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Comparison of three behavior management techniques in reducing dental anxiety in children during dental restorative procedure.

Phase 3
Not yet recruiting
Conditions
Dental caries on pit and fissure surface,
Registration Number
CTRI/2023/08/056457
Lead Sponsor
Dr Prachi Mujariya
Brief Summary

Dental anxiety, anonspecific feeling of worry occurs during child’s first dental visit sincethey are new to dental environment and do not have any previous experience. Thechild’s first visit, negatively influences further treatment so behaviormodelling at first visit plays a pivotal role. Fora 5–7 year old child it is difficult to perceive an idea, for which he has noconceptual framework so as to understand dentist’s frame of reference. So instead of onlyexplaining or demonstrating, making them play with the dental instrumentimitating toys on a friendly attractive model like hand puppets, provides anexplanatory concept. Theuse of puppets has historically provided play therapists and health careprofessionals with a tool to observe, educate and support children. With this idea TSDwas modified to Tell-play-do (TPD) technique using concept of learning by doing. Gray and Garand’searly recommendations emphasized the importance of stories written from the child’s perspective andpresented in a print size appropriate for the child in order for the child tounderstand the dentist’s frame of reference and correlate with them in a mucheasier way.

AIM- Toevaluate and compare the effectiveness of customized Tell-play-do, storybookmodelling and conventional Tell-Show-Do behavior management techniques in themanagement of 5–7 year old anxious patients at their first dental visit in thepediatric practice.

METHOD- Completecase history of the patient will be taken. Patientwill be evaluated based on Frankl’s behavior rating scale.  Patientwill be evaluated randomly in different 3 groups.Thisstudy will be conducted by using randomized controlled trial.

120 Children agedbetween 5 to 7 years following inclusion criteria will be selected using convenience sampling method. 

**Sampleswill be divided into the following groups;**

**Group I**: Children prepared for dental treatment by **Tell-play-dotechnique.**

**Group II**: Children prepared for dental treatment by **Dental StorybookModelling.**

**Group III:** Children prepared for dental treatment by **ConventionalTell-Show-Do technique.**

The studywill 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. Theanxiety level will be checked by measuring Heart Rate, Oxygen saturationSP02(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, StandardDeviation for quantitative variables while frequency and percentages will beused to summarize qualitative (Categorical) variables.Inferential statistics will include P-values resulting from hypothesistesting procedures. Proportions for important qualitative parameters like behavior etc. willbe estimated in each group in percentage along with 95% Confidence Intervals.

Ø  Chi-square test will be used for comparing difference in proportions inthree independent groups for qualitative/categorical outcome variables. Between-the – groups comparison of mean difference in quantitativeoutcome variables across 3 groups will be evaluated with One-way ANOVA andF-test.  Post hoc Bonferroni MultipleComparison test will be used for performing all possible pair-wise comparisons. Within-the-group comparison of change in quantitative parameters likefrom baseline to 7 days will be performed by Paired t-test.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
120
Inclusion Criteria
  • 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.
  • 6.Patients having Class I carious cavity lesion in one of the primary molars and needs restoration.
Exclusion Criteria
  • 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod
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.

Trial Locations

Locations (1)

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital

🇮🇳

Nagpur, MAHARASHTRA, India

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Dr Prachi Mujariya
Principal investigator
8208753179
mujariyaprachi@gmail.com

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