Dental Game Impact on Kids' Pulpotomy Pain and Anxiety
Electronic
Effect of a Dental Simulation Game on Reducing Pain and Anxiety During Primary Teeth Pulpotomy in Pediatric Patients: A Randomized Controlled Clinical Study
1 other identifier
interventional
44
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
July 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2025
CompletedFirst Posted
Study publicly available on registry
July 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2025
CompletedJuly 18, 2025
July 1, 2025
6 months
July 9, 2025
July 17, 2025
Conditions
Keywords
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
EXPERIMENTAL22 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
Tell show do
OTHER22 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.
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.
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
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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