Effect of Omega 3 on Periodontitis in Postmenopausal Women

O

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

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems