| CTRI Number |
CTRI/2025/01/079047 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Occlusal Reduction on Pain Following Root Canal Treatment in Lower Molars |
|
Scientific Title of Study
|
Role of Occlusal Reduction on Post-operative Pain Following Single Visit Root Canal Treatment in Mandibular Molars |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sathvika K |
| Designation |
Post Graduate Student |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Room no. 6, Department of Conservative Dentistry and Endodontics, 129, East Veli Street, CSI College of Dental Sciences and Research, Madurai.
Madurai
TAMIL NADU
625001
India |
| Phone |
7708197871 |
| Fax |
|
| Email |
drsathvika.kan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of Operative Dentistry and Endodontics |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Room no. 6, Department of Conservative Dentistry and Endodontics, 129, East Veli Street, CSI College of Dental Sciences and Research, Madurai.
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of Operative Dentistry and Endodontics |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Room no. 6, Department of Conservative Dentistry and Endodontics, 129, East Veli Street, CSI College of Dental Sciences and Research, Madurai.
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
|
Source of Monetary or Material Support
|
| (Self) Room no. 6, Department of Conservative Dentistry and Endodontics, 129, East Veli Street, CSI College of Dental Sciences and Research, Madurai, Tamil Nadu, India.
Pincode - 625001. |
|
|
Primary Sponsor
|
| Name |
Sathvika K |
| Address |
(Self) Room no. 6, Department of Conservative Dentistry and Endodontics, 129, East Veli Street, CSI College of Dental Sciences and Research, Madurai, Tamil Nadu, India.
Pincode - 625002. |
| Type of Sponsor |
Other [(Self)] |
|
|
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 |
| Sathvika K |
CSI College of Dental Sciences and Research |
Room no. 6, Department of Conservative Dentistry and Endodontics, 129, East Veli Street, CSI College of Dental Sciences and Research, Madurai, Tamil Nadu, India. Pincode: 625001.
Madurai
TAMIL NADU |
7708197871
drsathvika.kan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee and Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Occlusal Reduction |
Single visit root canal in mandibular molars without occlusal reduction. |
| Intervention |
Occlusal Reduction |
Single visit root canal in mandibular molars with occlusal reduction.
Frequency - Once.
Duration - Few seconds. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
(1)Systemically healthy adult patients
(2)Age group: 18-70 years
(3)Patients with both asymptomatic and symptomatic irreversible pulpitis in mandibular first and second molars who are willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
(1)Re-RCTs
(2)Teeth with additional roots or canal variations
(3)Patients with an allergy to lignocaine
(4)Patients who took analgesics/anti-inflammatories before root canal treatment
(5)Patients with pre-existing absence of occlusal contacts
(6)Patients with bruxism and other para-functional habits contributing to disproportionate occlusal loads |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of postoperative pain following single-visit root canal treatment in mandibular molars with irreversible pulpitis - with and without occlusal reduction. |
24 hours, 48 hours, 1 week following root canal treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the role of different categories of preoperative pain scores and the effect of occlusal reduction on it. |
24 hours, 48 hours, 1 week following root canal treatment |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
Final Enrollment numbers achieved (Total)= "280"
Final Enrollment numbers achieved (India)="280" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study aims to compare the incidence of postoperative pain following single-visit root canal treatment in mandibular molars with irreversible pulpitis - with and without occlusal reduction in various sub-gradients of preoperative pain. |