Chronic PeriodontitisPhase 2NCT02764879
Effect of Omega 3 on Periodontitis in Postmenopausal Women
A Phase 2 study testing Omega 3 fatty acids and scaling and root planing in people with Chronic Periodontitis, run by October 6 University.
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Omega 3 fatty acids and scaling and root planing
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: Effect of Omega 3 Fatty Acids on Chronic Periodontitis Patients in Postmenopausal Women: A Randomized Controlled Clinical Study
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.
Read the 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.
- Conditions
- Chronic Periodontitis
- Being tested
- Omega 3 fatty acids, scaling and root planing, placebo soft gelatin capsules
- Keywords
- Omega 3 fatty acids, Root planning, chronic periodontitis
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acidsDietary supplement
Also called omega 3
omega3 received 2 times daily-for 6 months
scaling and root planingProcedure or surgery
placebo soft gelatin capsulesOther
placebo soft gelatin capsules received 2 times daily-for 6 months
| Study group | Role | What they receive |
|---|---|---|
| omega 3 group | Experimental | scaling and root planing omega3 received 2 times daily-for 6 months Receives: Dietary Supplement: Omega 3 fatty acids; Procedure: scaling and root planing |
| control group | Placebo comparator | scaling and root planing placebo soft gelatin capsules 2 times daily-for 6 months Receives: Procedure: scaling and root planing; Other: placebo soft gelatin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (4)
Plaque Index
plaque index was recorded at baseline and at 3 and 6 months post treatment.
Measured: up to 6 months
Gingival index
Gingival index was recorded at baseline, 3, 6 months post treatment
Measured: up to 6 months
Probing pocket depth
Probing pocket depth in mm was recorded at baseline, 3, 6 months treatment
Measured: up to 6 months
Clinical attachment level
Clinical attachment level was recorded at baseline, 3 and 6 months post treatment
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startJul 2014
- Primary completionJan 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Elgendy, October 6 University
- Investigators
- Enas A Elgendy, MD, Principal investigator, October University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764879
- Sponsor's protocol ID
- 3
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega 3 Fatty Acids on Chronic Periodontitis Patients in Postmenopausal Women: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02764879
- Acronym / sponsor ID
- 3
- Conditions
- Chronic Periodontitis
- Keywords
- Omega 3 fatty acids, Root planning, chronic periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega 3 group | Experimental | Dietary Supplement: Omega 3 fatty acids, Procedure: scaling and root planingscaling and root planing omega3 received 2 times daily-for 6 months |
| control group | Placebo comparator | Procedure: scaling and root planing, Other: placebo soft gelatin capsulesscaling and root planing placebo soft gelatin capsules 2 times daily-for 6 months |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 fatty acidsAlso: omega 3omega3 received 2 times daily-for 6 months | Dietary supplement | omega 3 group |
| scaling and root planing | Procedure or surgery | control group, omega 3 group |
| placebo soft gelatin capsulesplacebo soft gelatin capsules received 2 times daily-for 6 months | Other | control group |
Primary outcome
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.
4 secondary outcomes
Plaque Index
Time frame: up to 6 months
Gingival index
Time frame: up to 6 months
Probing pocket depth
Time frame: up to 6 months
Clinical attachment level
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Individual participant dataSharing planned: No
Related trials for Chronic Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enas A Elgendy, MD principal investigator
October University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega 3 fatty acids and scaling and root planing in people with Chronic Periodontitis, run by October 6 University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
superoxide dismutase (SOD) activity in the gingival crevicular fluid (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.