| CTRI Number |
CTRI/2023/08/056457 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Comparison of three behavior management techniques in reducing dental anxiety in children during dental restorative procedure. |
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Scientific Title of Study
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TO EVALUATE AND COMPARE THE EFFECT OF TELL-PLAY-DO, STORYBOOK MODELLING AND TELL-SHOW-DO TECHNIQUES ON DENTAL ANXIETY DURING DENTAL RESTORATIVE PROCEDURE IN 5-7 YEAR OLD PATIENTS: A RANDOMIZED CONTROLLED TRIAL. |
| Trial Acronym |
NILL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prachi Mujariya |
| Designation |
Postgraduate student |
| Affiliation |
Swargiya Dadasaheb kalmegh smruti dental college and hospital. |
| Address |
Second floor, 202, Department of Pediatric and Preventive Dentistry, Swargiya Dadasaheb kalmegh smruti dental college and hospital, Hingna, Nagpur, Maharashtra, 441110, India.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8208753179 |
| Fax |
|
| Email |
mujariyaprachi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Arunkumar Sajjanar |
| Designation |
Head of Department of Pediatric and Preventive Dentistry |
| Affiliation |
Swargiya Dadasaheb kalmegh smruti dental college and hospital. |
| Address |
Second floor, 202, Department of Pediatric and Preventive Dentistry, Swargiya Dadasaheb kalmegh smruti dental college and hospital, Hingna, Nagpur, Maharashtra, 441110, India.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9146768016 |
| Fax |
|
| Email |
arunsajju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Mujariya |
| Designation |
Postgraduate student |
| Affiliation |
Swargiya Dadasaheb kalmegh smruti dental college and hospital. |
| Address |
Second floor, 202, Department of Pediatric and Preventive Dentistry, Swargiya Dadasaheb kalmegh smruti dental college and hospital, Hingna, Nagpur, Maharashtra, 441110, India.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8208753179 |
| Fax |
|
| Email |
mujariyaprachi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya dadasaheb kalmegh smruti dental college and hospital, Hingna, Nagpur, Maharashtra. |
|
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Primary Sponsor
|
| Name |
Dr Prachi Mujariya |
| Address |
Second floor, 202, Department of Pediatric and Preventive Dentistry, Swargiya dadasaheb kalmegh smruti dental college and hospital, Hingna, Nagpur, Maharashtra, 441110, India. |
| Type of Sponsor |
Other [[self]] |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prachi Mujariya |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
Room no. 202, Department of Pediatric and Preventive Dentistry
Nagpur
MAHARASHTRA |
8208753179
mujariyaprachi@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDKS DCH Institutional Ethical Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Storybook modelling behavior management technique. |
Child will be directed towards the operatory room, the dental storybook designed by me will be read aloud by child along with the visual pictures in it allowing the audiovisual behavior modelling based on the behavior learnt from the lead cartoon character of the storybook.
Also, the child will learn various dental procedures shown through animated pictures and euphemisms for instruments thus attempting to reduce the dental anxiety.
Self designed dental storybook will address following areas: oral conditions, diagnostic and restorative and preventive dental procedures.
The storybook will be designed to prepare children for their first dental visits. It will utilize a specific color scheme intertwined with cartoon characters to assist in building the narrative. The book will describe and explain various stages and peripherals attached to the first dental visit, including an examination (prophylaxis and topical fluoride). The story will be written in simple language describing the waiting area, the dentist’s and dental assistant’s roles, the instruments and their uses and the clinic. The goal is to familiarize children with the dental visits.
The duration of this will be standardized for 15 minutes.
The anxiety level will be checked by measuring Heart Rate, Oxygen saturation SP02(using Microtek finger oximeter), and Facial Image Scale before , during and after intervention in first(oral prophylaxis done) and second (dental restoration done) visits.
|
| Intervention |
Tell- Play- Do behavior management technique |
The child will be taken to the play area, where the customized Puppet-clay-play model set will be introduced to child which consists of a cotton cloth hand puppet with pink play-clay molded gingiva with inserted acrylic teeth set. Along with attractive dental imitating instrument toys like diagnostic(mouth mirror, explorer, probe), airotor, cement carrier, spoon excavator, three-way syringe and suction tips from colored play-clay.
A black play-clay will be placed over the teeth resembling caries and yellow play-clay over labial surfaces resembling dental plaque.
TELL- The child will be explained about all the dental imitating instruments and objects using appropriate euphemisms and procedures in phrases appropriate to the developmental level of the child.
SHOW-Then child will be shown or demonstrated various dental procedures on the hand puppet with appropriate instrument. Also, the noise will be incorporated in the dental object resembling a clinical sound effect.
PLAY- Child will be allowed to play with the Puppet-clay-play model set, like removing the yellow deposits over teeth and drilling out the black clay and putting white clay resembling cement; so as to understand the dentist’s frame of reference.
DO- Patient will be taken to operatory room to perform oral prophylaxis.
The duration of this will be standardized for 15 minutes.
The anxiety level will be checked by measuring Heart Rate, Oxygen saturation SP02(using Microtek finger oximeter), and Facial Image Scale before, during and after intervention and at first (oral prophylaxis done) and second (dental restoration) visits.
|
| Comparator Agent |
Tell- Show- Do behavior management technique. |
Child will be made to sit on dental chair then:
TELL- Child will be explained exactly what procedure is going to be done using calm voice, in words that they can understand like plaque becomes sugar bugs, air rotor becomes whistle brush.
SHOW- Then the child will be shown or demonstrated the visual, auditory and tactile aspects of procedure on the dental cast.
DO- When the child will be finally ready to accept the treatment, oral prophylaxis will be performed.
The anxiety level will be checked by measuring Heart Rate, Oxygen saturation SP02(using Microtek finger oximeter), and Facial Image Scale before, during and after intervention in first ( oral prophylaxis done) and second ( dental restoration done) visits.
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Inclusion Criteria
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| Age From |
5.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects in the age group of 5-7 years.
2.Patients at their first dental visit.
3.Patients with Frankel’s behavior rating score of 2 or 3.
4.No history of previous hospitalization or previous dental treatment.
5.Patients with prior parental consent.
6.Patients having Class I carious cavity lesion in one of the primary molars and needs restoration.
|
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| ExclusionCriteria |
| Details |
1.Medically compromised patient.
2.Patients with previous dental history.
3.Patients with Frankl’s behavior rating score of 1 or 4.
4.Patients with previous history of hospitalization.
 Psychological impairment.
 Patients requiring pharmacological management.
5.Patients undergoing medical treatment that might affect heart rate (HR)and those with heart disorders.
6.Teeth which needs invasive procedure.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is to assess the difference in the effect of Customized Tell-play-do, storybook modelling & conventional tell-show-do technique on reducing dental anxiety in 5-7 year old patients during dental restorative procedure. |
Specific time at which outcome will be assessed or estimated, that is at baseline 8 weeks. intervention. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is to measure which behavior management technique among Customized TPD, storybook modelling & TSD is better in reducing dental anxiety in 5-7 year old patients during dental restorative procedure. |
Specific time at which outcome will be assessed or estimated, that is before & after 16 weeks of intervention. |
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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" |
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Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/08/2023 |
| 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="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Dental anxiety, a
nonspecific feeling of worry occurs during child’s first dental visit since
they are new to dental environment and do not have any previous experience. The
child’s first visit, negatively influences further treatment so behavior
modelling at first visit plays a pivotal role. For
a 5–7 year old child it is difficult to perceive an idea, for which he has no
conceptual framework so as to understand dentist’s frame of reference. So instead of only
explaining or demonstrating, making them play with the dental instrument
imitating toys on a friendly attractive model like hand puppets, provides an
explanatory concept. The
use of puppets has historically provided play therapists and health care
professionals with a tool to observe, educate and support children. With this idea TSD
was modified to Tell-play-do (TPD) technique using concept of learning by doing. Gray and Garand’s
early recommendations emphasized the importance of stories written from the child’s perspective and
presented in a print size appropriate for the child in order for the child to
understand the dentist’s frame of reference and correlate with them in a much
easier way. AIM- To
evaluate and compare the effectiveness of customized Tell-play-do, storybook
modelling and conventional Tell-Show-Do behavior management techniques in the
management of 5–7 year old anxious patients at their first dental visit in the
pediatric practice. METHOD- Complete
case history of the patient will be taken. Patient
will be evaluated based on Frankl’s behavior rating scale. Patient
will be evaluated randomly in different 3 groups.This
study will be conducted by using randomized controlled trial.
120 Children aged
between 5 to 7 years following inclusion criteria will be selected using convenience sampling method. Samples
will be divided into the following groups;
Group I: Children prepared for dental treatment by Tell-play-do
technique.
Group II: Children prepared for dental treatment by Dental Storybook
Modelling.
Group III: Children prepared for dental treatment by Conventional
Tell-Show-Do technique.
The study
will be divided into 2 visits. All interventions will be performed in each group at first dental visit, and recalled after 7 days for restorative procedure. The
anxiety level will be checked by measuring Heart Rate, Oxygen saturation
SP02(using Microtek finger oximeter),
and Facial Image Scale before, during and after intervention in first and second visits. Descriptive statistics will include summary measures like Mean, Standard
Deviation for quantitative variables while frequency and percentages will be
used to summarize qualitative (Categorical) variables.Inferential statistics will include P-values resulting from hypothesis
testing procedures. Proportions for important qualitative parameters like behavior etc. will
be estimated in each group in percentage along with 95% Confidence Intervals. Ø Chi-square test will be used for comparing difference in proportions in
three independent groups for qualitative/categorical outcome variables. Between-the – groups comparison of mean difference in quantitative
outcome variables across 3 groups will be evaluated with One-way ANOVA and
F-test. Post hoc Bonferroni Multiple
Comparison test will be used for performing all possible pair-wise comparisons. Within-the-group comparison of change in quantitative parameters like
from baseline to 7 days will be performed by Paired t-test.
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