Back to resultsOmega-3 and Aspirin in Periodontal Regeneration (PR)
Primary Purpose
Periodontal Disease
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Regenerative therapy (omega 3 PUFA plus low dose aspirin)
Sugar pill
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Disease focused on measuring Bone allograft, IL-1, IL-10, periodontal regeneration, omega-3, aspirin
Eligibility 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
Sites / Locations
- October 6 University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Regenerative therapy
Sugar pill
Arm Description
Outcomes
Primary Outcome Measures
Cytokine levels
Interleukin-1 beta Interleukin-10
Secondary Outcome Measures
Gingival inflammation
plaque index Gingival index Gingival bleeding index
Healing after regenerative therapy
Probing pocket depth Clinical attachment level
Full Information
NCT ID
NCT01113528
First Posted
April 23, 2010
Last Updated
May 13, 2010
Sponsor
October 6 University
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT01113528
Brief Title
Omega-3 and Aspirin in Periodontal Regeneration
Acronym
PR
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
October 6 University
Collaborators
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
Keywords
Bone allograft, IL-1, IL-10, periodontal regeneration, omega-3, aspirin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regenerative therapy
Arm Type
Experimental
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Regenerative therapy (omega 3 PUFA plus low dose aspirin)
Other Intervention Name(s)
Omega, Fish oil, ASA, low dose aspirin, DFDBA
Intervention Description
Comparison between regenerative bone graft alone and bone graft + Omega-3 and low dose aspirin
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Other Intervention Name(s)
Gelatinous capsules
Intervention Description
3 times daily
Primary Outcome Measure Information:
Title
Cytokine levels
Description
Interleukin-1 beta Interleukin-10
Time Frame
six months
Secondary Outcome Measure Information:
Title
Gingival inflammation
Description
plaque index Gingival index Gingival bleeding index
Time Frame
six months
Title
Healing after regenerative therapy
Description
Probing pocket depth Clinical attachment level
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr M. Elkhouli, ph.D
Organizational Affiliation
October 6 University
Official's Role
Principal Investigator
Facility Information:
Facility Name
October 6 University
City
Cairo
State/Province
Overnorate of 6 October
ZIP/Postal Code
part 1/1
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Omega-3 and Aspirin in Periodontal Regeneration
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