Effect of Omega 3 on Periodontitis in Postmenopausal Women

NCT ID: NCT02764879

Last Updated: 2016-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-06-30

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.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

omega 3 group

scaling and root planing omega3 received 2 times daily-for 6 months

Group Type: EXPERIMENTAL

Omega 3 fatty acids

Intervention Type: DIETARY_SUPPLEMENT

omega3 received 2 times daily-for 6 months

scaling and root planing

Intervention Type: PROCEDURE

control group

scaling and root planing placebo soft gelatin capsules 2 times daily-for 6 months

Group Type: PLACEBO_COMPARATOR

scaling and root planing

Intervention Type: PROCEDURE

placebo soft gelatin capsules

Intervention Type: OTHER

placebo soft gelatin capsules received 2 times daily-for 6 months

Interventions

Omega 3 fatty acids

omega3 received 2 times daily-for 6 months

Intervention Type: DIETARY_SUPPLEMENT

scaling and root planing

Intervention Type: PROCEDURE

placebo soft gelatin capsules

placebo soft gelatin capsules received 2 times daily-for 6 months

Intervention Type: OTHER

Other Intervention Names

omega 3

Eligibility Criteria

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).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Enas Elgendy

Ass. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enas A Elgendy, MD

Role: PRINCIPAL_INVESTIGATOR

October University

Other Identifiers

3

Identifier Type: -

Identifier Source: org_study_id