| CTRI Number |
CTRI/2025/05/087188 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
How Root Canal Treatment Affects Heart Health and Inflammation in People with Infected Front Teeth |
|
Scientific Title of Study
|
Effect of root canal treatment on hs-CRP levels and non-invasive cardiovascular risk marker in systemically healthy individuals with apical periodontitis of anterior teeth – a prospective clinical study
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Annam Sai Sri Rishi |
| Designation |
Post graduate |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Department of Conservative Dentistry And Endodontics first floor room number 7 Kamineni Institute of Dental Sciences Sreepuram Narketpally Nalgonda District
Nalgonda
TELANGANA
508254
India |
| Phone |
09381240290 |
| Fax |
08682272296 |
| Email |
sairishi27997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayaprada Reddy |
| Designation |
HOD and Professor |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Department of Conservative Dentistry And Endodontics first floor room number 7 Kamineni Institute of Dental Sciences Sreepuram Narketpally Nalgonda District
Nalgonda
TELANGANA
508254
India |
| Phone |
09381240290 |
| Fax |
08682272296 |
| Email |
drsjayapradareddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Annam Sai Sri Rishi |
| Designation |
Post graduate |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Dentistry And Endodontics first floor room number 7 Kamineni Institute of Dental Sciences Sreepuram Narketpally Nalgonda District
Nalgonda
TELANGANA
508254
India |
| Phone |
09381240290 |
| Fax |
08682272296 |
| Email |
sairishi27997@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Kamineni Institute of Dental Sciences |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Annam Sai Sri Rishi |
Kamineni Institute of Dental Sciences |
Department of Conservative Dentistry And Endodontics first floor room number 7 Kamineni Institute of Dental Sciences Sreepuram Narketpally Nalgonda District
Nalgonda
TELANGANA |
09381240290
08682272296
sairishi27997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kamineni Institute of Dental Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients without any systemic diseases who have apical periodontitis of the anterior teeth will be recruited |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High sensitivity C-Reactive Protein and Carotid Artery Intima Media Thickness Levels before root canal treatment |
High sensitivity C-Reactive Protein and Carotid Artery Intima Media Thickness Levels
after root canal treatment at baseline 3 months, and 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals with primary Apical Periodontitis of single rooted anterior teeth associated with
Apical Lesions of Endodontic Origin, and the absence of acute or chronic systemic diseases.
2 Individuals with a single tooth diagnosed with apical periodontitis with no
response to pulp sensibility tests and with a Periapical Index score greater than or equal to 3.
|
|
| ExclusionCriteria |
| Details |
1 Diagnosed non-communicable systemic diseases.
2 Obesity (body mass index (BMI) greater than or equal to 30 kg/m2)
3 Pregnancy
4 Acute infection
5 Smokers
6 Patients with previously endodontically treated teeth with periapical
radiolucencies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in hs-CRP and CIMT levels after root canal treatment |
Decrease in hs-CRP and CIMT levels after 3 months and 6 months of root canal treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="29" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
C-reactive protein (CRP), particularly high-sensitivity CRP (hs-CRP), is a biomarker for systemic inflammation and is associated with various chronic inflammatory conditions. Root canal treatment significantly reduces hs-CRP levels and decreases carotid intimamedia thickness (CIMT) in apical periodontitis patients. AIM OF THE STUDY The aim of present study is to assess the impact of root canal treatment on hs-CRP levels and noninvasive cardiovascular risk marker (CIMT) in systemically healthy adults with apical periodontitis of anterior teeth. OBJECTIVES OF THE STUDY To measure hs-CRP and CIMT levels before and after root canal treatment. To compare hs-CRP and CIMT levels in treated patients with a control group of untreated individuals. Group 1 – Experimental group • Prior to the clinical procedure. Baseline hs CRP and CIMT levels will be recorded from the patient. • The tooth will be isolated with rubber dam following Local anesthesia administration with lignocaine with 1:100, 000 epinephrine • Access cavity will be prepared. • Working length will be determined using electronic apex locator and radiographic confirmation will be taken. • Cleaning and shaping will be done using hand files and Pro-Taper files. • Irrigation with 5 ml of 5.2 % NaOCl will be done after each instrument usage followed by 17 % EDTA and final rinse of saline. • After drying the canals with paper points ,calcium hydroxide paste intracanal medicament will be placed for 7 days • During the second visit, under dental dam isolation ,the calcium hydroxide medicament will be removed by thorough irrigation with saline./ • Then canals will be dried with paper points and filled with gutta percha and AH plus sealer • At the 3-months and 6 months follow up, the teeth will be evaluated clinically and radiographically. and the serum hs CRP levels and, CIMT levels will be measured and correlated with control group. GROUP 2 – Control group • 15 subjects will be selected after matching with group 1 based on age, gender , bmi , geographic area , socioeconomic status without apical periodontitis. • Baseline hs-CRP and CIMT levels will be recorded from the subjects • At the 3-months and 6 months follow up the serum hsCRP levels and CIMT will be measured.
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