Omega-3 and Aspirin in Periodontal Regeneration

Periodontal Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113528
• Other study ID #: HHDA-1962
• Secondary ID: October 6 U 1962
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2010
• Last updated: May 13, 2010
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Other:
• Regenerative therapy (omega 3 PUFA plus low dose aspirin)
Comparison between regenerative bone graft alone and bone graft + Omega-3 and low dose aspirin

Drug:
• Sugar pill
3 times daily

Locations

Country	Name	City	State
Egypt	October 6 University	Cairo	Overnorate of 6 October

Sponsors (2)

Lead Sponsor	Collaborator
October 6 University	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine levels	Interleukin-1 beta Interleukin-10	six months	No
Secondary	Gingival inflammation	plaque index Gingival index Gingival bleeding index	six months	No
Secondary	Healing after regenerative therapy	Probing pocket depth Clinical attachment level	six months	No