Animal Assisted Therapy in Pediatric Dentistry

NCT ID: NCT05464888

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-02

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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+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.

Group Type EXPERIMENTAL

+Short AAT

Intervention Type BEHAVIORAL

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

+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.

Group Type EXPERIMENTAL

+Long AAT

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Active control; NO dog

Intervention Type BEHAVIORAL

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

Interventions

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+Short AAT

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

Intervention Type BEHAVIORAL

+Long AAT

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

Intervention Type BEHAVIORAL

Active control; NO dog

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura A Jacox, DMD, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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General & Oral Health Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Laura A Jacox, DMD, PhD, MS

Role: CONTACT

919-537-3424

S.T. Phillips, BSDH

Role: CONTACT

919-537-3422

Facility Contacts

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S.T. Phillips, BSDH

Role: primary

919-537-3422

References

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Kapov G, Linton K, Gatewood C, Liu C, Strauman T, Hodges E, Graves C, Sawicki C, Wu D, Divaris K, Jacox LA. Effects of animal-assisted therapy on dental anxiety, behavior, and perceptions in young pediatric patients: a blinded randomized controlled trial. Trials. 2025 Aug 7;26(1):279. doi: 10.1186/s13063-025-08970-z.

Reference Type DERIVED
PMID: 40775655 (View on PubMed)

Other Identifiers

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22-1454

Identifier Type: -

Identifier Source: org_study_id

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