| CTRI Number |
CTRI/2022/01/039770 [Registered on: 27/01/2022] Trial Registered Prospectively |
| Last Modified On: |
25/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Post-operative pain on using different root canal filling techniques |
|
Scientific Title of Study
|
Evaluation of post-obturation pain after using different obturation techniques in patients undergoing root canal treatment - a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavalipurapu Venkata Teja |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic-21
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600007
India |
| Phone |
9751933999 |
| Fax |
|
| Email |
venkatatejak.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavalipurapu Venkata Teja |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic-21
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600007
India |
| Phone |
9751933999 |
| Fax |
|
| Email |
venkatatejak.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavalipurapu Venkata Teja |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic-21
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600007
India |
| Phone |
9751933999 |
| Fax |
|
| Email |
venkatatejak.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospital |
| Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
| 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 |
| Kavalipurapu Venkata Teja |
Saveetha Dental College and Hospital |
Department of Conservative Dentistry and Endodontics, Clinic-21
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU |
9751933999
venkatatejak.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College and Hospitals Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic Irreversible Pulpitis with apical periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cold Lateral Compaction |
Root canal obturated with cold lateral compaction technique
Duration of therapy per root canal: 2 visits (2 hours each) |
| Intervention |
Single Cone Obturation,
Thermoplastic Obturation |
Root canal obturated with single cone obturation and thermoplastic obturation
Duration of therapy per root canal: 2 visits (2 hours each) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
mandibular molars diagnosed as asymptomatic
irreversible pulpitis with apical periodontitis |
|
| ExclusionCriteria |
| Details |
medically compromised patients,
pregnant women, patients on antibiotic therapy, teeth with incomplete apex formation, teeth with calcified canals,
teeth with periapical abscess, and sinus opening |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post-operative pain measurement using Heft Parker Scale |
8 hours, 12 hours, 24 hours, 48 hours, 72 hours and 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/01/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
One of the important aspects of root canal therapy is to control pain after treatment. Postoperative pain is an unwanted yet unfortunately common sensation after endodontic treatment. The incidence of postoperative pain was reported to range from 3% to 58%.There is no single factor affecting pain after root canal treatment and it may be due to mechanical, chemical and/or microbial injury to the pulp or periradicular tissues. Mechanical factors, including over instrumentation or extrusion of root-filling materials, have been associated to the presence of postoperative pain. |