NCT03093207

Omega-3 Fatty Acids Plus Low-dose Aspirin Daily Supplementation in Surgical Therapy to Treat Aggressive Periodontitis

Completed Phase 2, PHASE3 Results posted Last updated 17 November 2020

What this trial tests

Phase 2, PHASE3 trial testing Open flap debridement in Residual Disease in 34 participants. Completed in 29 June 2020.

Timeline

15 May 2017

Primary endpoint
1 October 2018

29 June 2020

Quick facts

Lead sponsor	Universidade Estadual Paulista Júlio de Mesquita Filho
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	34
Start date	15 May 2017
Primary completion	1 October 2018
Estimated completion	29 June 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Open flap debridement — full drug profile →
• Placebo
• Omega-3 polyunsaturated fatty acids — full drug profile →
• Aspirin — full drug profile →

Conditions studied

• Residual Disease — all drugs for Residual Disease →
• Aggressive Periodontitis — all drugs for Aggressive Periodontitis →

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho — full company profile →

Who can join

Adults 18 to 35, any sex, with Residual Disease or Aggressive Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Attachment Level at Baseline, 3 Months and 6 Months Primary · Baseline, 3 and 6 months

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.

Baseline

Group	Value	95% CI
Test Group	5.5	± 0.25
Control Group	5.29	± 0.16

3 months

Group	Value	95% CI
Test Group	4.64	± 0.29
Control Group	4.73	± 0.28

6 months

Group	Value	95% CI
Test Group	4.64	± 0.22
Control Group	4.97	± 0.25

Probing Depth at Baseline, 3 Months and 6 Months Secondary · Baseline, 3 and 6 months

Evaluate the difference between baseline and 6 months PB measures. PB: distance from the bottom of sulcus/pocket to gingival margin.

Baseline

Group	Value	95% CI
Test Group	5.17	± 0.2
Control Group	5.14	± 0.14

3 months

Group	Value	95% CI
Test Group	4.08	± 0.21
Control Group	3.76	± 0.2

6 months

Group	Value	95% CI
Test Group	4	± 0.15
Control Group	3.94	± 0.2

Percentage of Sites With Bleeding on Probe at Baseline, 3 Months and 6 Months Secondary · Baseline, 3 and 6 months

Evaluate the difference between baseline and 6 months BoP measures. BoP: bleeding that is induced by gentle probing of the sulcus/pocket.

Baseline

Group	Value	95% CI
Test Group	100
Control Group	100

3 months

Group	Value	95% CI
Test Group	76.47
Control Group	100

6 months

Group	Value	95% CI
Test Group	64.7
Control Group	64.7

Adverse events — posted to ClinicalTrials.gov

Time frame: During the 6 months post-treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Group

Serious: 0/17 (0%)

Deaths: 0/17

Test Group

Serious: 0/17 (0%)

Deaths: 0/17

Serious adverse events (2 terms)

Reaction	System	Control Group	Test Group
Stomachache	Gastrointestinal disorders	—	—
Internal bleeding	Gastrointestinal disorders	—	—

Most-reported serious reactions: Stomachache, Internal bleeding.

Data from ClinicalTrials.gov NCT03093207 adverse events section.

Sponsor's own description

The aim of this randomized controlled clinical trial of superiority will be to evaluate the effect of 3 g of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily supplementation over a period of 180 days as adjunct to surgical therapy of residual pockets from patients with generalized aggressive periodontitis. Probing depth, clinical attachment level, gingival index and concentration of microorganisms and cytokines at baseline, 3, and 6 months after the procedure will be evaluated.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.