Effect of Omega 3 on Periodontitis in Postmenopausal Women

Effect of Omega 3 Fatty Acids on Chronic Periodontitis Patients in Postmenopausal Women: A Randomized Controlled Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Dietary supplement: Omega 3 fatty acids; Procedure: scaling and root planing; Other: placebo soft gelatin capsules

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: omega 3 group; scaling and root planing omega3 received 2 times daily-for 6 months	Dietary supplement: Omega 3 fatty acids; omega3 received 2 times daily-for 6 months; Other Names: omega 3; Procedure: scaling and root planing
Placebo Comparator: control group; scaling and root planing placebo soft gelatin capsules 2 times daily-for 6 months	Procedure: scaling and root planing; Other: placebo soft gelatin capsules; placebo soft gelatin capsules received 2 times daily-for 6 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: October 6 University
• Investigators: Principal Investigator: Enas A Elgendy, MD, October University

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Estimate): May 6, 2016
• Last Update Submitted That Met QC Criteria: May 5, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Omega 3 fatty acids; Root planning; chronic periodontitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No