Animal Assisted Therapy in Dentistry
AAT
Animal Assisted Therapy's Effects on Dental Patients
1 other identifier
interventional
40
1 country
1
Brief Summary
A cross-sectional prospective study measuring physiologic biometrics and perceptions of stress during a dental procedure 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 below P25 for not_applicable anxiety
Started Jul 2021
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
January 11, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedStudy Start
First participant enrolled
July 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2024
CompletedResults Posted
Study results publicly available
August 19, 2024
CompletedAugust 19, 2024
March 1, 2024
1.9 years
January 11, 2021
March 22, 2024
March 22, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Mean Salivary Amylase Levels Throughout Dental Visit
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.
Up to end of dental visit; a total average between 60 to 90 minutes
Mean Salivary Cortisol Levels Throughout Dental Visit
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.
Up to end of dental visit; a total average between 60 to 90 minutes
Study Arms (2)
Control
NO INTERVENTIONNo exposure to the therapy dog.
Dog Therapy
EXPERIMENTALIntroduced to a therapy dog and allowed to pet the dog for up to 2 minutes (timed) prior to the dental procedure.
Interventions
The intervention is a therapy dog interaction (e.g. petting) for up to 2 minutes before their appointment and first interaction with the doctor. The subject can pet the dog for as long as they like up until the 2 minute mark.
Eligibility Criteria
You may qualify if:
- years of age
- Patient undergoing 1 quadrant restorative dental procedure requiring a handpiece (e.g. multiple fillings, sealants and/or stainless-steel crowns) and/or extraction(s)
- History of moderate dental anxiety with a Frankl score of 2-3 based on Epic chart review
You may not qualify if:
- Patients with developmental delay/special needs, Autism Spectrum Disorders (ASDs), craniofacial defects, chronic pain conditions, and/or dental syndromes
- No history of dental anxiety
- Moderate to severe allergy to dogs
- Previous traumatic experience with a dog and/or self-reported fear of dogs
- Patients who are not receiving dental care requiring a handpiece (for ex, prophylaxis only)
- Patients with severe, documented xerostomia
- Patients receiving sedation (pharmacological and conscious sedation) or general anesthesia
- Patients who will have physical restraints placed during the dental procedure
- Patient scheduled to have sedation or general anesthesia
- Severe acute or chronic medical or psychiatric condition(s) that would interfere with the interpretation of results, and in the judgement of the Investigator, would make the subject inappropriate for entry into the trial
- Patient with developmental/cognitive disability that cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment.
- Inability or unwillingness of individual and legal guardian/representative to give written informed assent (from child) and consent (from adult).
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)
Massouda J, Ghaltakhchyan N, Judd J, Bocklage C, Selden R, TumSuden O, Nanney E, Lee J, Ginnis J, Strauman T, Sawicki C, Hodges EA, Graves C, Divaris K, Jacox L. Evaluating effects of animal-assisted therapy on pediatric dental care patients: A pilot clinical trial. J Am Dent Assoc. 2025 Jun;156(6):447-457.e14. doi: 10.1016/j.adaj.2025.03.006.
PMID: 40467121DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura Jacox, DMD, PhD
- Organization
- University of North Carolina at Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Laura A Jacox, DMD, PhD, MS
University of North Carolina, Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2021
First Posted
January 13, 2021
Study Start
July 26, 2021
Primary Completion
June 22, 2023
Study Completion
March 4, 2024
Last Updated
August 19, 2024
Results First Posted
August 19, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 1 month following publication up to 1 year
- Access Criteria
- Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an IRB, IEC, or REB as applicable, and an executed data use/sharing agreement with University of North Carolina (UNC).
Deidentified individual data that supports the results will be shared beginning following publication up to 1 year 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.