| CTRI Number |
CTRI/2023/08/057008 [Registered on: 28/08/2023] Trial Registered Prospectively |
| Last Modified On: |
14/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of cleaning of root canals on result of Root Canal Treatment |
|
Scientific Title of Study
|
Influence of apical third enlargement to different sizes and Tapers on endodontic treatment outcome: An In Vivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayatri Khode |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Ahmedabad |
| Address |
Department of conservative dentistry and endodontics, govt dental
college and hospital, civil hospital campus,
asarwa,ahmedabad.380016
Ahmadabad
GUJARAT
India
512, C-block, Dental pg girls hostel, Govt Dental College and hospital, Civil Hospital Campus, asarwa, Ahmedabad, 380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
9545882253 |
| Fax |
|
| Email |
gayatri.khode4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Kanodia |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital Ahmedabad |
| Address |
Department of conservative dentistry and endodontics, govt dental
college and hospital, civil hospital campus,
asarwa,ahmedabad.380016
Ahmadabad
GUJARAT
India
Kamalkumar,9,Sahajanand Villa-1, new CG road ,Chandkheda, Gandhinagar, Gandhinagar, Gujarat 382424
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825465861 |
| Fax |
|
| Email |
Shikhakk@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Khode |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Ahmedabad |
| Address |
Department of conservative dentistry and endodontics, govt dental
college and hospital, civil hospital campus,
asarwa,ahmedabad.
Ahmadabad
GUJARAT
India
512, C-block, Dental pg girls hostel, Govt Dental College and hospital, Civil Hospital Campus, asarwa, Ahmedabad, 380016
Gandhinagar
GUJARAT
380016
India |
| Phone |
9825465861 |
| Fax |
|
| Email |
gayatri.khode4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics, Government Dental College and Hospital, Gujarat, 380016 |
|
|
Primary Sponsor
|
| Name |
Government Dental College and hospital Ahmedabad |
| Address |
Govt. dental
college and hospital, civil hospital campus,
asarwa,ahmedabad.380016
Ahmadabad
GUJARAT
330016
India |
| Type of Sponsor |
Other [Government Dental College] |
|
|
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 Gayatri Khode |
Government dental college and Hospital Ahmedabad |
Room no 9, Dept of Conservative Dentistry and endodontics, Govt Dental College and Hospital, Civil Hospital Campus, Ahmedabad, 380016
Ahmadabad
GUJARAT |
9545882253
gayatri.khode4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Different file sizes(apical preparation to different sizes and tapers) will be used in the study |
Post operative evaluation of healing of periapical lesion will be done after root canal preparation to different sizes and tapers.
Groups of the study are as follows-
1)2 Sizes LARGER than IABF with constant taper
2)3 Sizes LARGER than IABF with constant taper
3)2 Sizes LARGER than IABF with variable taper
4)3 Sizes LARGER than IABF with variable taper
|
| Intervention |
Root Canal treatment |
Root Canal Treatment will be done according to different file sizes(comparing different sizes and taper of preparation) |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Healthy, american association of anaesthetologists (ASA)-1 patients
2)Patients of either sex
3)Asymtomatic apical periodontitis in maxillary/ mandibular 1st/2nd molars with radiographic evidence of peri-apcal radiolucency
4)Corresponding to Periapical Index score ≥ 3
|
|
| ExclusionCriteria |
| Details |
1)Patients who were medically compromised
2)Pregnant
3)Uncontrolled Diabetes Mellitus
4)Patients with history of analgesic intake in past one week |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Postoperative pain should not be influenced by the apical preparation Taper & Size of the
instrument.
2.Preparation of the apical third to variable taper will have favorable effect on outcome of primary
endodontic treatment.
3. Apical preparation to 2 sizes larger than the IABF is insufficient & results in a lower success rate
compared with preparations done with larger sizes. |
The outcome will be assessed after 1 month, 6
months & 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Apical preparation to 2 sizes larger than the IABF is insufficient & results in a lower success rate
compared with preparations done with larger sizes. |
The outcome will be assessed after 1 month, 6
months & 12 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Influence of apical third enlargement to different sizes and tapers on endodontic treatment outcome: an in vivo study
Aim: To evaluate the effect of apical third enlargement to different sizes and tapers on outcome of endodontic treatment. Objective: To evaluate pain and healing after preparing apical third of the canals to different sizes and tapers. Evaluation criteria: 1)Post-operative pain evaluation using vas scale 2)Periapical radiolucency comparison using the Periapical Index (PAI) score
|