NCT02764879

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

May 3, 2016

Last Update Submit

May 5, 2016

Conditions

Chronic Periodontitis

Keywords

Omega 3 fatty acidsRoot planningchronic periodontitis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Plaque Index

    up to 6 months

  • Gingival index

    up to 6 months

  • Probing pocket depth

    up to 6 months

  • Clinical attachment level

    up to 6 months

Study Arms (2)

omega 3 group

EXPERIMENTAL

scaling and root planing omega3 received 2 times daily-for 6 months

Dietary Supplement: Omega 3 fatty acidsProcedure: scaling and root planing

control group

PLACEBO COMPARATOR

scaling and root planing placebo soft gelatin capsules 2 times daily-for 6 months

Procedure: scaling and root planingOther: placebo soft gelatin capsules

Interventions

Omega 3 fatty acidsDIETARY_SUPPLEMENT

omega3 received 2 times daily-for 6 months

Also known as: omega 3
omega 3 group
scaling and root planingPROCEDURE
control groupomega 3 group
placebo soft gelatin capsulesOTHER

placebo soft gelatin capsules received 2 times daily-for 6 months

control group

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Fatty Acids, Omega-3Docosahexaenoic AcidsTooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Enas A Elgendy, MD

    October University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 6, 2016

Study Start

July 1, 2014

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

May 6, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share