NCT05464888 · University of North Carolina, Chapel Hill
Animal Assisted Therapy in Pediatric Dentistry
(AAT)
What this study is about
A forward-looking randomly assigned trial measuring physiologic biometrics and perceptions of stress during a pediatric dental exam, cleaning, and simulated radiographs with or without a therapy dog present.
View original scientific description
A prospective randomized trial measuring physiologic biometrics and perceptions of stress during a pediatric dental exam, cleaning, and simulated radiographs with or without a therapy dog present.
Interventions
BEHAVIORAL
+Short AAT
Interaction with therapy dog prior to dental exam, cleaning, and simulated radiographs.
BEHAVIORAL
+Long AAT
Interaction with therapy dog throughout dental exam, cleaning, and simulated radiographs.
BEHAVIORAL
Active control; NO dog
Color dog picture for 3 minutes prior to dental exam, cleaning, and simulated radiographs.
Primary outcome measures
Mean Heart Rate during Dental Exam
Time frame: During dental exam, approximately 2- 5 minutes.
Beats per minute during dental exam. Heart rate measured using wrist-worn Shimmer heart rate tracking device.
Mean Heart Rate during Dental Cleaning
Time frame: During dental cleaning, approximately 2- 5 minutes.
Beats per minute during dental cleaning. Heart rate measured using wrist-worn Shimmer heart rate tracking device.
Mean Heart Rate during Dental Radiograph Simulation
Time frame: During dental radiograph simulation, approximately 2- 5 minutes.
Beats per minute during dental radiograph simulation. Heart rate measured using wrist-worn Shimmer heart rate tracking device.
Salivary Cortisol during Dental Exam
Time frame: During dental exam, approximately 1-2 minutes.
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.
Salivary Cortisol during Dental Cleaning
Time frame: During dental cleaning, approximately 1-2 minutes.
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.
Salivary Cortisol during Dental Radiograph Simulation
Time frame: During dental radiograph simulation, approximately 1-2 minutes.
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.
Salivary Amylase during Dental Exam
Time frame: During dental exam, approximately 1-2 minutes.
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.
Salivary Amylase during Dental Cleaning
Time frame: During dental cleaning, approximately 1-2 minutes.
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.
Salivary Amylase during Dental Radiograph Simulation
Time frame: During dental radiograph simulation, approximately 1-2 minutes.
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
- 4-8 years of age
- English speaking
- Qualifies for a dental exam and prophylaxis (cleaning) by having not received a dental prophylaxis or oral exam in the past 3 months
- Stable physical health, decided at the discretion of the study coordinator and PI
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based on research site personnel's assessment
- Evidence of a personally signed and dated informed assent form from the child and legal guardian's consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all of their questions have been answered
Exclusion criteria
- Subjects presenting with any of the following will not be included in the study:
- Patients \<4yo and \>8yo
- Non-English speakers
- Patients unwilling to assent/participate or parental/guardian consent was not given
- Self-report or parental report of patient suffering current dental pain
- Known allergies or significant adverse reactions following exposure to dogs or the use of oral hygiene products (toothpastes, mouth rinses), and all ingredients in prophy paste
- Children who are afraid of dogs or had a prior negative experience with dogs as reported by the parent or child
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial
- Developmental/cognitive disability such that patient cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment
Where
- Chapel Hill, North Carolina
Collaborators
National Center for Advancing Translational Sciences (NCATS), National Institute of Dental and Craniofacial Research (NIDCR)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations