| CTRI Number |
CTRI/2023/01/049311 [Registered on: 31/01/2023] Trial Registered Prospectively |
| Last Modified On: |
20/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the presence of pain after single visit root canal treatment in lower back tooth region using newly introduced instruments |
|
Scientific Title of Study
|
Comparison Of Postoperative Pain In Single Visit Root Canal Treatment For Mandibular Molars With Symptomatic Irreversible Pulpitis Using Recently Introduced Heat Treated Nickel Titanium Rotary And Reciprocation Files |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poorani K |
| Designation |
Post Graduate Student |
| Affiliation |
CSI college of dental sciences and research |
| Address |
Roon No 6,CSI college of dental sciences and research,
Department of operative dentistry ad endodontics,129 CMH Compound,East veli street, Madurai
Madurai
TAMIL NADU
625001
India |
| Phone |
9994121072 |
| Fax |
|
| Email |
pooranikrishnamurthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of operative dentistry and endodontics |
| Affiliation |
CSI college of dental sciences and research |
| Address |
Roon No 6,CSI college of dental sciences and research,
Department of operative dentistry ad endodontics,129 CMH Compound,East veli street, Madurai
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of operative dentistry and endodontics |
| Affiliation |
CSI college of dental sciences and research |
| Address |
Roon No 6,CSI college of dental sciences and research,
Department of operative dentistry ad endodontics,129 CMH Compound,East veli street, Madurai
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
|
Source of Monetary or Material Support
|
| Poorani K, CSI College of dental sciences and research,Madurai,Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Poorani K |
| Address |
Room no 6,Deparrtment of operative dentistry and Endodontics,CSI college of dental sciences and research,129 CMH compound East Veli street,Madurai 625001 |
| 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 |
| Poorani K |
CSI College of Dental Sciences and Research Madurai |
Room no 6 Department
of Conservative
Dentistry and
Endodontics,129 CMH Compound, East Veli Street, Madurai,
Tamilnadu 625001
Madurai
TAMIL NADU |
9994121072
pooranikrishnamurthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee and Institutional Review Board |
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 |
| Intervention |
Device: root canal rotary files
|
Post operative pain evaluation using different rotary file system |
| Comparator Agent |
Rotary and reciprocation files |
Evaluation of post operative pain between rotary and reciprocation files |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Mandibular molar teeth with radiograph evidence of decay approximating the pulp with sound periodontal health. |
|
| ExclusionCriteria |
| Details |
1.Teeth not amenable to post-endodontic restoration
2.Teeth with periapical radiolucencies, presence of additional roots or canal variations
3. Absence of occlusal contacts
4. Teeth with difficult canal anatomy (curvatures > 30°, radiograph evidence of pulp chamber and canal calcification, open apices) and immunocompromised patients
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain evaluation using different rotary instruments |
48 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the post operative analgesics intake among participants |
48 hrs |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "220"
Final Enrollment numbers achieved (India)="220" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2023 |
| Date of Study Completion (India) |
10/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/11/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present clinical evaluation was planned for comparing the post-operative pain incidence in mandibular molar teeth with acute irreversible pulpitis treated by recently introduced heat treated nickel titanium rotary and reciprocation files in single-visit root canal treatment. |