| CTRI Number |
CTRI/2024/02/063064 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of pain following single visit root canal treatment using two different types of instruments. |
|
Scientific Title of Study
|
Comparative clinical evaluation of post endodontic pain following single visit root canal treatment with two different rotary file system –an in vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr sawan makwana |
| Designation |
doctor |
| Affiliation |
college of dental sciences and research center bopal |
| Address |
punjab vistar opp to main road hadmatiya gir ta talala gir dis gir somnath 362140
165/1 silver alaknanda society opp to dental college ghuma bopal ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
07698682298 |
| Fax |
|
| Email |
sawanmak12911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr sawan makwana |
| Designation |
doctor |
| Affiliation |
college of dental sciences and research center bopal |
| Address |
punjab vistar opp to main road hadmatiya gir ta talala gir dis gir somnath 362140
165/1 silver alaknanda society opp to dental college ghuma bopal ahmedabad
GUJARAT
380058
India |
| Phone |
07698682298 |
| Fax |
|
| Email |
sawanmak12911@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr sawan makwana |
| Designation |
doctor |
| Affiliation |
college of dental sciences and research center bopal |
| Address |
punjab vistar opp to main road hadmatiya gir ta talala gir dis gir somnath 362140
165/1 silver alaknanda society opp to dental college ghuma bopal ahmedabad
GUJARAT
380058
India |
| Phone |
07698682298 |
| Fax |
|
| Email |
sawanmak12911@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR SAWAN MAKWANA |
| Address |
punjab vistar opp to main road hadmatiya gir ta talala gir dis gir somnath 362140
165/1 silver alaknanda society opp to dental college ghuma bopal ahmedabad |
| 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 |
| Dr Sawan Makwana |
College of Dental Sciences and Research Centre, Manipur |
Room no 7, Department of Conservative Dentistry and Endodontics
Ahmadabad
GUJARAT |
7698682298
sawanmak12911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
who require the endodontic treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparison of post operative pain after single visit endodontic treatment |
comparison of two rotary file system with respect to post operative pain |
| Intervention |
single visit endodontic treatment |
root canal treatment performed on different teeth of same patient with different type of instruments. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Healthy male and female of 18 to 60 year
2 permanent upper and lower premolars and molar
3 teeth with asymptomatic irreversible pulpitis in ipsilateral or contralateral region (diagnosis was confirmed through history of chief complain, electric pulp test and radiographic examination)
4 periapical lesion either not present or if present, less than 2mm
|
|
| ExclusionCriteria |
| Details |
1 History of taking analgesic and antibiotic medication in past 12 hour
2 Pregnant female
3 Long standing non healed periapical lesion
4 Internal and external resorption
5 Deciduous tooth
6 Swelling
7 Teeth with Calcified canals
8 Teeth with Open apex
9 Fracture tooth
10 Complicated anatomical variation
11 presence of a periodontal pocket greater than 4 mm deep
12 greater than grade 1 mobility (according to miller’s classification)
13 moderate and severe bone loss
14 non restorable teeth
15 patients who are medically compromised or have known allergies of medicines
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| no significant difference observed in post endodontic pain using different rotary file system |
24 hr & 48 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| significant difference observed in post endodontic pain using different rotary file system |
72 hr & 7 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Topic : comparative clinical evaluation of post endodontic pain following single visit root canal treatment with two different rotary file system - an in vivo study material and methodology : 20 patient with two teeth indicated for endodontic treatment will be selected and treated with single visit therapy. individual teeth will be prepared with different rotary file systems. post operative pain will be measured using visual analogue scale on 1st 2nd 3rd and 7th day respectively after the treatment. data will be analyzed statistically |