Evaluation of the Effectiveness of New Management Techniques in Reducing Dental Anxiety for Children Undergoing Pulpotomy

Evaluation of the Effectiveness of Kaleidoscope and Tell-Show-Play-Doh in Reducing Dental Anxiety for Children Undergoing Pulpotomy in Primary Molars - a Randomized Controlled Clinical Trial

The goal of this clinical trial is to reduce dental anxiety for sixety six children undergoing pulpotomy in primary molars by using kaleidoscope glasses and Tell-Show-Play-Doh techniques and evaluation of behavior and anxiety achieved by using FLAAC scale, measuring heart rate and RMS-Pictorial scale.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: Group 1 (Tell-Show-Do); Behavioral: The Play-Doh Doctor Drill 'n Fill toy set; Behavioral: Using Kaleidoscope glasses during pulpotomy procedures

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt., Egypt
    • Faculty of Dentistry, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: 1. Children attended the dental clinic for their first time.

2. Children aged between 4 to 6 years including both boys and girls. 3. Healthy Children with Frankl's behavior rating score 2,3 and 4 of Frankl's behavior rating scale and no prior dental experience.

4. Children with carious lesions in lower restorable primary molars and indicated for pulpotomy.

- Exclusion Criteria: 1.Children with known significant visual impairments or psychological problems.

2. Children suffering from systemic diseases or special health care needs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 (Tell-Show-Do)	Other: Group 1 (Tell-Show-Do); In which Tell-Show-Do technique was done in three stages: Tell: The dental procedures were explained to the children using language and expressions appropriate for their age.; Show: This began with showing the child the instruments and the topical anesthetic gel, high-speed handpiece and explaining the purpose of using the handpiece. and how the water removed using the suction device.; Do: Performing the dental procedure immediately.
Experimental: Group 2 ( Tell-Show-Play-Doh)	Behavioral: The Play-Doh Doctor Drill 'n Fill toy set; Consists of a plastic human head with slots into which Play-doh molded teeth can be inserted. A battery operated toy drill is used to drill into and clean the black, cavitated tooth model and filled with white Play-Doh compound to simulate cavity preparation and restoration using tooth colored cement.
Experimental: Group 3 (Kaleidoscope glasses )	Behavioral: Using Kaleidoscope glasses during pulpotomy procedures; Kaleidoscope is an instrument that shows an infinite number of fascinating geometric shapes in the form of a flower, repeating and reflecting images of coloured goggle fragments in the front section in a prism mirroring the inner surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of behavior of the child before and during and after the pulpotomy procedures.	Assessment of behavior of the child using ( Frankl's behavior rating scale to measure the cooperation behavior of the child, FLACC scale ).; Frankl's behavior rating scale was used pre-operatively and post-operatively with 4 scores : score 1(Definitely negative) score 2(Negative) score 3(Positive) score 4 (Definitely positive), the best scores for positive attitude and cooperation are score 3, 4.; The FLACC scale was used to measure behavior of the child according to Face, Legs, Activity, Cry and Consolability during the pulpotomy procedures with Scores: (0 = Relaxed and comfortable) (1-3 = Mild discomfort ) (4-6 = Moderate pain) (7-10 = Severe discomfort/pain).	Pre-operatively , during the procedure and post-operatively at the end of the visit at the same visit with no follow up.
Assessment of anxiety of the child before and after the pulpotomy procedures.	Assessment of anxiety of the child using (Pulse Oximeter to measure heart rate pre-operatively and post-operatively, RMS Pictorial Scale at the end of the visit). Increasing in heart rate readings means increasing anxiety.; RMS Pictorial Scale which comprises a row of five faces ranging from score 1(very happy) to score 5 (very unhappy) and the children were asked to choose the face they felt like about themselves at that moment.	Pre-operatively and post-operatively at the end of the visit at the same visit with no follow up.

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2023
• Primary Completion (Actual): March 9, 2024
• Study Completion (Actual): September 15, 2024

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Childhood dental anxiety, Behavior management.
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: A01011023PP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No