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Enrolling by Invitation

NCT Number: NCT07072559

Dental Game Impact on Kids' Pulpotomy Pain and Anxiety

The aim of this study is to evaluate the effect of a dental simulation game on reducing pain and anxiety during primary teeth pulpotomy.

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of Dentistry, Mansoura University

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1- Children aged between 4 to 7 years of both sexes. 2- Children with behavior rating score 2 and 3 according to Frankl's behavior rating scale.

3- Children with carious lesions indicated for pulpotomy. 4- Restorable primary lower molars.

Exclusion criteria

  • 1- Children with special health care needs. 2- Children suffering from systemic diseases.

Treatment and study plan

dental simulation game

Other

At the first visit children will play on any procedure in dental simulation game, after that the child will be shown two animals, after which they virtually do a root canal procedure. Tasks include performing a dental X-ray, anesthetizing the tooth using a syringe, drilling decayed cavity and start pulp treatment, rinsing, pulp treatment and filling the tooth, applying light cure and finally polishing the teeth. The second visit for pulpotomy procedure will be scheduled two days after first visit. Children will be managed using the TSD (Tell-Show-Do) technique.

Other names: dental game, I pad, electronic device

tell show do

Other

For the control group (group 1) TSD (Tell-Show-Do) technique group, children will be managed with a verbal explanation and a friendly, non-threatening demonstration of the upcoming dental treatment. The "do" phase involved carrying out the dental procedure as per the prior explanation and demonstration

Other names: tell, show, do

Primary outcomes

  1. Frankl's behavior scale

    Time frame: behavior of child will be assessed at baseline .same visit

    The behavior of child will be assessed before treatment, after administration of local anesthesia and finally after pulpotomy using Frankl's behavior rating scale

  2. Venham scale

    Time frame: anxiety of child will be assessed at baseline .same visit

    Anxiety levels of child patient will be assessed by Venham scale. First, explain to patient of all group to select most suitable face that matched with level of anxiety after administration of local anesthesia and after pulpotomy procedure done.

  3. Wong baker scale

    Time frame: pain level of child will be assessed at baseline .same visit

    Pain levels of child patient will be assessed after administration of local anesthesia and finally after pulpotomy using Wong baker scale

  4. pulse rate

    Time frame: vital sign of child will be assessed at baseline.same visit

    Measuring the pulse rate will be by using finger pulse oximeter before treatment, after administration of local anesthesia and at the end of pulpotomy

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Effect of a Dental Simulation Game on Reducing Pain and Anxiety During Primary Teeth Pulpotomy in Pediatric Patients: A Randomized Controlled Clinical Study

Acronym: Electronic

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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