Recruiting

Therapy Dog

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT05464888

Conditions

Anxiety

Eligibility Criteria

Sex: All

Age: 4 - 8

Healthy Volunteers: Accepted

Interventions

+Short AAT

+Long AAT

Active control; NO dog

Study Details

Brief 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.

Conditions

Anxiety

Study ID

NCT05464888

Start date

Feb 2, 2023

Status verified date

Jun, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 8

Healthy Volunteers: Accepted

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 Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

+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.

Primary outcome measure

  • Mean Heart Rate during Dental Exam [ Time Frame: During dental exam, approximately 2- 5 minutes. ]
  • Mean Heart Rate during Dental Cleaning [ Time Frame: During dental cleaning, approximately 2- 5 minutes. ]
  • Mean Heart Rate during Dental Radiograph Simulation [ Time Frame: During dental radiograph simulation, approximately 2- 5 minutes. ]
  • Salivary Cortisol during Dental Exam [ Time Frame: During dental exam, approximately 1-2 minutes. ]
  • Salivary Cortisol during Dental Cleaning [ Time Frame: During dental cleaning, approximately 1-2 minutes. ]
  • Salivary Cortisol during Dental Radiograph Simulation [ Time Frame: During dental radiograph simulation, approximately 1-2 minutes. ]
  • Salivary Amylase during Dental Exam [ Time Frame: During dental exam, approximately 1-2 minutes. ]
  • Salivary Amylase during Dental Cleaning [ Time Frame: During dental cleaning, approximately 1-2 minutes. ]
  • Salivary Amylase during Dental Radiograph Simulation [ Time Frame: During dental radiograph simulation, approximately 1-2 minutes. ]

Central Contacts and Locations

Central contacts

Laura A Jacox, DMD, PhD, MS

919-537-3424ljacox@live.unc.edu

S.T. Phillips, BSDH

919-537-3422sherrill_phillips@unc.edu

Locations

General & Oral Health Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

S.T. Phillips, BSDH

919-537-3422sherrill_phillips@unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-06-12.