Effect of Omega 3 on Periodontitis in Postmenopausal Women

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Dietary Supplement: Omega 3 fatty acids; Procedure: scaling and root planing; Other: placebo soft gelatin capsules

• Registration Number: NCT02764879
• Lead Sponsor: October 6 University

Brief Summary

The study was aimed to investigating changes in periodontal parameters and superoxide dismutase activity after root surface debridement with and without Omega 3 fatty acids (ω-3 FAs) supplementation in postmenopausal women. Adjunctive Omega 3 fatty acids supplements reduce periodontal inflammation and improve the status of systemic enzymatic antioxidants in postmenopausal women.

Detailed Description

Fifty postmenopausal women with chronic periodontitis were divided randomly into two groups: Group 1 (n=25) were provided periodontal treatment in the form of scaling and root planing (SRP) plus placebo soft gelatin capsules while group 2 (n=25): patients were received SRP along with systemic administration of Omega 3 fatty acids. Clinical parameters and superoxide dismutase (SOD) activity in the gingival crevicular fluid were recorded at baseline, 3 and 6 months after therapy. The research has been conducted between July 2014 and June 2015. By the end of the study period, the Omega 3 treated group was able to achieve a greater mean probing pocket depth reduction, mean gain in clinical attachment level, as well as greater increase in SOD activity (P\<0.01) compared to SRP alone.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-01
• Study Completion: 2015-06
• Status Verified: 2016-05
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-05
• Last Update Submitted: 2016-05-05
• Study First Posted: 2016-05-06
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Postmenopausal women with generalized chronic periodontitis (clinical attachment loss more than 30% of the teeth)
• With probing pocket depth ≥ 5mm.
• The age ranged between 45 and 60 years (To avoid the wide variation between individual cases in order to make the sample more homogeneous. Furthermore elderly patients above 60 years are usually not willing to have periodontal treatment).
• Postmenopausal status for at least 1 year.
• Presence of at least six teeth in the mouth.

Exclusion Criteria

• Any systemic disease that affect the periodontium.
• Women who take anti-inflammatory drugs, antibiotics or vitamins within the previous 3 month.
• Women who use mouth washes regularly
• Smoking
• History of alcohol abuse
• Participation in other clinical trials.
• Obese women (Body mass index (BMI) ≥ 30).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
omega 3 group	scaling and root planing	scaling and root planing omega3 received 2 times daily-for 6 months
control group	scaling and root planing	scaling and root planing placebo soft gelatin capsules 2 times daily-for 6 months
control group	placebo soft gelatin capsules	scaling and root planing placebo soft gelatin capsules 2 times daily-for 6 months
omega 3 group	Omega 3 fatty acids	scaling and root planing omega3 received 2 times daily-for 6 months

Primary Outcome Measures

Name	Time	Method
superoxide dismutase (SOD) activity in the gingival crevicular fluid	up to 6 months	Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 3 and 6 months post treatment.

Secondary Outcome Measures

Name	Time	Method
Probing pocket depth	up to 6 months	Probing pocket depth in mm was recorded at baseline, 3, 6 months treatment
Gingival index	up to 6 months	Gingival index was recorded at baseline, 3, 6 months post treatment
Clinical attachment level	up to 6 months	Clinical attachment level was recorded at baseline, 3 and 6 months post treatment
Plaque Index	up to 6 months	plaque index was recorded at baseline and at 3 and 6 months post treatment.