Omega-3 and Aspirin in Periodontal Regeneration

Phase 2

Completed

• Conditions: Periodontal Disease
• Interventions: Other: Regenerative therapy (omega 3 PUFA plus low dose aspirin); Drug: Sugar pill

• Registration Number: NCT01113528
• Lead Sponsor: October 6 University

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 Timeline

• Study Start: 2009-11
• Primary Completion: 2009-12
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-29
• Study First Posted: 2010-04-30
• Status Verified: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2010-05-13
• Last Update Posted: 2010-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regenerative therapy	Regenerative therapy (omega 3 PUFA plus low dose aspirin)	-
Sugar pill	Sugar pill	-

Primary Outcome Measures

Name	Time	Method
Cytokine levels	six months	Interleukin-1 beta Interleukin-10

Secondary Outcome Measures

Name	Time	Method
Gingival inflammation	six months	plaque index Gingival index Gingival bleeding index
Healing after regenerative therapy	six months	Probing pocket depth Clinical attachment level

Trial Locations

Locations (1)

October 6 University; 🇪🇬 Cairo, Overnorate of 6 October, Egypt