Animal Assisted Therapy in Pediatric Dentistry
AAT
Animal Assisted Therapy's Effects on Young Dental Patients
1 other identifier
interventional
225
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started Feb 2023
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2022
CompletedFirst Posted
Study publicly available on registry
July 19, 2022
CompletedStudy Start
First participant enrolled
February 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
May 29, 2025
May 1, 2025
4 years
July 15, 2022
May 22, 2025
Conditions
Outcome Measures
Primary Outcomes (9)
Mean Heart Rate during Dental Exam
Beats per minute during dental exam. Heart rate measured using wrist-worn Shimmer heart rate tracking device.
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.
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.
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.
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.
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.
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.
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.
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.
During dental radiograph simulation, approximately 1-2 minutes.
Study Arms (3)
+Short AAT
EXPERIMENTALChildren 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
EXPERIMENTALChildren 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 COMPARATORChildren 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.
Interventions
Interaction with therapy dog prior to dental exam, cleaning, and simulated radiographs.
Interaction with therapy dog throughout dental exam, cleaning, and simulated radiographs.
Color dog picture for 3 minutes prior to dental exam, cleaning, and simulated radiographs.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General & Oral Health Center
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
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.
PMID: 40775655DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura A Jacox, DMD, PhD, MS
University of North Carolina, Chapel Hill
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2022
First Posted
July 19, 2022
Study Start
February 2, 2023
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
May 29, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- beginning 9 to 36 months following publication
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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.