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Omega-3 and Aspirin in Periodontal Regeneration (PR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01113528
First Posted: April 30, 2010
Last Update Posted: May 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cairo University
Information provided by:
October 6 University
  Purpose
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
  • DFDBA
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.
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113528


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

Responsible Party: Amr Moustafa Elkhouli, Lecturer, O6U
ClinicalTrials.gov Identifier: NCT01113528     History of Changes
Other Study ID Numbers: HHDA-1962
October 6 U 196222 ( Other Identifier: October 6 University )
First Submitted: April 23, 2010
First Posted: April 30, 2010
Last Update Posted: May 14, 2010
Last Verified: May 2010

Keywords provided by October 6 University:
Bone allograft
IL-1
IL-10
periodontal regeneration
omega-3
aspirin

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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