| CTRI Number |
CTRI/2024/02/062368 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of Caries Removal Efficacy using Gentle Hand instrument and Spoon Excavator In Primary Molars. |
|
Scientific Title of Study
|
Comparative Evaluation of Caries Excavation Efficacy of Gentle Hand Bur Systems and Spoon Excavator in Primary Molars: Randomized Control 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 |
Anuja Gaikwad |
| Designation |
Post Graduate Student |
| Affiliation |
K M Shah Dental College and Hospital,Waghodia |
| Address |
Room No.3,Department of Pediatric and Preventive Dentistry,1st floor,K M Shah Dental College and Hospital,Waghodia 391760,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9403465374 |
| Fax |
|
| Email |
gaikwadanuja46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Poonacha K.S. |
| Designation |
Professor and PG Guide |
| Affiliation |
K M Shah Dental College and Hospital,Waghodia |
| Address |
Room No.3 Department of Pediatric and Preventive Dentistry,1st floor,K M Shah Dental College and Hospital,Waghodia 391760,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9725036673 |
| Fax |
|
| Email |
poochi2263@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuja Gaikwad |
| Designation |
Post Graduate Student |
| Affiliation |
K M Shah Dental College and Hospital,Waghodia |
| Address |
Room No.3 Department of Pediatric and Preventive Dentistry, 1st floor, K M Shah Dental College and Hospital,Waghodia 391760,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9403465374 |
| Fax |
|
| Email |
gaikwadanuja46@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.M.Shah Dental College and Hospital,Sumandeep Vidyapeeth,Waghodia-391760,Vadodara |
|
|
Primary Sponsor
|
| Name |
Anuja Gaikwad |
| Address |
K M Shah Dental College and Hospital,Waghodia |
| Type of Sponsor |
Other [Personal] |
|
|
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 Anuja Gaikwad |
K.M.Shah Dental College and Hospital Waghodia-391760 |
Room Number-3,Department of Pediatric and Preventive Dentistry,1st floor
Vadodara
GUJARAT |
9403465374
gaikwadanuja46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children with dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gentle Hand Bur Systems |
It contains four handles and used for the initial caries removal.The study will be conducted for 1 year |
| Comparator Agent |
Spoon Excavator |
EXC18, Hu-Friedy Mfg.Co. Rockwell St. Chicago, USA.
EXC 19, Hu-Friedy Mfg.Co. Rockwell St. Chicago, USA.The study will be conducted for duration of 1 year. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Occlusal carious lesions in maxillary or mandibular primary 1st and 2nd molars
2.Caries 1.2 according to Mount and Humes classification
3.Children whose parents give consent for study
4.Frankel behaviour rating scale 3 and 4 |
|
| ExclusionCriteria |
| Details |
1.Molars with one of the following signs and symptoms periodontal,pulpal pathology
2.Non vital teeth
3.Children with congenital abnormalities or systemic diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gentle Hand bur systems will likely reduce the discomfort of patient during caries removal |
The caries removal efficacy and pain will be assessed on the 1st day only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gentle hand bur systems will likely reduce the pain during caries excavation process |
Modified Wong Bakers scale will be used to asses the pain & caries removal efficacy using caries dye will be assessed on 1st day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
08/03/2024 |
| Date of Study Completion (India) |
25/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Gradual evolution of caries excavation techniques have changed the concept of cavity preparation. Caries excavation with the use of conventional technique is associated with discomfort and pain to the patients so the new hand systems has been introduced named Gentle Hand Bur Systems which claims to reduce the pain associated with the caries removal so this study aims to check the caries removal efficacy and pain reduction during caries excavation with the new system |