Dental Play Intervention Before Restorative Care in Children

NCT07702045 | Not Yet Recruiting

• 1 other identifier: 2026-0547
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dental Anxiety in Children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Group

NO INTERVENTION

Participants will proceed with their restorative appointment as scheduled, without any dental play intervention.

Intervention Group

EXPERIMENTAL

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.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Officials

• Gayatri Malik, DMD, PhD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Dentist

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share