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Enrolling by invitationNCT07072559ElectronicUpdated Jul 18, 2025

Dental Game Impact on Kids' Pulpotomy Pain and Anxiety

An interventional study of dental simulation game and tell show do in Pulpotomies Primary Teeth, Anxiety and Pain, sponsored by Mansoura University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 4 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-18.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 5 months after the study started (first participant enrolled Jan 2025, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
4 Years to 7 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Pulpotomies Primary Teeth
  • Anxiety
  • Pain

Keywords

  • dental game
  • pulpotomy
  • pain
  • anxiety
  • tell show do
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 44 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • 1- Children with special health care needs. 2- Children suffering from systemic diseases.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Dental simulation game

    22 children For the experimental group (group 2) dental simulation game, use the dental simulation game as educational game about procedure this game includes multiple dental procedures like filling cavities, performing root canal treatments, extracting decayed teeth, and conducting orthodontic procedures for animalsAt 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: dental simulation game

  • Other
    Tell show do

    22 children 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: tell show do

Interventions

  • Otherdental simulation game

    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.

    Also known as: dental game, I pad, electronic device

  • Othertell show do

    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

    Also known as: tell, show, do

06

What researchers measure

Primary outcomes

  1. Frankl's behavior scale

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

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

  2. Venham scale

    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.

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

  3. Wong baker scale

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

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

  4. pulse rate

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

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

07

Study locations

1 site
  • faculty of Dentistry, Mansoura University
    Al Mansurah, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07072559
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Jul 18, 2025
Start date
Jan 30, 2025
Primary completion
Jul 15, 2025 (estimated)
Completion
Aug 15, 2025 (estimated)
Last update
Jul 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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