Omega-3 and Aspirin in Periodontal Regeneration | NCT01113528

Studies
Omega-3 and Aspirin in Periodontal Regeneration

NCT01113528

Sponsor

October 6 University

Status

Completed

Last Update Posted

May 14, 2010Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Periodontal Disease

Interventions

Regenerative therapy (omega 3 PUFA plus low dose aspirin)
Sugar pill

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
October 6 U 196222	Other Identifier	October 6 University

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Dec 2009Actual

Completion Date

May 2010Actual

First Submitted Date

Apr 23, 2010

First Submission Date that Met QC Criteria

Apr 29, 2010

First Posted Date

Apr 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2010

Last Update Posted Date

May 14, 2010Estimated

Name	Class
Cairo University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regenerative therapy	Experimental		Other: Regenerative therapy (omega 3 PUFA plus low dose aspirin)
Sugar pill	Placebo Comparator		Drug: Sugar pill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regenerative therapy (omega 3 PUFA plus low dose aspirin)	Other	Comparison between regenerative bone graft alone and bone graft + Omega-3 and low dose aspirin	Regenerative therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amr M. Elkhouli, ph.D	October 6 University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
October 6 University		Cairo	Overnorate of 6 October	part 1/1	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001241	Aspirin
D005395	Fish Oils
D000073893	Sugars

Ancestor Terms

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided