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Completed

NCT Number: NCT04708028

Animal Assisted Therapy in Dentistry

A cross-sectional prospective study measuring physiologic biometrics and perceptions of stress during a dental procedure with or without a therapy dog present.

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General & Oral Health Center

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dog Therapy

Other

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.

Primary outcomes

  1. Mean Salivary Amylase Levels Throughout Dental Visit

    Time frame: 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.

  2. Mean Salivary Cortisol Levels Throughout Dental Visit

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Official study title

Animal Assisted Therapy's Effects on Dental Patients

Acronym: AAT

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 13, 2021
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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