| CTRI Number |
CTRI/2023/10/058532 [Registered on: 11/10/2023] Trial Registered Prospectively |
| Last Modified On: |
25/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of two different motion kinematics on post operative pain. |
|
Scientific Title of Study
|
Comparative evaluation of postoperative pain after single visit root canal treatment using rotary and reciprocating file systems with and without glide path preparation: A randomised clinical trial. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fatima Siddiqui |
| Designation |
Junior resident |
| Affiliation |
Dr. Ziauddin Ahmad Dental College |
| Address |
Department of conservative dentistry and endodontics, OPD 7, Dr. Ziauddin Ahmad Dental College, Medical road AMU campus
Aligarh
Department of conservative dentistry and endodontics, OPD 7 Dr. Ziauddin Ahmad Dental College, Medical road AMU campus, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9956543906 |
| Fax |
|
| Email |
fatimasiddiqui246@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sajid Ali |
| Designation |
Assistant Professor |
| Affiliation |
Dr. Ziauddin Ahmad Dental College |
| Address |
Department of conservative dentistry and endodontics , OPD 7, Dr. Ziauddin Ahmad Dental College, Medical road,AMU campus
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9410693834 |
| Fax |
|
| Email |
sajid.bds.amu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Fatima Siddiqui |
| Designation |
Junior resident |
| Affiliation |
Dr. Ziauddin Ahmad Dental College |
| Address |
Department of conservative dentistry and endodontics , OPD 7, Dr. Ziauddin Ahmad Dental College, Medical road AMU campus
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9956543906 |
| Fax |
|
| Email |
fatimasiddiqui246@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Z.A dental College, Medical road, AMU, Aligarh- 202002 |
|
|
Primary Sponsor
|
| Name |
Fatima Siddiqui |
| Address |
Dr Ziauddin Ahmad Dental College, Medical road AMU campus, Aligarh-202002 |
| 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 |
| Fatima Siddiqui |
Dr Ziauddin Ahmad dental college |
Department of conservative dentistry and endodontics, OPD 7 Medical Road, Aligarh
Aligarh
UTTAR PRADESH |
09956543906
fatimasiddiqui246@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,JNMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
reciprocating file |
cleaning and shaping of the root canal system using the instrument with reciprocating motion during single visit treatment. |
| Comparator Agent |
rotary file |
cleaning and shaping of the root canal system using the instrument with rotation motion during single visit treatment. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients with asymptomatic non-vital mandibular first molars indicated for conventional endodontic treatment.
|
|
| ExclusionCriteria |
| Details |
patients with teeth with symptomatic apical periodontitis,
Pregnant females,
Patients with any uncontrolled systemic disease
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.post operative pain |
6hours,12hours,24hours,48hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.post operative pain |
3 days, 4 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "128"
Final Enrollment numbers achieved (India)="128" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/10/2023 |
| Date of Study Completion (India) |
31/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="3" |
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
|
Several etiologic factors are attributed to this postoperative pain
such as history of preoperative pain, insufficient root canal debridement,
hyper occlusion, periapical disease, and extrusion of infected debris into the
periapical tissue. It has been found that out of all the factors, debris
extrusion is found to be highly associated with pain. Keeping the above in mind
newer thermomechanically treated NiTi instruments are being developed and put
to use. This study aims to study the difference in post-operative pain using two
new file systems with different motion kinematics.
|