Back to resultsEffect of Omega 3 on Periodontitis in Postmenopausal Women
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Omega 3 fatty acids
scaling and root planing
placebo soft gelatin capsules
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Omega 3 fatty acids, Root planning, chronic periodontitis
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
omega 3 group
control group
Arm Description
scaling and root planing omega3 received 2 times daily-for 6 months
scaling and root planing placebo soft gelatin capsules 2 times daily-for 6 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Plaque Index
plaque index was recorded at baseline and at 3 and 6 months post treatment.
Gingival index
Gingival index was recorded at baseline, 3, 6 months post treatment
Probing pocket depth
Probing pocket depth in mm was recorded at baseline, 3, 6 months treatment
Clinical attachment level
Clinical attachment level was recorded at baseline, 3 and 6 months post treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02764879
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Omega 3 fatty acids, Root planning, chronic periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
omega 3 group
Arm Type
Experimental
Arm Description
scaling and root planing omega3 received 2 times daily-for 6 months
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
scaling and root planing placebo soft gelatin capsules 2 times daily-for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega 3 fatty acids
Other Intervention Name(s)
omega 3
Intervention Description
omega3 received 2 times daily-for 6 months
Intervention Type
Procedure
Intervention Name(s)
scaling and root planing
Intervention Type
Other
Intervention Name(s)
placebo soft gelatin capsules
Intervention Description
placebo soft gelatin capsules received 2 times daily-for 6 months
Primary Outcome Measure Information:
Title
superoxide dismutase (SOD) activity in the gingival crevicular fluid
Description
Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 3 and 6 months post treatment.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Plaque Index
Description
plaque index was recorded at baseline and at 3 and 6 months post treatment.
Time Frame
up to 6 months
Title
Gingival index
Description
Gingival index was recorded at baseline, 3, 6 months post treatment
Time Frame
up to 6 months
Title
Probing pocket depth
Description
Probing pocket depth in mm was recorded at baseline, 3, 6 months treatment
Time Frame
up to 6 months
Title
Clinical attachment level
Description
Clinical attachment level was recorded at baseline, 3 and 6 months post treatment
Time Frame
up to 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enas A Elgendy, MD
Organizational Affiliation
October University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Omega 3 on Periodontitis in Postmenopausal Women
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