Animal Assisted Therapy (AAT)

February 28, 2026 updated by: Rosana Hanke Herrero, University of Puerto Rico

Animal Assisted Therapy as a Behavioral Management Technique During Dental Treatment in Pediatric Patients

The goal of this clinical trial is to evaluate whether treatment assisted by companion dogs, as a behavior management technique during dental treatment in pediatric patients, is effective, in children between 4 and 12 years old.

The main question it aims to answer is:

• Pediatric patients with poor behavior will improve their behavior in the presence of a therapy dog during dental treatments.

Researchers will compare patient behavior with and without the therapy dog to see if behavior during dental treatment improves with dog presence

Participants will complete two dental visits:

  1. First visit: without the therapy dog
  2. Second visit: with the therapy dog present In both visits, the child will receive the same dental treatment required in their treatment plan.

A faculty member will evaluate the child's behavior with and without the therapy dog. Parents or guardians will be asked to complete a sociodemographic questionnaire and a perception survey regarding dental treatment with or without the therapy dog.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
    • PR
      • San Juan, PR, Puerto Rico, 00936
        • University of Puerto Rico - School of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with ages between 4-12 years old
  • Patients who presents history of uncooperativeness during dental treatments and fear/anxiety in the dental setting, according to the parents.
  • Patients must have at least two quadrants of dental interventions of similar complexity available

Exclusion Criteria:

  • Children will be excluded if immunocompromised.
  • Children with a had a medical history of allergies and/or phobias to dogs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With a therapy dog
The second dental treatment visit, in the presence of a therapy dog. The Frankel scale will be used by an external evaluator not the dental operator performing the dental treatment.
Other: animal assisted therapy
Presence of a therapy dog during the dental treatment procedure visit
No Intervention: Without a therapy dog
The first dental treatment visit without the presence of a therapy dog, following general treatment procedure guidelines. The Frankel scale will be used by an external evaluator (not the dental operator) performing the dental treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frankl Scale
Time Frame: through study completion, an average of 1 year

Frankl Scale

  1. --) Definitely negative. Refusal of treatment, forceful crying, fearfulness, or any other overt evidence of extreme negativism.
  2. -) Negative. Reluctance to accept treatment, uncooperative, some evidence of negative attitude but no pronounced (sullen, withdrawn)
  3. +) Positive. Acceptance of treatment, cautious behavior at times, willingness to comply with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively.
  4. -) Definitely positive. Good rapport with the dentist, interest in the dental procedure, laughter and enjoyment.

A Frankl behavior scale (FBR) scale will be recorded during the anesthetic procedure and during the operative/surgical procedure.

Two dental visits of 1 hour each will be scheduled to perform dental treatments of similar complexity. One visit without a dog and a second visit with a therapy dog. The Frankl scale will be done by an external evaluator, not the dental operator performing the dental treatment.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Puerto Rico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2023

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 28, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2310153977

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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