Animal Assisted Therapy in Pediatric Dentistry (AAT)

Animal Assisted Therapy's Effects on Young Dental Patients

A prospective randomized trial measuring physiologic biometrics and perceptions of stress during a pediatric dental exam, cleaning, and simulated radiographs with or without a therapy dog present.

Study Overview

• Status: Recruiting
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: +Short AAT; Behavioral: +Long AAT; Behavioral: Active control; NO dog

Detailed Description

Patients will be consented, enrolled, and randomly assigned to a control group (no dog) or to an experimental group with dog present only before their dental visit for 3 minutes (+ Short AAT) or to an experimental group with dog present throughout their entire visit (+ Long AAT). Control (no dog) patients will have an active control where they color for 3 minutes before their dental exam, cleaning, and simulated radiographs, without a dog present. Biometric data will be collected with a small wireless wrist device (Shimmer 3) which measures heart rate and sweat response (skin galvanic response). Salivary samples will be taken before and after the dental visit to measure salivary cortisol and amylase, as a metric of physiological stress. Finally, a video feed of body movements during the dental visit will be collected for observational coding. Pre-visit and post-visit surveys will be given to all the patients on their experiences regarding pain, anxiety, and perceptions of the dental experience.

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

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: 919-537-3422; 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, BSDH; Phone Number: 919-537-3422; Email: sherrill_phillips@unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:

• 4-8 years of age
• English speaking
• Qualifies for a dental exam and prophylaxis (cleaning) by having not received a dental prophylaxis or oral exam in the past 3 months
• Stable physical health, decided at the discretion of the study coordinator and PI
• Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based on research site personnel's assessment
• Evidence of a personally signed and dated informed assent form from the child and legal guardian's consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all of their questions have been answered

Exclusion Criteria: Subjects presenting with any of the following will not be included in the study:

• Patients <4yo and >8yo
• Non-English speakers
• Patients unwilling to assent/participate or parental/guardian consent was not given
• Self-report or parental report of patient suffering current dental pain
• Known allergies or significant adverse reactions following exposure to dogs or the use of oral hygiene products (toothpastes, mouth rinses), and all ingredients in prophy paste
• Children who are afraid of dogs or had a prior negative experience with dogs as reported by the parent or child
• Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial
• Developmental/cognitive disability such that patient cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: +Short AAT; Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 experimental patients who will be interacting with the dog prior to their oral exam.	Behavioral: +Short AAT; Interaction with therapy dog prior to dental exam, cleaning, and simulated radiographs.
Experimental: +Long AAT; Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 experimental patients who will be interacting with the dog throughout their entire visit.	Behavioral: +Long AAT; Interaction with therapy dog throughout dental exam, cleaning, and simulated radiographs.
Active Comparator: Active control; NO dog; Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 control patients who will not be interacting with the dog during their visit and will color a dog picture for 3 minutes instead.	Behavioral: Active control; NO dog; Color dog picture for 3 minutes prior to dental exam, cleaning, and simulated radiographs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Heart Rate during Dental Exam	Beats per minute during dental exam. Heart rate measured using wrist-worn Shimmer heart rate tracking device.	During dental exam, approximately 2- 5 minutes.
Mean Heart Rate during Dental Cleaning	Beats per minute during dental cleaning. Heart rate measured using wrist-worn Shimmer heart rate tracking device.	During dental cleaning, approximately 2- 5 minutes.
Mean Heart Rate during Dental Radiograph Simulation	Beats per minute during dental radiograph simulation. Heart rate measured using wrist-worn Shimmer heart rate tracking device.	During dental radiograph simulation, approximately 2- 5 minutes.
Salivary Cortisol during Dental Exam	To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.	During dental exam, approximately 1-2 minutes.
Salivary Cortisol during Dental Cleaning	To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.	During dental cleaning, approximately 1-2 minutes.
Salivary Cortisol during Dental Radiograph Simulation	To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.	During dental radiograph simulation, approximately 1-2 minutes.
Salivary Amylase during Dental Exam	To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.	During dental exam, approximately 1-2 minutes.
Salivary Amylase during Dental Cleaning	To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.	During dental cleaning, approximately 1-2 minutes.
Salivary Amylase during Dental Radiograph Simulation	To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.	During dental radiograph simulation, 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): February 2, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22-1454

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 9 to 36 months following publication 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: beginning 9 to 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

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