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NCT Number: NCT01113528

Omega-3 and Aspirin in Periodontal Regeneration

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.

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Key information

Conditions

Periodontal Disease Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

October 6 University

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regenerative therapy (omega 3 PUFA plus low dose aspirin)

Other

Comparison between regenerative bone graft alone and bone graft + Omega-3 and low dose aspirin

Other names: Omega, Fish oil, ASA, low dose aspirin, DFDBA

Sugar pill

Drug

3 times daily

Other names: Gelatinous capsules

Primary outcomes

  1. Cytokine levels

    Time frame: six months

    Interleukin-1 beta Interleukin-10

Secondary outcomes

  1. Gingival inflammation

    Time frame: six months

    plaque index Gingival index Gingival bleeding index

  2. Healing after regenerative therapy

    Time frame: six months

    Probing pocket depth Clinical attachment level

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Acronym: PR

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Apr 30, 2010
Registry last updated
May 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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