Dental Play Intervention Before Restorative Care in Children (Dental Play)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Anxiety in Children
• Intervention / Treatment: Behavioral: Structured dental play session prior to restorative dental treatment.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Participants will proceed with their restorative appointment as scheduled, without any dental play intervention.
Experimental: Intervention Group; 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.	Behavioral: Structured dental play session prior to restorative dental treatment.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the impact on play therapy for dental patients	To understand the impact on play therapy for dental patients according to the quantitative Houpt Behavior rating scale.	1.5 hours

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: Gayatri Malik, DMD, PhD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026-0547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No