Animal Assisted Therapy in Dentistry

Anxiety Clinical Trial

— ATT  

Official title:

Animal Assisted Therapy's Effects on Orthodontic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04708028
• Other study ID #: 19-1911
• Status: Recruiting
• Start date: July 26, 2021
• Est. completion date: February 2026

Study information

• Verified date: January 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Laura A jacox, DMD, PhD, Ms
• Phone: 919-537-3424
• Email: ljacox[@]live.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety

Locations

Country	Name	City	State
United States	General & Oral Health Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.