| CTRI Number |
CTRI/2014/08/004935 [Registered on: 27/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
26/08/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of two different dental burs in dentin caries removal |
|
Scientific Title of Study
|
comparative evaluation of two novel mechano-rotary instrumentation techniques in selective dentin caries removal:an invivo study |
| Trial Acronym |
BURS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AMEET J KURTHUKOTI |
| Designation |
PROFESSOR |
| Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
| Address |
PROFESSOR
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
COORG INSTITUTE OF DENTAL SCIENCES VIRAJPET
COORG KARNATAKA
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
COORG INSTITUTE OF DENTAL SCIENCES VIRAJPET
COORG KARNATAKA
Kodagu
KARNATAKA
571218
India |
| Phone |
9886779586 |
| Fax |
08274-260652 |
| Email |
ameet_k@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AMEET J KURTHUKOTI |
| Designation |
PROFESSOR |
| Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
| Address |
PROFESSOR
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
COORG INSTITUTE OF DENTAL SCIENCES VIRAJPET
COORG KARNATAKA
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
COORG INSTITUTE OF DENTAL SCIENCES VIRAJPET
COORG KARNATAKA
Kodagu
KARNATAKA
571218
India |
| Phone |
9886779586 |
| Fax |
08274-260652 |
| Email |
ameet_k@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DRLIBINA ISAHAK |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
COORG INSTITUTE OF DENTAL SCIENCES VIRAJPET
COORG KARNATAKA
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
COORG INSTITUTE OF DENTAL SCIENCES VIRAJPET
COORG KARNATAKA
Kodagu
KARNATAKA
571218
India |
| Phone |
9480022858 |
| Fax |
08274-260652 |
| Email |
libinaisahak0@gmail.com |
|
|
Source of Monetary or Material Support
|
| COORG INSTITUTE OF DENTAL SCIENCES,VIRAJPET |
|
|
Primary Sponsor
|
| Name |
DR AMEET J KURTHUKOTI |
| Address |
no:1643
6th Main road
Hebbard 2nd stage
Mysore 5700017 |
| Type of Sponsor |
Other [PRIVATE 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 AMEET J KURTHUKOTI |
DEPARTMENT OF PEDODONTICS&PREVENTIVE DENTISTRY |
COORG INSTITUE OF DENTAL SCIENCES ,VIRAJPET,COORG
KARNATAKA,571218
Kodagu
KARNATAKA |
9886779586
08274-260652
ameet_k@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
children with dentinal caries involvement of permanent 1st molar, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ceramic bur and polymer bur |
Newly introduced two burs in dentistry for dentin caries excavation. commercially available as CeraBur and smart prep bur.made up of ceramics and Polyamide polymer |
| Comparator Agent |
conventional steel bur |
commonly using bur for caries excavation in dentistry.made up of stainless steel |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
children in age group of 8 to 14 years irrespective of race,sex and socioeconomic status having at-least 3 occlusal carious lesions on any of the maxillary /mandibular 1st permanent molars in any of the quadrants of the dental arch with dentinal involvement as evidenced by digital radio graphs and with an opening occlusal diameter of at-least 2 mm.
1st permanent molar teeth which display a positive response to sensibility testing using heat,cold and mechanical stimulation
|
|
| ExclusionCriteria |
| Details |
subjects with rampant caries.
subjects who are uncooperative,physically,mentally challenged
1st permanent molar teeth with buccal,palatal,proximal,cervical carious lesions
1st permanent molar teeth that do not respond to any form of sensibility testing
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessing the completeness of caries removal immediately after treatment.
patient satisfaction during treatment with the help of questionaire |
Assessing the completeness of caries removal immediately after treatment.
patient satisfaction during treatment with the help of questionaire |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| presence of secondary caries and success of restoration |
after 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized cross over study split mouth design to evaluate and compare the efficacy of selective carious dentin removal using conventional steel bur,polymer bur and ceramic bur in 40 patients visiting the out-patient Department of Pedodontics and Preventive Dentistry,Coorg Institue of Dental Sciences,Virajpet. The primary outcome will be clinical effectiveness of caries removal,time taken for caries removal and patient comfort during treatment .The secondary out come will be success of restoration clinically and presence of secondary caries after 6 months |