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Effect of Omega 3 on Periodontitis in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT02764879
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : May 6, 2016
Sponsor:
Information provided by (Responsible Party):
Enas Elgendy, October 6 University

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Dietary Supplement: Omega 3 fatty acids Procedure: scaling and root planing Other: placebo soft gelatin capsules Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Omega 3 Fatty Acids on Chronic Periodontitis Patients in Postmenopausal Women: A Randomized Controlled Clinical Study
Study Start Date : July 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764879


Sponsors and Collaborators
October 6 University
Investigators
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Principal Investigator: Enas A Elgendy, MD October University

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Responsible Party: Enas Elgendy, Ass. Prof., October 6 University
ClinicalTrials.gov Identifier: NCT02764879     History of Changes
Other Study ID Numbers: 3
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Enas Elgendy, October 6 University:
Omega 3 fatty acids
Root planning
chronic periodontitis

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases