N/A
N=40
Animal Assisted Therapy in Dentistry
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT04708028 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Mean Salivary Amylase Levels Throughout Dental Visit — 150.82; 166.70; 127.77; 145.39 U/mL — p=0.379
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dog Therapy (Other)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Salivary Amylase Levels Throughout Dental Visit |
150.82; 166.70; 127.77; 145.39; 97.78; 175.11 | 0.379 |
| PRIMARY Mean Salivary Cortisol Levels Throughout Dental Visit |
0.185; 0.155; 0.153; 0.154; 0.223; 0.133 | 0.410 |
Summary
A cross-sectional prospective study measuring physiologic biometrics and perceptions of stress during a dental procedure with or without a therapy dog present.
Eligibility Criteria
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
- 7-17 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
Exclusion Criteria Subjects presenting with any of the following will not be included in the study:
- 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).
Data sourced from ClinicalTrials.gov (NCT04708028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.