AnxietyAATNCT05464888
Animal Assisted Therapy in Pediatric Dentistry
A study testing +Short AAT and +Long AAT in people with Anxiety, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- +Short AAT and +Long AAT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2023to Feb 2028
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
General & Oral Health Center
Chapel Hill, North Carolina, 27599
S.T. Phillips, BSDH, 919-537-3422, sherrill_phillips@unc.edu
About this study
Official title: Animal Assisted Therapy's Effects on Young Dental Patients
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.
Read the detailed description
Patients will be consented, enrolled, and randomly assigned to a control group (no dog) or to an experimental group with dog present only before their dental visit for 3 minutes (+ Short AAT) or to an experimental group with dog present throughout their entire visit (+ Long AAT). Control (no dog) patients will have an active control where they color for 3 minutes before their dental exam, cleaning, and simulated radiographs, without a dog present. Biometric data will be collected with a small wireless wrist device (Shimmer 3) which measures heart rate and sweat response (skin galvanic response). Salivary samples will be taken before and after the dental visit to measure salivary cortisol and amylase, as a metric of physiological stress. Finally, a video feed of body movements during the dental visit will be collected for observational coding. Pre-visit and post-visit surveys will be given to all the patients on their experiences regarding pain, anxiety, and perceptions of the dental experience.
- Conditions
- Anxiety
- Being tested
- +Short AAT, +Long AAT, Active control; NO dog
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
+Short AATBehavioural
Interaction with therapy dog prior to dental exam, cleaning, and simulated radiographs.
+Long AATBehavioural
Interaction with therapy dog throughout dental exam, cleaning, and simulated radiographs.
Active control; NO dogBehavioural
Color dog picture for 3 minutes prior to dental exam, cleaning, and simulated radiographs.
| Study group | Role | What they receive |
|---|---|---|
| +Short AAT | Experimental | Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 experimental patients who will be interacting with the dog prior to their oral exam. Receives: Behavioral: +Short AAT |
| +Long AAT | Experimental | Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 experimental patients who will be interacting with the dog throughout their entire visit. Receives: Behavioral: +Long AAT |
| Active control; NO dog | Active comparator | Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 control patients who will not be interacting with the dog during their visit and will color a dog picture for 3 minutes instead. Receives: Behavioral: Active control; NO dog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Heart Rate during Dental Exam
Beats per minute during dental exam. Heart rate measured using wrist-worn Shimmer heart rate tracking device.
Measured: During dental exam, approximately 2- 5 minutes.
Mean Heart Rate during Dental Cleaning
Beats per minute during dental cleaning. Heart rate measured using wrist-worn Shimmer heart rate tracking device.
Measured: During dental cleaning, approximately 2- 5 minutes.
Mean Heart Rate during Dental Radiograph Simulation
Beats per minute during dental radiograph simulation. Heart rate measured using wrist-worn Shimmer heart rate tracking device.
Measured: During dental radiograph simulation, approximately 2- 5 minutes.
Salivary Cortisol during Dental Exam
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.
Measured: During dental exam, approximately 1-2 minutes.
Salivary Cortisol during Dental Cleaning
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.
Measured: During dental cleaning, approximately 1-2 minutes.
Salivary Cortisol during Dental Radiograph Simulation
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.
Measured: During dental radiograph simulation, approximately 1-2 minutes.
Salivary Amylase during Dental Exam
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.
Measured: During dental exam, approximately 1-2 minutes.
Salivary Amylase during Dental Cleaning
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.
Measured: During dental cleaning, approximately 1-2 minutes.
Salivary Amylase during Dental Radiograph Simulation
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.
Measured: During dental radiograph simulation, approximately 1-2 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start2 Feb 2023
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Laura A Jacox, DMD, PhD, MS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464888
- Sponsor's protocol ID
- 22-1454
- Other IDs
- UL1TR002489, K08DE030235, R03DE032768
- Acronym
- AAT
- Status last verified
- Jun 2026
- First submitted
- 15 Jul 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Kapov G, Linton K, Gatewood C, Liu C, Strauman T, Hodges E, Graves C, Sawicki C, Wu D, Divaris K, Jacox LA. Effects of animal-assisted therapy on dental anxiety, behavior, and perceptions in young pediatric patients: a blinded randomized controlled trial. Trials. 2025 Aug 7;26(1):279. doi: 10.1186/s13063-025-08970-z.
PubMed 40775655
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animal Assisted Therapy's Effects on Young Dental Patients
- ClinicalTrials.gov ID
- NCT05464888
- Acronym / sponsor ID
- AAT / 22-1454
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 19 Jul 2022 (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.
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.
Detailed description
Patients will be consented, enrolled, and randomly assigned to a control group (no dog) or to an experimental group with dog present only before their dental visit for 3 minutes (+ Short AAT) or to an experimental group with dog present throughout their entire visit (+ Long AAT). Control (no dog) patients will have an active control where they color for 3 minutes before their dental exam, cleaning, and simulated radiographs, without a dog present. Biometric data will be collected with a small wireless wrist device (Shimmer 3) which measures heart rate and sweat response (skin galvanic response). Salivary samples will be taken before and after the dental visit to measure salivary cortisol and amylase, as a metric of physiological stress. Finally, a video feed of body movements during the dental visit will be collected for observational coding. Pre-visit and post-visit surveys will be given to all the patients on their experiences regarding pain, anxiety, and perceptions of the dental experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| +Short AAT | Experimental | Behavioral: +Short AATChildren aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 experimental patients who will be interacting with the dog prior to their oral exam. |
| +Long AAT | Experimental | Behavioral: +Long AATChildren aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 experimental patients who will be interacting with the dog throughout their entire visit. |
| Active control; NO dog | Active comparator | Behavioral: Active control; NO dogChildren aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 control patients who will not be interacting with the dog during their visit and will color a dog picture for 3 minutes instead. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| +Short AATInteraction with therapy dog prior to dental exam, cleaning, and simulated radiographs. | Behavioural | +Short AAT |
| +Long AATInteraction with therapy dog throughout dental exam, cleaning, and simulated radiographs. | Behavioural | +Long AAT |
| Active control; NO dogColor dog picture for 3 minutes prior to dental exam, cleaning, and simulated radiographs. | Behavioural | Active control; NO dog |
Primary outcome
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.
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 12 Jun 2026.
- Derived from this study: PubMed 40775655Kapov G, Linton K, Gatewood C, Liu C, Strauman T, Hodges E, Graves C, Sawicki C, Wu D, Divaris K, Jacox LA. Effects of animal-assisted therapy on dental anxiety, behavior, and perceptions in young pediatric patients: a blinded randomized controlled trial. Trials. 2025 Aug 7;26(1):279. doi: 10.1186/s13063-025-08970-z.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Laura A Jacox, DMD, PhD, MS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing +Short AAT and +Long AAT in people with Anxiety, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Laura A Jacox, DMD, PhD, MS (919-537-3424, ljacox@live.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Heart Rate during Dental Exam (time frame: During dental exam, approximately 2- 5 minutes.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05464888, which also lists 1 linked publication.
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 12 Jun 2026.