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

NCT06673030 | Completed

• 1 other identifier: A01011023PP
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety

Keywords

Childhood dental anxiety, Behavior management.

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

Group 1 (Tell-Show-Do)

ACTIVE COMPARATOR

Other: Group 1 (Tell-Show-Do)

Group 2 ( Tell-Show-Play-Doh)

EXPERIMENTAL

Behavioral: The Play-Doh Doctor Drill 'n Fill toy set

Group 3 (Kaleidoscope glasses )

EXPERIMENTAL

Behavioral: Using Kaleidoscope glasses during pulpotomy procedures

Interventions

Using Kaleidoscope glasses during pulpotomy procedures BEHAVIORAL

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.

Group 3 (Kaleidoscope glasses )

The Play-Doh Doctor Drill 'n Fill toy set BEHAVIORAL

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.

Group 2 ( Tell-Show-Play-Doh)

Group 1 (Tell-Show-Do) OTHER

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.

Group 1 (Tell-Show-Do)

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \. Children suffering from systemic diseases or special health care needs.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura university

Mansoura, Egypt., Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree student, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Mansoura University

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 4, 2024
• Study Start: August 5, 2023
• Primary Completion: March 9, 2024
• Study Completion: September 15, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)