Animal Assisted Therapy in Pediatric Dentistry

Anxiety Clinical Trial

— AAT  

Official title:

Animal Assisted Therapy's Effects on Young Dental Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464888
• Other study ID #: 22-1454
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: February 2027

Study information

• Verified date: April 2024
• 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: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety

Intervention

Behavioral:
• +Short AAT
Interaction with therapy dog prior to dental exam, cleaning, and simulated radiographs.
• +Long AAT
Interaction with therapy dog throughout dental exam, cleaning, and simulated radiographs.
• Active control; NO dog
Color dog picture for 3 minutes prior to dental exam, cleaning, and simulated radiographs.

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 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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.