NCT06270693

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

January 13, 2024

Last Update Submit

February 13, 2024

Conditions

Apical PeriodontitisCoronary Artery Disease

Keywords

apical periodontitiscoronary artery disease

Outcome Measures

Primary Outcomes (2)

  • Serum hsCRP

    Systemic inflammatory burden assessed

    12 months

  • complete hemogram indices

    Systemic inflammatory burden assessed

    12 months

Secondary Outcomes (1)

  • Periapical index SCORE CHANGE

    12 months

Study Arms (2)

CAD WITH AP

EXPERIMENTAL

CORONARY ARTERY DISEASE WITH APICAL PERIODONTITIS

Procedure: Endodontic treatment

CAD WITHOUT AP

NO INTERVENTION

CORONARY ARTERY DISEASE WITHOUT AP

Interventions

Endodontic treatmentPROCEDURE

Root canal treatment

CAD WITH AP

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary artery disease patients with and without chronic pulp exposure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periapical PeriodontitisCoronary Artery Disease

Interventions

Endodontics

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • DR SANJAY TEWARI, MDS

    Post Graduate Institute Of Dental Sciences,Rohtak

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2024

First Posted

February 21, 2024

Study Start

November 1, 2022

Primary Completion

February 1, 2024

Study Completion

April 1, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations

IN(1)