hsCRP & CH Indices in Patients With Coronary Artery Disea... | NCT06270693

Studies
hsCRP & CH Indices in Patients With Coronary Artery Disease With and Without Apical Periodontitis

NCT06270693

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Status

Unknown status

Last Update Posted

Feb 21, 2024Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Apical Periodontitis
Coronary Artery Disease

Interventions

Endodontic treatment

Countries

India

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

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Actual

Primary Completion Date

Feb 1, 2024Actual

Completion Date

Apr 1, 2024Estimated

First Submitted Date

Jan 13, 2024

First Submission Date that Met QC Criteria

Feb 13, 2024

First Posted Date

Feb 21, 2024Actual

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

Feb 13, 2024

Last Update Posted Date

Feb 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Endodontic treatment is done in Patients with chronic pulp exposure in patients with Coronary Artery Disease and systemic inflammatory markers recorded before and and after treatment and compared with patients with Coronary Artery Disease without chronic pulp exposure.

Detailed Description

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CAD WITH AP	Experimental	CORONARY ARTERY DISEASE WITH APICAL PERIODONTITIS	Procedure: Endodontic treatment
CAD WITHOUT AP	No Intervention	CORONARY ARTERY DISEASE WITHOUT AP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endodontic treatment	Procedure	Root canal treatment	CAD WITH AP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum hsCRP	Systemic inflammatory burden assessed	12 months
complete hemogram indices	Systemic inflammatory burden assessed	12 months

Secondary Outcomes

Measure	Description	Time Frame
Periapical index SCORE CHANGE	1-5 ordinal scale,5 worse outconpme & HEALING ASSESSED	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Coronary artery disease patients with and without chronic pulp exposure

Exclusion Criteria:

Other systemic diseases
Antibiotics for More than 1 month
Smoking
Analgesics more than 1 week

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
DR SANJAY TEWARI, MDS	Post Graduate Institute Of Dental Sciences,Rohtak	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PGIDS		Rohtak	Haryana	124001	India

Condition Browse Module

MeSH Terms

ID	Term
D010485	Periapical Periodontitis
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D010483	Periapical Diseases
D007571	Jaw Diseases
D009057	Stomatognathic Diseases
D010510	Periodontal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided