3 g of omega-3 polyunsaturated fatty acids plus 100 mg of aspirin daily supplementation over a period of 180 days and open flap debridement was performed to treat residual pockets.
Open flap debridement: Open flap debridement was performed to decontaminate root surface
Omega-3 polyunsaturated fatty acids: 3 g 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
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
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=17 Participants
In this group (n = 17), patients will take placebo pills and open flap debridement will be performed to treat residual pockets.
Open flap debridement: Open flap debridement will be performed to decontaminate root surface
Placebo: Placebo pills over a period of 180 days
|
Test Group
n=17 Participants
In this group (n = 17), patients will take 3 g of omega-3 polyunsaturated fatty acids plus 100 mg of aspirin daily supplementation over a period of 180 days and open flap debridement will be performed to treat residual pockets.
Open flap debridement: Open flap debridement will be performed to decontaminate root surface
Omega-3 polyunsaturated fatty acids: 3 g 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
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=34 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=17 Participants
|
17 Participants
n=17 Participants
|
34 Participants
n=34 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=34 Participants
|
|
Age, Continuous
|
33.06 years
STANDARD_DEVIATION 5.13 • n=17 Participants
|
34.17 years
STANDARD_DEVIATION 4.9 • n=17 Participants
|
33.61 years
STANDARD_DEVIATION 5.01 • n=34 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=17 Participants
|
13 Participants
n=17 Participants
|
26 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=17 Participants
|
4 Participants
n=17 Participants
|
8 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
17 participants
n=17 Participants
|
17 participants
n=17 Participants
|
34 participants
n=34 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 and 6 monthsEvaluate the difference between baseline and 6 months CAL measures. CAL: distance from bottom of sulcus/pocket to the cement-enamel junction (CEJ). The CEJ will be identified by careful probe on cervical area.
Outcome measures
| Measure |
Test Group
n=17 Pockets treated with surgery
In this group (n = 17), patients received 3 g of omega-3 polyunsaturated fatty acids plus 100 mg of aspirin daily supplementation over a period of 180 days and open flap debridement was performed to treat residual pockets.
Open flap debridement: Open flap debridement was performed to decontaminate root surface
Omega-3 polyunsaturated fatty acids: 3 g 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
|
Control Group
n=17 Pockets treated with surgery
In this group (n = 17), patients received placebo pills over a period of 180 days and open flap debridement was performed to treat residual pockets.
Open flap debridement: Open flap debridement was performed to decontaminate root surface
|
|---|---|---|
|
Clinical Attachment Level at Baseline, 3 Months and 6 Months
Baseline
|
5.5 mm
Standard Error 0.25
|
5.29 mm
Standard Error 0.16
|
|
Clinical Attachment Level at Baseline, 3 Months and 6 Months
3 months
|
4.64 mm
Standard Error 0.29
|
4.73 mm
Standard Error 0.28
|
|
Clinical Attachment Level at Baseline, 3 Months and 6 Months
6 months
|
4.64 mm
Standard Error 0.22
|
4.97 mm
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 monthsEvaluate the difference between baseline and 6 months PB measures. PB: distance from the bottom of sulcus/pocket to gingival margin.
Outcome measures
| Measure |
Test Group
n=17 Pockets treated with surgery
In this group (n = 17), patients received 3 g of omega-3 polyunsaturated fatty acids plus 100 mg of aspirin daily supplementation over a period of 180 days and open flap debridement was performed to treat residual pockets.
Open flap debridement: Open flap debridement was performed to decontaminate root surface
Omega-3 polyunsaturated fatty acids: 3 g 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
|
Control Group
n=17 Pockets treated with surgery
In this group (n = 17), patients received placebo pills over a period of 180 days and open flap debridement was performed to treat residual pockets.
Open flap debridement: Open flap debridement was performed to decontaminate root surface
|
|---|---|---|
|
Probing Depth at Baseline, 3 Months and 6 Months
Baseline
|
5.17 mm
Standard Deviation 0.2
|
5.14 mm
Standard Deviation 0.14
|
|
Probing Depth at Baseline, 3 Months and 6 Months
3 months
|
4.08 mm
Standard Deviation 0.21
|
3.76 mm
Standard Deviation 0.2
|
|
Probing Depth at Baseline, 3 Months and 6 Months
6 months
|
4 mm
Standard Deviation 0.15
|
3.94 mm
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 monthsEvaluate the difference between baseline and 6 months BoP measures. BoP: bleeding that is induced by gentle probing of the sulcus/pocket.
Outcome measures
| Measure |
Test Group
n=17 Pockets treated with surgery
In this group (n = 17), patients received 3 g of omega-3 polyunsaturated fatty acids plus 100 mg of aspirin daily supplementation over a period of 180 days and open flap debridement was performed to treat residual pockets.
Open flap debridement: Open flap debridement was performed to decontaminate root surface
Omega-3 polyunsaturated fatty acids: 3 g 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
|
Control Group
n=17 Pockets treated with surgery
In this group (n = 17), patients received placebo pills over a period of 180 days and open flap debridement was performed to treat residual pockets.
Open flap debridement: Open flap debridement was performed to decontaminate root surface
|
|---|---|---|
|
Percentage of Sites With Bleeding on Probe at Baseline, 3 Months and 6 Months
Baseline
|
100 percentage of sites with BoP
|
100 percentage of sites with BoP
|
|
Percentage of Sites With Bleeding on Probe at Baseline, 3 Months and 6 Months
3 months
|
76.47 percentage of sites with BoP
|
100 percentage of sites with BoP
|
|
Percentage of Sites With Bleeding on Probe at Baseline, 3 Months and 6 Months
6 months
|
64.7 percentage of sites with BoP
|
64.7 percentage of sites with BoP
|
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
| Measure |
Control Group
n=17 participants at risk
In this group (n = 17), patients received placebo pills and open flap debridement to treat residual pockets.
Open flap debridement: Open flap debridement was performed to decontaminate root surface
Placebo: Placebo pills over a period of 180 days
|
Test Group
n=17 participants at risk
In this group (n = 17), patients received 3 g of omega-3 polyunsaturated fatty acids plus 100 mg of aspirin daily supplementation over a period of 180 days and open flap debridement was performed to treat residual pockets.
Open flap debridement: Open flap debridement was performed to decontaminate root surface
Omega-3 polyunsaturated fatty acids: 3 g 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
|
|---|---|---|
|
Gastrointestinal disorders
Stomachache
|
0.00%
0/17 • During the 6 months post-treatment
|
0.00%
0/17 • During the 6 months post-treatment
|
|
Gastrointestinal disorders
Internal bleeding
|
0.00%
0/17 • During the 6 months post-treatment
|
0.00%
0/17 • During the 6 months post-treatment
|
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