| CTRI Number |
CTRI/2024/09/073627 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical comparison of quality of root canal filling material and post-procedural pain in primary teeth using 2 different rotary files |
|
Scientific Title of Study
|
Clinical comparison of quality of obturation and postoperative pain in primary molars using Kedo-SG and Kedo-plus Square files (A Pilot 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 |
Dr Balagopal Varma |
| Designation |
HOD, Principal of Amrita School of Dentistry |
| Affiliation |
Amrita School of Denistry |
| Address |
R.No - 5, 1st floor, Amrita school of dentistry, Ponekkara, Kochi
R.No - 5, 1st floor, Amrita school of dentistry, Ponekkara, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9447032358 |
| Fax |
|
| Email |
balagopalvarma@aims.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balagopal Varma |
| Designation |
HOD, Principal of Amrita School of Dentistry |
| Affiliation |
Amrita School of Denistry |
| Address |
R.No - 5, 1st floor, Amrita school of dentistry, Ponekkara, Kochi
R.No - 5, 1st floor, Amrita school of dentistry, Ponekkara, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9447032358 |
| Fax |
|
| Email |
balagopalvarma@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balagopal Varma |
| Designation |
HOD, Principal of Amrita School of Dentistry |
| Affiliation |
Amrita School of Denistry |
| Address |
R.No - 5, 1st floor, Amrita school of dentistry, Ponekkara, Kochi
R.No - 5, 1st floor, Amrita school of dentistry, Ponekkara, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9447032358 |
| Fax |
|
| Email |
balagopalvarma@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita School of Dentistry
AIMS, Ponekkara
Kochi - 682041
India |
|
|
Primary Sponsor
|
| Name |
Amrita School of Dentistry |
| Address |
R.No-5, 1st floor
Amrita School of Dentistry
Ponekkara, Kochi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 A Rohitha Sravya |
Amrita School of Dentistry |
R.No - 5, 1st floor, Amrita school of dentistry, Ponekkara, Kochi
Ernakulam
KERALA |
09381697497
rohitha.sravya07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Vishwa Vidyapeetham Institute of Medical Sciences Healthcare, Education & Research Institutional Ethics Committee |
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 |
Kedo SG files |
3 hrs., 6 hrs., 12 hrs., 24 hrs., 48 hrs. |
| Intervention |
Kedo-S Plus files |
3 hrs., 6 hrs., 12 hrs., 24 hrs., 48 hrs. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Amount of tooth structure sufficient for placing a rubber dam clamp
Presence of at least two-third of the root length
Primary molar teeth with chronic irreversible pulpitis
|
|
| ExclusionCriteria |
| Details |
Patients with systemic disease
Excessive mobility
More than one-third of root resorption
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the quality of root canal filling in primary molars using Kedo-SG and Kedo-S plus files |
After 1 hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of post-operative pain in primary molars using Kedo-SG and Kedo-S Plus files |
Post-operative pain is measured at 5 different timepoints - 3 hrs., 6 hrs., 12 hrs., 24 hrs., 48 hrs. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
19/09/2024 |
| 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="3"
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 - 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Data will be available at our institution
- For how long will this data be available start date provided 29-10-2024 and end date provided 28-12-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title of study: Clinical comparison of quality of obturation and post-operative pain in primary molars using Kedo-SG and Kedo-S plus files Synopsis of Study 1. Study Design: A Clinical trial 2. Rationale of the study: To evaluate the quality of obturation and postoperative pain in primary molars using Kedo-SG and Kedo-S plus files 3. Deficiency in literature prompting this study: No clinical comparison of quality of obturation and post-operative pain was done using Kedo-SG and Kedo-S plus files (rotary files) in primary molars 4. Methodology: After access opening & working length determination, root canal shaping is done through Kedo-SG files(Group I) and Kedo- S plus files(Group II). Then, BMP & Obturation will be done; the quality of obturation will be assessed by IOPAR followed by post-endo restoration. The post-operative pain is assessed through Faces pain scale after 3 hrs, 6 hrs, 12 hrs, 24 hrs, 48 hrs. Mann-Whitney U test for skewed data will be used to test the statistical significance. 5. References – Comparative evaluation of the quality Of Obturation, Instrumentation Time And Post Operative Pain After Pulpectomy In Primary Molars Using Hand-K Files, Kedo-S Square And Kedo-S Plus Rotary Files Dinesh Kumar, Ganesh Jeevanandan; Int J of Med Dent, Vol 27 Issue 3 July / Sept 2023 Incidence of Post-Operative Pain following a Single-Visit Pulpectomy in Primary Molars Employing Adaptive, Rotary, and Manual Instrumentation: A Randomized Clinical Trial Bhagyashree Thakur, 2023 |