| CTRI Number |
CTRI/2026/01/102592 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of Pain after Root Canal Treatment In Symptom free Non-vital Mandibular Premolars, Using Two Different Types Of Root Canal Sealers: A Randomized Clinical Study. |
|
Scientific Title of Study
|
Comparative Evaluation Of Postoperative Pain In Asymptomatic Non-vital Mandibular Premolars Using Bioceramic And Resin Based Root Canal sealers: A Randomized 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 |
Dr Aviral Singhal |
| Designation |
MDS 3rd year |
| Affiliation |
J N Kapoor DAV Dental College, Yamunanagar |
| Address |
Department Of Conservative Dentistry and Endodontics, Room no 3
Yamunanagar
HARYANA
135001
India |
| Phone |
7400298409 |
| Fax |
|
| Email |
aviralsinghal119@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Bogra |
| Designation |
Professor and head of the Department |
| Affiliation |
J N Kapoor DAV Dental College, Yamunanagar |
| Address |
Department of Conservative Dentistry and Endodontics, Room no 3
Yamunanagar
HARYANA
135001
India |
| Phone |
9050462962 |
| Fax |
|
| Email |
poonambogra@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aviral Singhal |
| Designation |
MDS 3rd yr |
| Affiliation |
J N Kapoor DAV Dental College, Yamunanagar |
| Address |
Department of Conservative Dentistry and Endodontics, Room no 3
Yamunanagar
HARYANA
1350001
India |
| Phone |
74000298409 |
| Fax |
|
| Email |
aviralsinghal119@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
J N Kapoor DAV Dental College, Yamunanagar |
| Address |
J N Kapoor DAV Dental College, Yamunanagar, Pincode 135001 |
| Type of Sponsor |
Other [Private Dental college] |
|
|
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 Aviral Singhal |
J N Kapoor DAV Dental College, Yamunanagar |
Department of Conservative Dentistry and Endodontics Room no 3
Yamunanagar
HARYANA |
7400298409
aviralsinghal119@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| J N Kapoor DAV Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AH Plus Root Canal Sealer |
Dentsply |
| Intervention |
Bio-root RCS root canal sealer |
Septodont |
| Comparator Agent |
Postoperative pain and Periapical extrusion in Bio-root RCS and AH plus root canal sealer |
Postoperative pain in Bio-root RCS (Septodont) and AH plus (Dentsply) root canal sealer at 24hours, 48 hours, 72 hours and 1 week and also periapical extrusion was checked |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients age 18yr to 50 yr.
2. Patients with asymptomatic apical periodontitis in mandibular premolars with
fully formed apex.
3. Healthy patients with ASAI and ASA II.
4. Patients who have not taken any analgesics for 72 hours before the treatment.
5. Patients who are willing to continue their treatment under study with written
informed consent.
6. Teeth with no anatomical variations.
7. Teeth with periapical radiolucency less than 3mm in size |
|
| ExclusionCriteria |
| Details |
1.Mandibular premolars with pus or inflammatory exudates draining through the
root canal or sinus tract.
2. Teeth with internal /external resorption.
3. Previously initiated root canal treatment.
4. Teeth with periodontal pockets of more than 3 mm during probing.
5. Teeth with mobility greater than grade one
6. Any pathology associated with tooth such as radicular cyst, periapical granuloma.
7. Teeth with vertical root fracture |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postopeative pain, Periapical extrusion and analgesics intake |
24hours, 48hours, 72 hours and 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="50"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
RESEARCH QUESTION Is there any difference in postoperative pain between bioceramic and resin-based root
canal sealer. Is there any difference in periapical extrusion seen between bioceramic and resinbased root canal sealer. Is there any association between pain and periapical extrusion between the two
sealers. AIM: The aim of this study will be to compare the postoperative pain and periapical
extrusion of sealer in asymptomatic apical periodontitis in mandibular premolar teeth
treated in two-visit using Bioceramic sealer and Resin based root canal sealer. OBJECTIVES: 1. To evaluate postoperative pain and periapical extrusion after using Bioceramic
sealer during two visit root canal treatment in asymptomatic apical periodontitis in
mandibular premolars. 2. To evaluate postoperative pain and periapical extrusion after using resin-based
root canal sealer during two visit root canal treatment in asymptomatic apical
periodontitis in mandibular premolars. 3. To compare the above-mentioned parameters. |