Animal Assisted Therapy in Dentistry (ATT)

Animal Assisted Therapy's Effects on Orthodontic Patients

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

Study Overview

• Status: Recruiting
• Conditions: Anxiety

Detailed Description

Patients will be consented, enrolled, and randomly 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 Fitbit.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Laura A Jacox, DMD, PhD, MS; Phone Number: 919-537-3424; Email: ljacox@live.unc.edu
• Study Contact Backup: Name: S.T. Phillips, BSDH; Phone Number: 9195373422; Email: sherrill_phillips@unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • General & Oral Health Center
      • Contact: S.T. Phillips; Phone Number: 919-537-3422; Email: sherrill_phillips@unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

120 participants total (60 no therapy dog exposure, 60 with therapy do exposure) recruited from UNC Graduate Pediatric Dental Clinic

1 quadrant of restorative dental procedures requiring a handpiece (could include multiple fillings, sealants and/or stainless-steel crowns) and/or extraction(s) not requiring sedation (no pharmacological sedation) 7-17 years of age any gender or race/ethnicity moderate dental anxiety with a Frankl score of 2-3 No fear of dogs or dog allergies

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; No exposure to the therapy dog.
Dog Therapy; Introduced to a therapy dog and allowed to pet the dog for up to 2 minutes (timed) prior to the dental procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Heart Rate during Dental Injection	Beats per minute during dental injection. Heart rate measured using wrist-worn Shimmer.	During dental injection, approximately 1 minute.
Mean Heart Rate Post-Dental Procedure	Beats per minute after dental procedure. Heart rate measured using wrist-worn Shimmer.	After dental procedure, approximately 1-2 minutes.
Salivary Cortisol during Dental Injection	To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.	During dental injection, approximately 1 minute.
Salivary Cortisol Post-Dental Procedure	To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.	After dental procedure, approximately 1-2 minutes.
Salivary Amylase during Dental Injection	To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.	During dental injection, approximately 1 minute.
Salivary Amylase Post-Dental Procedure	To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.	After dental procedure, approximately 1-2 minutes.

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Laura A Jacox, DMD, PhD, MS, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Anticipated): February 1, 2026
• Study Completion (Anticipated): February 1, 2026

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19-1911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 1 month following publication up to 1 year
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No