| CTRI Number |
CTRI/2021/12/038970 [Registered on: 28/12/2021] Trial Registered Prospectively |
| Last Modified On: |
03/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Compare and Evaluate Success rate of Kedo-S Square and Pro AF Baby Gold Rotary File System in Primary Teeth |
|
Scientific Title of Study
|
Comparative Evaluation Of Clinical And Radiographic Outcome Between Kedo-S Square Rotary System And Pro AF Baby Gold Rotary System In Primary Molars: A Randomized Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sindhu Shree G S |
| Designation |
Post Graduate |
| Affiliation |
Bapuji Dental College And Hospital |
| Address |
Room Number 3,Department Of Pedodontics And Preventive Dentistry,Bapuji Dental College And Hospital
Davanagere
KARNATAKA
577004
India |
| Phone |
9945650944 |
| Fax |
|
| Email |
sindhushreegs13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basappa N |
| Designation |
Professor And Head of the Department |
| Affiliation |
Bapuji Dental College And Hospital |
| Address |
Room Number 3, Department Of Pedodontics And Preventive Dentistry, Bapuji Dental College And Hospital
Davanagere
KARNATAKA
577004
India |
| Phone |
9449730322 |
| Fax |
|
| Email |
basappa.nadig64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basappa N |
| Designation |
Professor And Head of the Department |
| Affiliation |
Bapuji Dental College And Hospital |
| Address |
Room Number 3,Department Of Pedodontics And Preventive Dentistry,Bapuji Dental College And Hospital
Davanagere
KARNATAKA
577004
India |
| Phone |
9449730322 |
| Fax |
|
| Email |
basappa.nadig64@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bapuji Dental College And Hospital,MCC B Block,Davanagere-577004 |
|
|
Primary Sponsor
|
| Name |
Dr Sindhu Shree G S |
| Address |
Room Number 3,Department Of Pedodontics And Preventive Dentistry,Bapuji Dental College And Hospital |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR BASAPPA N |
ROOM NO 3 BAPUJI DENTAL COLLEGE AND HOSPITAL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sindhu Shree G S |
Bapuji Dental College And Hospital |
Room Number 3, Department Of Pedodontics And Preventive Dentistry,MCC B Block,Davanagere-577004
Davanagere
KARNATAKA |
9945650944
sindhushreegs13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Review Board ,Bapuji Dental College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kedo-S Square Rotary File System |
Single File System,NiTi heat treated,Titanium Oxide Coated,Dual Cross Section file
P1 File Of standard size 16 mm
used at speed of 250-300 rpm
Torque 2.2-2.4 N.cm |
| Comparator Agent |
Pro AF Baby Gold Rotary File System |
Two File System,Short 17 mm file ,Advanced NiTi CM wire for better canal centricity,used in combination of 4% and 6% taper,20,25,30 and 40 number files available |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Frankel’s behaviour rating: Definitely positive and Positive child.
Primary molar teeth with atleast 2/3 rd root length remaining.
Children in age group 5-8 years with primary molars with nonvital pulps or irreversible pulpitis.
|
|
| ExclusionCriteria |
| Details |
Patients with any systemic illness.
Teeth with pathological external or internal root resorption.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The instrumentation time, extent of obturation, pain perception, clinical and radiographic outcome between Kedo-S Square rotary system and Pro AF Baby Gold rotary system in primary molars. |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2022 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS RANDOMIZED ,DOUBLE BLIND,PARALLEL GROUP CLINICAL TRIAL,COMPARING AND EVALUATING CLINICAL AND RADIOGRAPHIC OUTCOME BETWEEN KEDO -S SQUARE ROTARY SYSTEM AND PRO AF BABY GOLD ROATRY SYSTEM IN PRIMARY MOLARS FOR 6 MONTHS REQUIRING PULPECTOMY IN 40 PATIENTS. THE PRIMARY OUTCOME MEASURES WILL BE INSTRUMENTATION TIME DURING PROCEDURE,EXTENT OF OBTURATION AFTER PROCEDURE, PAIN PERCEPTION DURING AND 1 WEEK AFTER PROCEDURE USING UNIVERSAL PAIN ASSESSMENT TOOL AND CLINICAL AND RADIOGRAPHIC SUCCESS RATE DURING FOLLOWUP PERIOD OF 3 MONTHS AND 6 MONTHS.
|