Omega-3 and Aspirin in Periodontal Regeneration
PR
The Effect of Host Response Modulation Therapy (Omega 3 Plus Low-dose Aspirin) as an Adjunctive Treatment of Chronic Periodontitis (Clinical and Biochemical Study)
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 23, 2010
CompletedFirst Posted
Study publicly available on registry
April 30, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedMay 14, 2010
May 1, 2010
1 month
April 23, 2010
May 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cytokine levels
Interleukin-1 beta Interleukin-10
six months
Secondary Outcomes (2)
Gingival inflammation
six months
Healing after regenerative therapy
six months
Study Arms (2)
Regenerative therapy
EXPERIMENTALSugar pill
PLACEBO COMPARATORInterventions
Comparison between regenerative bone graft alone and bone graft + Omega-3 and low dose aspirin
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- October 6 Universitylead
- Cairo Universitycollaborator
Study Sites (1)
October 6 University
Cairo, Overnorate of 6 October, part 1/1, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amr M. Elkhouli, ph.D
October 6 University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 23, 2010
First Posted
April 30, 2010
Study Start
November 1, 2009
Primary Completion
December 1, 2009
Study Completion
May 1, 2010
Last Updated
May 14, 2010
Record last verified: 2010-05