Clinical trial NCT02764879: Effect of Omega 3 on Periodontitis in Postmenopausal Women
Official title: Effect of Omega 3 Fatty Acids on Chronic Periodontitis Patients in Postmenopausal Women: A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Periodontitis
Keywords: Omega 3 fatty acids
Root planning
chronic periodontitis
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: superoxide dismutase (SOD) activity in the gingival crevicular fluid
timeFrame: up to 6 months
Secondary outcomes:
measure: Plaque Index
timeFrame: up to 6 months
measure: Gingival index
timeFrame: up to 6 months
measure: Probing pocket depth
timeFrame: up to 6 months
measure: Clinical attachment level
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: October University
name: Enas A Elgendy, MD
role: PRINCIPAL_INVESTIGATOR
References: