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Omega-3 and Aspirin in Periodontal Regeneration (PR)

This study has been completed.
Cairo University
Information provided by:
October 6 University Identifier:
First received: April 23, 2010
Last updated: May 13, 2010
Last verified: May 2010
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.

Condition Intervention Phase
Periodontal Disease Other: Regenerative therapy (omega 3 PUFA plus low dose aspirin) Drug: Sugar pill Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

Further study details as provided by October 6 University:

Primary Outcome Measures:
  • Cytokine levels [ Time Frame: six months ]
    Interleukin-1 beta Interleukin-10

Secondary Outcome Measures:
  • Gingival inflammation [ Time Frame: six months ]
    plaque index Gingival index Gingival bleeding index

  • Healing after regenerative therapy [ Time Frame: six months ]
    Probing pocket depth Clinical attachment level

Enrollment: 40
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Omega
  • Fish oil
  • ASA
  • low dose aspirin
Placebo Comparator: Sugar pill Drug: Sugar pill
3 times daily
Other Name: Gelatinous capsules

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.

Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01113528

October 6 University
Cairo, Overnorate of 6 October, Egypt, part 1/1
Sponsors and Collaborators
October 6 University
Cairo University
Principal Investigator: Amr M. Elkhouli, ph.D October 6 University
  More Information

Responsible Party: Amr Moustafa Elkhouli, Lecturer, O6U Identifier: NCT01113528     History of Changes
Other Study ID Numbers: HHDA-1962
October 6 U 196222 ( Other Identifier: October 6 University )
Study First Received: April 23, 2010
Last Updated: May 13, 2010

Keywords provided by October 6 University:
Bone allograft
periodontal regeneration

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics processed this record on August 18, 2017