Animal Assisted Therapy in Dentistry

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Other: Dog Therapy

• Registration Number: NCT04708028
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Patients will be consented, enrolled, and assigned to a control group (no dog) or to an experimental group (dog). The patient assigned to the experimental group will be exposed to the therapy animal prior to the dental appointment. Pre-dental procedure and post-dental procedure surveys will be given to all the subjects asking the same questions. Biometric data will be collected by measuring heart rates of the patient/subject during the dental appointment with a Shimmer or Polar device.

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-13
• Study Start: 2021-07-26
• Primary Completion: 2023-06-22
• Status Verified: 2024-03
• Study Completion: 2024-03-04
• Results First Submitted: 2024-03-22
• Results First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Results First Posted: 2024-08-19
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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).

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dog Therapy	Dog Therapy	Introduced to a therapy dog and allowed to pet the dog for up to 2 minutes (timed) prior to the dental procedure.

Primary Outcome Measures

Name	Time	Method
Mean Salivary Cortisol Levels Throughout Dental Visit	Up to end of dental visit; a total average between 60 to 90 minutes	To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.
Mean Salivary Amylase Levels Throughout Dental Visit	Up to end of dental visit; a total average between 60 to 90 minutes	To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.

Trial Locations

Locations (1)

General & Oral Health Center; 🇺🇸 Chapel Hill, North Carolina, United States