Omega-3 and Aspirin in Periodontal Regeneration

Study Overview
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Brief Summary
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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
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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.

Official Title
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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
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Periodontal Disease

Intervention / Treatment
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* Other: Regenerative therapy (omega 3 PUFA plus low dose aspirin)
* Drug: Sugar pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regenerative therapy<br> | Other: Regenerative therapy (omega 3 PUFA plus low dose aspirin)<br>* Comparison between regenerative bone graft alone and bone graft + Omega-3 and low dose aspirin<br>* Other names: DFDBA;|
| Placebo Comparator: Sugar pill<br> | Drug: Sugar pill<br>* 3 times daily<br>* Other names: Gelatinous capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine levels | Interleukin-1 beta Interleukin-10 | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival inflammation | plaque index Gingival index Gingival bleeding index | six months | 
| Healing after regenerative therapy | Probing pocket depth Clinical attachment level | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone allograft, IL-1, IL-10, periodontal regeneration, omega-3, aspirin