| CTRI Number |
CTRI/2022/09/045359 [Registered on: 08/09/2022] Trial Registered Prospectively |
| Last Modified On: |
08/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Roogies app and Tell-Show-Do method in decreasing Dental anxiety in children |
|
Scientific Title of Study
|
The Efficacy of Roogies dental app and Tell-Show-Do Techniques in Alleviating Dental Anxiety in Pediatric Patients: A Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rusheeka Kake |
| Designation |
Post Graduate |
| Affiliation |
Narayana Dental College and Hospital, Nellore |
| Address |
Narayana Dental College and Hospital
Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8919057717 |
| Fax |
|
| Email |
rusheeka67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SIVAKUMAR NUVVULA |
| Designation |
MDS, FICD, Guide, Professor and Head of the department |
| Affiliation |
Narayana Dental College and Hospital, Nellore |
| Address |
Narayana Dental College and Hospital
Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441624429 |
| Fax |
|
| Email |
dentist4kids@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rusheeka Kake |
| Designation |
Post Graduate |
| Affiliation |
Narayana Dental College and Hospital, Nellore |
| Address |
Narayana Dental College and Hospital
Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8919057717 |
| Fax |
|
| Email |
rusheeka67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatric and Preventive Dentistry,
Room number: 6,
Narayana Dental College and Hospital,
Nellore,
Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Rusheeka Kake |
| Address |
Narayana Dental College and Hospital
Nellore
Andhra Pradesh |
| Type of Sponsor |
Other [Self-Sponsored] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rusheeka Kake |
Narayana Dental College and Hospital |
Department of Pediatric and Preventive Dentistry
Room number:6
Nellore
ANDHRA PRADESH |
8919057717
rusheeka67@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee NDCH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Roogies dental app |
Roogies dental app is a technological tool for behavior management during dental procedures and it demonstrates dental procedures in the form of video for a period of five minutes |
| Comparator Agent |
Tell-Show-Do(TSD) technique |
TSD is the conventional technique for the behavior management during the dental procedures for a period of five minutes |
|
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Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1.Children without any prior experience with the dental treatment procedures.
2.Children who comes under frankl behavior rating 2 and 3.
|
|
| ExclusionCriteria |
| Details |
1.Children with any systemic disorders or special health care needs.
2.Children or parents who refused to participate in the study.
3.Children who complain of pain.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate will be measured using pulse oximeter,
which is a physiological representation of anxiety
or fear |
1. Before intervention-Baseline(Roogies dental app/Tell-Show-Do)
2. After 5 minutes of intervention(Roogies dental app/Tell-Show-Do)
3. After the dental procedure (30 minutes) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Facial Image Scale(FIS) and RMS scale will be used to measure anxiety, which is a subjective measure |
1. Before intervention-Baseline(Roogies dental app/Tell-Show-Do)
2. After 5 minutes of intervention(Roogies dental app/Tell-Show-Do)
3. After the dental procedure(30 minutes) |
|
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Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
12/09/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dental anxiety in children presents a challenge to the child, parents and the dental team. The children who suffer from dental anxiety and fear range from 5 to 33% throughout the world and are ranked as the fourth common fear. The first dental visit is crucial in the formation of the child’s attitude toward dentistry and future treatment success. Therefore, a pleasant experience normally generates a sense of ease and trust in the dentist, while a traumatic experience leads to avoidance of visiting the dentist. Behavior guidance is a teaching technique that requires interactions between the dentist, dental team, patient, and parents. Tell-show-do technique, introduced by Addelston in 1959, remains the cornerstone of behavior management techniques. With the advancement in technology, mobile dental apps that are used for behavior guidance has led to the development of virtual reality immersion. A novel, Roogies dental app which is based on cognitive-behavioral techniques such as systematic desensitization, modelling, distraction and guided imagery is created. Aim: To evaluate and compare the efficacy of Roogies dental app and TSD in the management of child’s dental anxiety Objectives: 1. To obtain anxiety levels in the two groups before, immediately after intervention and after completion of the procedure using physiological(Heart rate by pulse oximeter) and subjective(FIS and RMS scale) measures. 2. To compare the anxiety levels in the two groups before, immediately after the intervention, and after completion of the procedure using physiological (Heart rate by pulse oximeter) and subjective(FIS and RMS scale) measures. 3. To compare the anxiety levels using the Facial image scale (FIS) and RMS scale. Methodology: 52 Children aged 6-11 years attending the Department of Paediatric and Preventive Dentistry who are indicated for restorative procedures will be divided into two groups(26 per each group) by simple random sampling. Before including them in the trial, informed and written consent was taken from the child’s parents or guardians. Group I: "Roogies" mobile dental app Group II: Conventional Tell-Show-Do technique The Roogies app is a technological behaviour guidance tool, and it was created taking into account cognitive-behavioural principles. Roogies application demonstrates the procedures such as Atraumatic restorative treatment, conventional dental filling, and placement of crowns of each treatment step in the form of video. For the tell-show-do technique, in the "tell" part, there is a verbal explanation for the dental procedure appropriate to the child’s developmental level. In the "show" aspect, demonstration of various instruments was provided to the child in a friendly style to build their confidence and lastly, in the "do" part, the dentist performed the desired procedure precisely as explained to the child. As explained during the intervention, dental restorative procedures will be performed on all the participants. The anxiety levels will be recorded before, immediately after intervention and after completion of the procedure using physiological (pulse oximeter) and subjective (FIS and RMS scale).
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