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NCT Number: NCT05464888

Animal Assisted Therapy in Pediatric Dentistry

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General & Oral Health Center

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

S.T. Phillips, BSDH

CONTACT

[email protected]

919-537-3422

About this study

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.

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:

  • 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

Treatment and study plan

+Short AAT

Behavioral

Interaction with therapy dog prior to dental exam, cleaning, and simulated radiographs.

+Long AAT

Behavioral

Interaction with therapy dog throughout dental exam, cleaning, and simulated radiographs.

Active control; NO dog

Behavioral

Color dog picture for 3 minutes prior to dental exam, cleaning, and simulated radiographs.

Primary outcomes

  1. Mean Heart Rate during Dental Exam

    Time frame: During dental exam, approximately 2- 5 minutes.

    Beats per minute during dental exam. Heart rate measured using wrist-worn Shimmer heart rate tracking device.

  2. Mean Heart Rate during Dental Cleaning

    Time frame: During dental cleaning, approximately 2- 5 minutes.

    Beats per minute during dental cleaning. Heart rate measured using wrist-worn Shimmer heart rate tracking device.

  3. Mean Heart Rate during Dental Radiograph Simulation

    Time frame: During dental radiograph simulation, approximately 2- 5 minutes.

    Beats per minute during dental radiograph simulation. Heart rate measured using wrist-worn Shimmer heart rate tracking device.

  4. Salivary Cortisol during Dental Exam

    Time frame: During dental exam, approximately 1-2 minutes.

    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.

  5. Salivary Cortisol during Dental Cleaning

    Time frame: During dental cleaning, approximately 1-2 minutes.

    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.

  6. Salivary Cortisol during Dental Radiograph Simulation

    Time frame: During dental radiograph simulation, approximately 1-2 minutes.

    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.

  7. Salivary Amylase during Dental Exam

    Time frame: During dental exam, approximately 1-2 minutes.

    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.

  8. Salivary Amylase during Dental Cleaning

    Time frame: During dental cleaning, approximately 1-2 minutes.

    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.

  9. Salivary Amylase during Dental Radiograph Simulation

    Time frame: During dental radiograph simulation, approximately 1-2 minutes.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura A Jacox, DMD, PhD, MS

CONTACT

[email protected]

919-537-3424

S.T. Phillips, BSDH

CONTACT

[email protected]

919-537-3422

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Animal Assisted Therapy's Effects on Young Dental Patients

Acronym: AAT

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 19, 2022
Registry last updated
Jun 12, 2026

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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