| CTRI Number |
CTRI/2025/05/086426 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| 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 Using Two Different Sealers and Canal Tapers |
|
Scientific Title of Study
|
Comparison of Postoperative Pain in Single-Rooted Teeth With Asymptomatic Apical Periodontitis Using Two Bioceramic Sealers and Two Different Root Canal Tapers: A Single-Blind Randomized Controlled 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 Poornima Wazarkar |
| Designation |
PG Student |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai
Thane MAHARASHTRA 400614 India |
| Phone |
7020408705 |
| Fax |
|
| Email |
wazarkar.poornima@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rahul Rao |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai
Thane MAHARASHTRA 400614 India |
| Phone |
9820094178 |
| Fax |
|
| Email |
drrahulrao25@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Poornima Wazarkar |
| Designation |
PG Student |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai
Thane MAHARASHTRA 400614 India |
| Phone |
7020408705 |
| Fax |
|
| Email |
wazarkar.poornima@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Poornima Wazarkar
Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai, Maharahtra, India 400614
|
|
|
Primary Sponsor
|
| Name |
Dr Poornima Wazarkar |
| Address |
Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614 |
| 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 |
| Dr Poornima Wazarkar |
Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai |
Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614 Thane MAHARASHTRA |
7020408705
wazarkar.poornima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BIO-C (Angelus) sealer |
BIO-C (Angelus) sealer will be used to obturate the root canal with 4% and 6% tapers named as subgroup A1 and subgroup A2 respectively. Post-operative pain will be checked at 6, 12, 24, 48 and 72 hours.
GROUP A [CONTROL]: BIO-C (Angelus) sealer
Subgroup A1: 4% Taper
Subgroup A2: 6% Taper |
| Intervention |
BioActive RCS (SafeEndo) sealer |
BioActive RCS (SafeEndo) sealer will be used to obturate the root canal with 4% and 6% tapers named as subgroup B1 and subgroup B2 respectively. Post-operative pain will be checked at 6, 12, 24, 48 and 72 hours.
GROUP B [EXPERIMENTAL]: BioActive RCS (SafeEndo) sealer
Subgroup B1: 4% Taper
Subgroup B2: 6% Taper |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cooperative healthy patients who are willing to participate in the study and sign consent form.
Age: 18-60 years
Teeth: single rooted teeth with asymptomatic apical periodontitis indicated for RCT.
Radiographic changes limited to slight widening of PDL space and loss of lamina dura.
|
|
| ExclusionCriteria |
| Details |
Pregnant, medically compromised and patients with uncontrolled diabetes are excluded from the study.
Patient unable to give informed consent.
Patient taken any medication like analgesic, antibiotics, 24 hours before treatment visit |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain scores |
Post operative pain scores at 6 hours, 12 hours, 24 hours, 48 hours and 72 hours between the group A and group B |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pain scores |
Post operative pain scores at 6 hours, 12 hours, 24 hours, 48 hours & 72 hours between subgroups A1, A2, B1 & B2 |
|
|
Target Sample Size
|
Total Sample Size="112" Sample Size from India="112"
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)
|
20/05/2025 |
| 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="6" Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [wazarkar.poornima@gmail.com].
- For how long will this data be available start date provided 03-02-2026 and end date provided 03-02-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Postoperative pain is the most common occurrence after endodontic treatment. It occurs mainly due to mechanical, chemical or microbial injury to periapical tissues. Root canal sealers plays a crucial role in this regard by coming in contact with periapical tissues through apical foramen and lateral canals causing a localised inflammation with direct influence on degree of post-operative pain based on composition of sealers. In this regard, bioceramic sealers offer a major advantage of biocompatibility and ability to form a hermetic seal. Furthermore, bioceramic sealers enhance endodontic treatment outcomes by differentiation of odontoblasts and release of bioactive substances which aid in periapical healing. Many authors have reported apical preparations to sizes larger than recommended to completely disinfect the root canal. On the contrary, it is often argued that larger preparation size results in unnecessary removal of dentin leading to weakening of tooth structure. Recently, new injectable Bioceramic sealers have been developed possessing better properties like uniform consistency and flow which allow them to penetrate into irregularities and accessory canals of root canal system, ultimately improving the quality of obturation and endodontic outcome. No literature was found which compared the effect of root canal tapers on postoperative pain using BioActive RCS root canal sealer which is relatively new Bioceramic sealer. Hence this study is designed. |