NCT01113528CompletedPhase 2
The Effect of Host Response Modulation Therapy (Omega 3 Plus Low-dose Aspirin) as an Adjunctive Treatment of Chronic Periodontitis (Clinical and Biochemical Study)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- October 6 University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Cytokine levels
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 35 Years to 60 Years (Adult)
- Sex
- 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
Arms & Interventions
Regenerative therapy
Experimental
Intervention: Regenerative therapy (omega 3 PUFA plus low dose aspirin) (Other)
Sugar pill
Placebo Comparator
Intervention: Sugar pill (Drug)
Outcomes
Primary Outcomes
Cytokine levels
Time Frame: six months
Interleukin-1 beta Interleukin-10
Secondary Outcomes
- Gingival inflammation(six months)
- Healing after regenerative therapy(six months)
Investigators
Study Sites (1)
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