Apical PeriodontitisNCT06270693
hsCRP & CH Indices in Patients With Coronary Artery Disease With and Without Apical Periodontitis
A study testing Endodontic treatment in people with Apical Periodontitis and Coronary Artery Disease, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Apical Periodontitis, Coronary Artery Disease
- What is being tested?
- Endodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary artery disease patients with and without chronic pulp exposure
Who cannot join
- Other systemic diseases
- Antibiotics for More than 1 month
- Smoking
- Analgesics more than 1 week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Endodontic Treatment on Serum High Sensitivity C-reactive Protein and Complete Hemogram Indices in Patients With Cardiovascular Disease With and Without Apical Periodontitis: A Prospective Interventional Study
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.
Read the detailed description
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. Systemic inflammatory burden is assessed before and after endodontic treatment.
- Conditions
- Apical Periodontitis, Coronary Artery Disease
- Being tested
- Endodontic treatment
- Keywords
- apical periodontitis, coronary artery disease
- Medical subject headings
- Periapical Periodontitis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic treatmentProcedure or surgery
Root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| CAD WITH AP | Experimental | CORONARY ARTERY DISEASE WITH APICAL PERIODONTITIS Receives: Procedure: Endodontic treatment |
| CAD WITHOUT AP | No intervention | CORONARY ARTERY DISEASE WITHOUT AP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum hsCRP
Systemic inflammatory burden assessed
Measured: 12 months
complete hemogram indices
Systemic inflammatory burden assessed
Measured: 12 months
Secondary outcomes (1)
Periapical index SCORE CHANGE
1-5 ordinal scale,5 worse outconpme \& HEALING ASSESSED
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Nov 2022
- Primary completion1 Feb 2024
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DR SANJAY TEWARI, MDS, Study director, Post Graduate Institute Of Dental Sciences,Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270693
- Sponsor's protocol ID
- Dr Sushma
- Status last verified
- Feb 2024
- First submitted
- 13 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endodontic Treatment on Serum High Sensitivity C-reactive Protein and Complete Hemogram Indices in Patients With Cardiovascular Disease With and Without Apical Periodontitis: A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT06270693
- Acronym / sponsor ID
- Dr Sushma
- Conditions
- Apical Periodontitis, Coronary Artery Disease
- Keywords
- apical periodontitis, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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. Systemic inflammatory burden is assessed before and after endodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD WITH AP | Experimental | Procedure: Endodontic treatmentCORONARY ARTERY DISEASE WITH APICAL PERIODONTITIS |
| CAD WITHOUT AP | No intervention | –CORONARY ARTERY DISEASE WITHOUT AP |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Coronary artery disease patients with and without chronic pulp exposure
Key exclusion criteria (4 listed)
- Other systemic diseases
- Antibiotics for More than 1 month
- Smoking
- Analgesics more than 1 week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endodontic treatmentRoot canal treatment | Procedure or surgery | CAD WITH AP |
Primary outcome
Serum hsCRP
Time frame: 12 months
Systemic inflammatory burden assessed
complete hemogram indices
Time frame: 12 months
Systemic inflammatory burden assessed
1 secondary outcome
Periapical index SCORE CHANGE
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DR SANJAY TEWARI, MDS study director
Post Graduate Institute Of Dental Sciences,Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic treatment in people with Apical Periodontitis and Coronary Artery Disease, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum hsCRP (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.