NCT07072559

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 9, 2025

Last Update Submit

July 17, 2025

Conditions

Keywords

dental gamepulpotomypainanxietytell show do

Outcome Measures

Primary Outcomes (4)

  • 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

    behavior of child will be assessed at baseline .same visit

  • 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.

    anxiety of child will be assessed at baseline .same visit

  • Wong baker scale

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

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

  • 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

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

Study Arms (2)

Dental simulation game

EXPERIMENTAL

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

Tell show do

OTHER

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

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
Dental simulation game

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
Tell show do

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of Dentistry, Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Interventions

Protein-Arginine DeiminasesDC-tell

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrolasesEnzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 18, 2025

Study Start

January 30, 2025

Primary Completion

July 15, 2025

Study Completion

August 15, 2025

Last Updated

July 18, 2025

Record last verified: 2025-07

Locations