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OpenTrials
Completed

NCT Number: NCT07448714

Animal Assisted Therapy

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Puerto Rico - School of Dental Medicine

San Juan, PR, 00936, Puerto Rico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

animal assisted therapy

Other

Presence of a therapy dog during the dental treatment procedure visit

Primary outcomes

  1. Frankl Scale

    Time frame: through study completion, an average of 1 year

    Frankl Scale

    • --) Definitely negative. Refusal of treatment, forceful crying, fearfulness, or any other overt evidence of extreme negativism.
    • -) Negative. Reluctance to accept treatment, uncooperative, some evidence of negative attitude but no pronounced (sullen, withdrawn)
    • +) 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.
    • -) 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.

Sponsors and collaborators

Lead sponsor

University of Puerto Rico

Other

Registry information

Official study title

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

Acronym: AAT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2026
Registry last updated
Mar 4, 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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