Dental Anxiety in ChildrenDental PlayNCT07702045
Dental Play Intervention Before Restorative Care in Children
A study testing Structured dental play session prior to restorative dental treatment. in people with Dental Anxiety in Children, run by Geisinger Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Dental Anxiety in Children
- What is being tested?
- Structured dental play session prior to restorative dental treatment.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Dental Anxiety in Children
- Being tested
- Structured dental play session prior to restorative dental treatment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured dental play session prior to restorative dental treatment.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Structured dental play session prior to restorative dental treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Anxiety in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gayatri Malik, Geisinger Clinic
- Investigators
- Gayatri Malik, DMD, PhD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702045
- Sponsor's protocol ID
- 2026-0547
- Acronym
- Dental Play
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Play Intervention Before Restorative Care in Children
- ClinicalTrials.gov ID
- NCT07702045
- Acronym / sponsor ID
- Dental Play / 2026-0547
- Conditions
- Dental Anxiety in Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants will proceed with their restorative appointment as scheduled, without any dental play intervention. |
| Intervention Group | Experimental | 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gayatri Malik, DMD, PhD principal investigator
Geisinger Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Structured dental play session prior to restorative dental treatment. in people with Dental Anxiety in Children, run by Geisinger Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the impact on play therapy for dental patients (time frame: 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.