| CTRI Number |
CTRI/2023/08/056102 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
03/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To assess the pain after root canal treatment using various rotary files system |
|
Scientific Title of Study
|
Comparative evaluation of postoperative pain in multi-visit root canal treatment using three different rotary files system- A randomized clinical 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 |
Swathi S |
| Designation |
PG Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of conservative dentistry and Endodontics, 2nd floor, clinic 21, 162 Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Department of conservative dentistry and Endodontics, 2nd floor, clinic 21, 162 Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
08807718000 |
| Fax |
|
| Email |
swathisureshkc18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandhya Raghu |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals, Department of conservative dentistry and Endodontics, 2nd floor, clinic 21, 162 Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Saveetha Dental College and Hospitals, Department of conservative dentistry and Endodontics, 2nd floor, clinic 21, 162 Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9884610410 |
| Fax |
|
| Email |
sandhya.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandhya Raghu |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals, Department of conservative dentistry and Endodontics, 2nd floor, clinic 21, 162 Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Saveetha Dental College and Hospitals, Department of conservative dentistry and Endodontics, 2nd floor, clinic 21, 162 Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9884610410 |
| Fax |
|
| Email |
sandhya.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals |
|
|
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 |
| Swathi S |
Saveetha dental college and hospitals |
Department of conservative dentistry and Endodontics, 2nd floor, clinic 21, 162 Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU |
8807718000
swathisureshkc18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College- Institutional Human ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patient undergoing root canal treatment |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Profit S3
|
Niti rotary file, rectangular cross section, variably variable taper design, used in root canal treatment for shaping and cleaning the canals in 20 minutes. |
| Comparator Agent |
Protaper gold, Protaper next
|
gold standard rotary files, used in root canal treatment for shaping and cleaning the canals in 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with irreversible pulpitis.
2. 18 years of age to 60
3. Maxillary and mandibular 1st and 2nd molar
4. Root canal curvature less than 20 degrees in Schneider’s technique
5. PAI score less than 2
|
|
| ExclusionCriteria |
| Details |
1. Patient with periapical cyst and abscess.
2. Pain scale value of more than 6
3. Presence of root caries or root fracture, sinus opening, swelling, Periodontally compromised teeth
4. Grade 2 or grade 3 mobility
5. Patients with systemic diseases and pregnant patients.
6. Patient has taken medication in the last 24 hrs.
7. Informed consent and not willing to participate in the study protocol.
|
|
|
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 |
To assess the post instrumentation pain by visual Analog Scale at 6hrs, 12hrs, 24hrs, 48hrs & 72 hours after instrumentation
|
visual Analog Scale at 6hrs, 12hrs, 24hrs, 48hrs & 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2023 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
Post-operative pain is defined as pain of any degree that occurs after initiation of root canal treatment
(RCT) (Sathorn et al. 2007). Although microorganisms are regarded as the primary cause of post
operative pain, inevitable extrusion of the irrigant solution, or debris that contain necrotic tissue,
microorganisms, pulpal fragments and dentine particles from the root canal space into the
periradicular tissues may also lead to post operative pain (Seltzer et al. 1985). There has been a paradigm shift from the use of stainless steel hand files to rotary NiTi files and more
recently to reciprocating NiTi instruments. The instruments along with the preparation techniques
have been considered as the principal contributing factor resulting in debris extrusion (Al-Omari et al.
1985, Fairbourn et al. 1987, Kustarci et al. 2008, Yeter et al. 2013). |