Skip to main content
OpenTrials
Completed

NCT Number: NCT02764879

Effect of Omega 3 on Periodontitis in Postmenopausal Women

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

omega 3 fatty acids

Dietary Supplement

omega3 received 2 times daily-for 6 months

Other names: omega 3

Scaling and Root Planing

Procedure

placebo soft gelatin capsules

Other

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

Primary outcomes

  1. superoxide dismutase (SOD) activity in the gingival crevicular fluid

    Time frame: up to 6 months

    Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 3 and 6 months post treatment.

Secondary outcomes

  1. Plaque Index

    Time frame: up to 6 months

    plaque index was recorded at baseline and at 3 and 6 months post treatment.

  2. Gingival index

    Time frame: up to 6 months

    Gingival index was recorded at baseline, 3, 6 months post treatment

  3. Probing pocket depth

    Time frame: up to 6 months

    Probing pocket depth in mm was recorded at baseline, 3, 6 months treatment

  4. Clinical attachment level

    Time frame: up to 6 months

    Clinical attachment level was recorded at baseline, 3 and 6 months post treatment

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 6, 2016
Registry last updated
May 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.