| CTRI Number |
CTRI/2024/01/061258 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Dental Anxiety in different methods of Tooth decay treatments |
|
Scientific Title of Study
|
Dental Anxiety Associated With Chemo-Mechanical Caries Removal Method, Conventional Method And Atraumatic Restorative Treatment: A Randomized Controlled Trial |
| 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 Anakapalli Sai Praharsh |
| Designation |
Post Graduate Student |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Room No. 5, Department of Public Health Dentistry, Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530003
India |
| Phone |
7093790270 |
| Fax |
|
| Email |
aspraharsh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Vamsi Krishna Reddy |
| Designation |
Professor and Head of Departmet |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Room No. 5, Department of Public Health Dentistry, Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530003
India |
| Phone |
9908200033 |
| Fax |
|
| Email |
principal.anids@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anakapalli Sai Praharsh |
| Designation |
Post Graduate Student |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Room No. 5, Department of Public Health Dentistry, Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530003
India |
| Phone |
7093790270 |
| Fax |
|
| Email |
aspraharsh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil Neerukonda Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Anakapalli Sai Praharsh |
| Address |
Room No. 5, Department of Public Health Dentistry, Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Visakhapatnam |
| 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 |
| Dr Anakapalli Sai Praharsh |
Anil Neerukonda Institute of Dental Sciences |
Room No. 5, Department of Public Health Dentistry, Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH |
7093790270
aspraharsh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Anil Neerukonda Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atraumatic Restorative Treatment (ART) |
Caries removal by Atraumatic Restorative Treatment (ART)
Duration: 15 mins |
| Intervention |
Chemo mechanical caries removal agent |
Caries removal with chemomechanical caries temoval agent V-Carie Solve (Vishal Dentocare Ltd.)
Duration: 15 minutes |
| Comparator Agent |
Conventional treatment methods |
Caries removal by Conventional (Airotor and Burs) treatment methods
Duration: 15 minutes |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children of 6 - 14 yrs of age who are willing to participate and with signed consent form by parents
Teeth with a broad occlusal cavitated lesion showing brown and softened dentin clinically and radiographically |
|
| ExclusionCriteria |
| Details |
Teeth with pulpal exposures
Teeth with spontaneous pain, mobility, swelling, and fistulae
Teeth with furcation involvement, cervical lesions, Teeth with restorations, sealants, or enamel defects |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dental anxiety recorded using Facial Image Scale score before treatment |
before treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dental anxiety recorded using Facial Image Scale score after treatment |
after treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/01/2024 |
| 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="0"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Throughout the years, many invasive methods have been developed for the removal of caries. The advancements in dentistry have made it possible to conserve the maximum amount of tooth structure possible. Individuals with high dental anxiety are often unable to utilise standard dental health services and often leads to reduced oral health-related quality of life. In light of new chemo-mechanical agents available commercially, it is important to assess their clinical efficacy and anxiety associated with them. This study aims to evaluate the anxiety levels before and after caries removal by chemo-mechanical caries removal agent, atraumatic restorative treatment (ART) and conventional methods (Rotary handpiece). This randomized controlled trial will be conducted to assess anxiety before and after caries removal by a chemo-mechanical caries removal agent (V-Carie-Solve), atraumatic restorative treatment (ART) and conventional methods (Rotary handpiece) among 30 children aged 6-14 years, divided into 3 groups (n=10 per group) based on the parameters of degree of caries removal, time for caries removal and dental anxiety experienced before and after intervention. Degree of caries removal will be assessed with a caries dye (Prevest Reveal) and time per procedure will be recorded using a stopwatch. Dental anxiety will be assessed using Facial Image Scale (FIS) before and after treatment. The data obtained will be entered into an excel sheet and appropriate statistical analysis would be carried out using SPSS v.26. |