Effect of Omega 3 on Periodontitis in Postmenopausal Women

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764879
• Other study ID #: 3
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2016
• Last updated: May 5, 2016
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2016
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Dietary Supplement:
• Omega 3 fatty acids
omega3 received 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Plaque Index	plaque index was recorded at baseline and at 3 and 6 months post treatment.	up to 6 months	Yes
Secondary	Gingival index	Gingival index was recorded at baseline, 3, 6 months post treatment	up to 6 months	Yes
Secondary	Probing pocket depth	Probing pocket depth in mm was recorded at baseline, 3, 6 months treatment	up to 6 months	Yes
Secondary	Clinical attachment level	Clinical attachment level was recorded at baseline, 3 and 6 months post treatment	up to 6 months	Yes