Effect of Omega 3 on Periodontitis in Postmenopausal Women

October 6 University

Status and phase: Completed; Phase 2

Conditions: Chronic Periodontitis

Treatments: Procedure: scaling and root planing; Dietary Supplement: Omega 3 fatty acids; Other: placebo soft gelatin capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT02764879

3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

omega 3 group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Omega 3 fatty acids

Procedure: scaling and root planing

control group

Placebo Comparator group

Description:

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

Treatment:

Other: placebo soft gelatin capsules

Procedure: scaling and root planing