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Omega-3 and Aspirin in Periodontal Regeneration (PR)

This study has been completed.
Sponsor:
Collaborator:
Cairo University
Information provided by:
October 6 University
ClinicalTrials.gov Identifier:
NCT01113528
First received: April 23, 2010
Last updated: May 13, 2010
Last verified: May 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by October 6 University:

Primary Outcome Measures:
  • Cytokine levels [ Time Frame: six months ] [ Designated as safety issue: No ]
    Interleukin-1 beta Interleukin-10


Secondary Outcome Measures:
  • Gingival inflammation [ Time Frame: six months ] [ Designated as safety issue: No ]
    plaque index Gingival index Gingival bleeding index

  • Healing after regenerative therapy [ Time Frame: six months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Amr Moustafa Elkhouli, Lecturer, O6U
ClinicalTrials.gov Identifier: NCT01113528     History of Changes
Other Study ID Numbers: HHDA-1962, October 6 U 196222
Study First Received: April 23, 2010
Last Updated: May 13, 2010
Health Authority: Egypt: Institutional Review Board

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

Additional relevant MeSH terms:
Periodontal Diseases
Chronic Periodontitis
Mouth Diseases
Stomatognathic Diseases
Periodontitis
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013