| CTRI Number |
CTRI/2016/10/007332 [Registered on: 04/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
30/09/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF EFFICACY AND ACCEPTABILITY OF CARIES REMOVAL METHODS - A RANDOMIZED CONTROLLED CLINICAL TRIAL |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY AND ACCEPTABILITY OF CARIES REMOVAL METHODS : CARIE CARE WITH ATRAUMATIC RESTORATIVE TREATMENT AND CONVENTIONAL METHOD - A RANDOMIZED CONTROLLED 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 |
malavika j |
| Designation |
post graduate student |
| Affiliation |
the oxford dental college and hospital |
| Address |
the oxford dental college and hospital
10th Milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka 560068
the oxford dental college and hospital
10th Milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA
560104
India |
| Phone |
9591113330 |
| Fax |
|
| Email |
jmalavika91@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SS Hiremath |
| Designation |
professor and head of the public health dentistry department |
| Affiliation |
the oxford dental college and hospital |
| Address |
the oxford dental college and hospital
10th Milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka
the oxford dental college and hospital
10th Milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9448466913 |
| Fax |
|
| Email |
hiremath29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SS Hiremath |
| Designation |
professor and head of the public health dentistry department |
| Affiliation |
the oxford dental college and hospital |
| Address |
the oxford dental college and hospital
10th Milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka
the oxford dental college and hospital
10th Milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka 560068
KARNATAKA
560068
India |
| Phone |
9448466913 |
| Fax |
|
| Email |
hiremath29@gmail.com |
|
|
Source of Monetary or Material Support
|
| malavika.j
#168,1st c cross,6th A main,remco layout,Vijayanagar,Bangalore-560104 |
|
|
Primary Sponsor
|
| Name |
MalavikaJ |
| Address |
The Oxford dental college and hospital,10th milestone, hosur road, Bommanahalli, Bengaluru, Karnataka 560068 |
| 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 |
| malavika |
the oxford dental college |
the oxford dental college and hospital
10th Milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA |
9591113330
jmalavika91@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutinal ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
dental caries , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
atraumatic restorative treatment,conventional method |
used in dental caries removal, where only hand instruments are used and airotor is used in conventional method |
| Intervention |
carie care |
used in dental caries removal.it is a chemomechanical agent which softens the dentine and the excavation is done later easily using hand instruments |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
• School going children who are in the age group of 5-9 years and who are willing to participate in the study, with consent form signed by parents.
• Patients with one or more open occlusal carious lesions of primary teeth on different quadrants
|
|
| ExclusionCriteria |
| Details |
• School children who are not co-operative and not willing to participate in the study.
• Teeth with deep carious lesions involving pulp
• Teeth with proximal carious lesions
• Teeth with clinical signs and symptoms of pulpal and periapical lesions
• Children with presence of any systemic illness
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| acceptability and efficacy of caries removal methods |
immediately |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain and time taken, |
immediately |
|
|
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 4 |
|
Date of First Enrollment (India)
|
21/12/2015 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
objectives: to evaluate and compare the efficacy of caries removal,time taken,pain experienced and patient acceptance of chemomechanical caries removal method with that of atraumatic restorative treatment and conventional method. materials and methods:this will be a randomized controlled clinical trial, study will be conducted in the department of public health dentistry the oxford dental college,the oxford medical college,puttenahalli peripheral centre bangalore. this study sample consists of 75 children 5-9 years old selected from schools or opd.all children who met inclusion and exclusion criteria are selected.a total of 120 carious teeth is selected and divided into three groups for the ART, conventional method and chemomechanical caries removal methods. the efficacy of caries removal methods is assessed by visual inspection and tactile sensation.the time taken for caries removal methods is noted from the start of the procedure till the end using stop watch.pain threshold is evaluated using visual analog scale, acceptability of the three methods is assessed by the following questions,how did you experience the treatment,how did you find the taste,how did you find the smell.the efficacy of caries removal methods is analysed by chi square test,the pain threshold and time taken using anova followed by post hoc analysis and acceptability by using chi- square test. |