Omega-3 and Aspirin in Periodontal Regeneration (PR)

May 13, 2010 updated by: October 6 University

The Effect of Host Response Modulation Therapy (Omega 3 Plus Low-dose Aspirin) as an Adjunctive Treatment of Chronic Periodontitis (Clinical and Biochemical Study)

To evaluate the efficacy of systemic administration of omega 3 PUFA plus low dose aspirin as an adjunctive therapy to regenerative modality of grade II furcation defects in periodontitis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, we tested the hypothesis that the administration of omega 3 PUFA plus low dose aspirin would augment the results following regenerative therapy of furcation defects in chronic periodontitis patients.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Overnorate of 6 October
      • Cairo, Overnorate of 6 October, Egypt, part 1/1
        • October 6 University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • suffering moderate to sever chronic periodontitis and displaying at least a single grade II furcation defect according to Glickman's classification 1953, determined by both clinical and radiographic examinations;
  • free from systemic diseases known to influence the periodontal condition and not receiving any medication known to affect the periodontal status;
  • have not receive any periodontal therapy for a minimum of 6 months prior to the study.

Exclusion Criteria:

  • Known hypersensitivity or allergy to one of the used medications
  • Pregnancy or lactation
  • Heavy smoking (more than 10cigarretes/day)
  • History of alcohol abuse
  • Participation in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sugar pill
Drug: Sugar pill
3 times daily
Other Names:
  • Gelatinous capsules
Experimental: Regenerative therapy
Other: Regenerative therapy (omega 3 PUFA plus low dose aspirin)
Comparison between regenerative bone graft alone and bone graft + Omega-3 and low dose aspirin
Other Names:
  • ASA
  • Fish oil
  • DFDBA
  • Omega
  • low dose aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokine levels
Time Frame: six months
Interleukin-1 beta Interleukin-10
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival inflammation
Time Frame: six months
plaque index Gingival index Gingival bleeding index
six months
Healing after regenerative therapy
Time Frame: six months
Probing pocket depth Clinical attachment level
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Collaborators

Cairo University

Investigators

  • Principal Investigator: Amr M. Elkhouli, ph.D, October 6 University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 29, 2010

First Posted (Estimate)

April 30, 2010

Study Record Updates

Last Update Posted (Estimate)

May 14, 2010

Last Update Submitted That Met QC Criteria

May 13, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHDA-1962
  • October 6 U 196222 (Other Identifier: October 6 University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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