| CTRI Number |
CTRI/2025/11/097854 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Do Root Canal Sealers Cause Pain After Treatment? A Clinical Trial Comparing Three Sealers |
|
Scientific Title of Study
|
Comparative Evaluation Of Post Operative Pain On Unintentional Extrusion Of Three Different Root Canal Sealers Periapically: A Ramdomised Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuj Bhardwaj |
| Designation |
Professor and Head |
| Affiliation |
College of Dental Sciences & Hospital |
| Address |
Department of Conservative Dentistry and Endodontics College of Dental Sciences and Hospital Rau Indore
Indore
MADHYA PRADESH
453331
India |
| Phone |
7898540222 |
| Fax |
|
| Email |
dranuj_84@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuj Bhardwaj |
| Designation |
Professor and Head |
| Affiliation |
College of Dental Sciences & Hospital |
| Address |
Department of Conservative Dentistry and Endodontics College of Dental Sciences and Hospital Rau Indore
Indore
MADHYA PRADESH
453331
India |
| Phone |
7898540222 |
| Fax |
|
| Email |
dranuj_84@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Anuj Bhardwaj |
| Designation |
Professor and Head |
| Affiliation |
College of Dental Sciences & Hospital |
| Address |
Department of Conservative Dentistry and Endodontics College of Dental Sciences and Hospital Rau Indore
Indore
MADHYA PRADESH
453331
India |
| Phone |
7898540222 |
| Fax |
|
| Email |
dranuj_84@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anuj Bhardwaj |
| Address |
Department of Conservative Dentistry and Endodontics, College of Dental Sciences & Hospital, Rau, Indore 453331, India |
| 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 |
| Anuj Bhardwaj |
College of Dental Science and Hospital |
Department of Conservative Dentistry and Endodontics, Room No 201, Second Floor, F 12 Jhoomer Ghat Rau
Indore
MADHYA PRADESH |
78985 40222
dranuj_84@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of College of Dental Sciences and Hospital Indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 Biceramic Sealer |
The single visit root canal treatment will be done and after cleaning and shaping the root canals will be obdurated with bioceramic sealer. |
| Intervention |
Group 2 MTA based sealer |
The single visit root canal treatment will be done and after cleaning and shaping the root canals will be obdurated with MTA based sealer. |
| Comparator Agent |
Group 3 Resin Based Sealer |
The single visit root canal treatment will be done and after cleaning and shaping the root canals will be obdurated with Resin based sealer. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Two hundred consecutive patients aged 18–65 years will be screened for eligibility. Participants with a clinical diagnosis of symptomatic irreversible pulpitis, with or without clinical signs of apical periodontitis, involving a maxillary or mandibular first molar with fully developed roots and no radiographic evidence of a periapical lesion will be included. Pulp sensibility will be assessed using a cold test (Endo-Ice, Hygienic, Akron, OH, USA) and an electric pulp tester. A preoperative periapical radiograph will be obtained using radiovisiography (RVG; Vatech India, New Delhi, India). |
|
| ExclusionCriteria |
| Details |
Non-vital teeth—defined as a negative response to thermal stimulation (with Endo-Ice) and verified by the absence of bleeding in the access cavity preparation (see below)—will be one exclusion criterion. Prior endodontic retreatment, second or third molars, or teeth with a specific intent for root canal treatment will be excluded. Teeth with periapical radiolucency, root resorption, immature or open apices, root caries, or extensive structural loss decided non-restorable will be excluded. Teeth exhibiting pathologic mobility, complex root anatomy, and patient-related exclusion criteria will also be excluded. Participants who do not wish to comply, those who have taken analgesics and/or anti-inflammatories (steroidal or nonsteroidal) within the prior twelve hours, pregnant or breastfeeding individuals, those with uncontrolled systemic disease, and participants outside the trial’s adult age range (younger than eighteen years or older than sixty-five years) will be excluded as part of the exclusion criteria. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The main outcome will be the severity of postoperative pain, measured on a visual analogue scale (VAS) ranging from 0-100 millimetres. Patients will be given a take-home VAS to help the outcome assessor obtain postoperative pain levels in their questionnaires. |
Immediate
12 hours
24 hours
72 hours
and
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of postoperative flare-up—defined as severe pain and/or swelling requiring unscheduled care or intra-canal intervention. |
Seven days after treatment. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/12/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 clinical trial will investigate postoperative pain associated with unintentional periapical extrusion of three types of root canal sealers: a bioceramic, an MTA-based, and a resin-based sealer. Adult patients will be enrolled for primary endodontic treatment of first molars that could be completed in single visit. After providing informed consent, patients will be randomized to a parallel group using concealed allocation. Clinicians will be blinded to the randomization assignment while completing the protocol. Each patient will receive treatment consisting of consistent, obturation by warm vertical compaction to a standardized size. If sealer extrusion occurs, it will be documented via radiograph. The primary outcome will be postoperative pain, assessed on a 100-mm visual analog scale at 6, 24, 48, and 72 hours after treatment. Secondary outcomes will include the analgesics taken, flare-ups, and visits to urgent care. Intention-to-treat analyses will compare pain trajectories and peak pain using mixed models and contrasts across groups. In total, this study aims to determine whether differences in sealer chemistry will have a significant impact on early postoperative pain if periapical extrusion occurs and provide further consideration on sealers most appropriate for patient comfort and clinical utility. |