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NCT Number: NCT07702045

Dental Play Intervention Before Restorative Care in Children

This pilot study designed to evaluate the feasibility and potential impact of play-based interventions on pediatric dental patients. The intervention consists of a structured dental play session prior to restorative treatment, aimed at reducing anxiety and improving behavioral cooperation. Data will be collected during and after the procedure, focusing on observed behavior and responses to standardized assessments.

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The purpose of this pilot study is to evaluate whether a structured dental play intervention can reduce dental anxiety and improve behavioral cooperation and treatment acceptance among pediatric patients undergoing restorative care. Dental play involves familiarizing children with common dental instruments-such as mirrors, composite guns, and acid etch containers-by allowing them to interact with these items before their procedure.

This prospective randomized controlled pilot study will include participants aged 3-6 years who present to the pediatric dental clinic for restorative treatment. Participants included will be American Society of Anesthesiologists (ASA) Physical Status I or II and have no pre-existing behavioral or neurological conditions that could influence anxiety or cooperation.

Participants will be randomly assigned in a 1:1 ratio to one of two groups: an intervention group receiving a pre-appointment dental play session with a Child Life Specialist, and a control group receiving standard care without play intervention.

Previous research in medical settings demonstrates that play-based interventions can reduce anxiety and enhance patient understanding of healthcare procedures. However, limited evidence exists regarding the effectiveness of such interventions in dentistry. This study aims to explore the feasibility and preliminary impact of dental play interventions on pediatric patient behavior during restorative treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with no neurodivergent diagnosis
  • Patients who at previous NP or hygiene visit has restorative needs that require administration of local anesthesia
  • Patients who are within a score of 2-5 on the Houpt Scale

Exclusion criteria

  • Patients with a diagnosed neurodivergent syndrome
  • Patients who do not need restorative work
  • Patients who are either score 1 or 6 on the Houpt Scale, to focus on patients with mild to moderate behavior challenges who may benefit most from the intervention.
  • Patients with complex medical history that affect behavior and cooperation

Treatment and study plan

Structured dental play session prior to restorative dental treatment.

Behavioral

Participants will arrive 30 minutes prior to their scheduled appointment and engage in a structured 30-minute dental play session with a Certified Child Life Specialist. The session will involve safe, non-functional dental materials such as white coats, gloves, mirrors, typodonts, and empty acid etch containers, allowing children to explore and interact with these items in a supportive environment.

Primary outcomes

  1. Measure the impact on play therapy for dental patients

    Time frame: 1.5 hours

    To understand the impact on play therapy for dental patients according to the quantitative Houpt Behavior rating scale.

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Acronym: Dental Play

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

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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