Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-07-26
2024-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control
No exposure to the therapy dog.
No interventions assigned to this group
Dog Therapy
Introduced to a therapy dog and allowed to pet the dog for up to 2 minutes (timed) prior to the dental procedure.
Dog Therapy
The intervention is a therapy dog interaction (e.g. petting) for up to 2 minutes before their appointment and first interaction with the doctor. The subject can pet the dog for as long as they like up until the 2 minute mark.
Interventions
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Dog Therapy
The intervention is a therapy dog interaction (e.g. petting) for up to 2 minutes before their appointment and first interaction with the doctor. The subject can pet the dog for as long as they like up until the 2 minute mark.
Eligibility Criteria
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Inclusion Criteria
* Patient undergoing 1 quadrant restorative dental procedure requiring a handpiece (e.g. multiple fillings, sealants and/or stainless-steel crowns) and/or extraction(s)
* History of moderate dental anxiety with a Frankl score of 2-3 based on Epic chart review
Exclusion Criteria
* No history of dental anxiety
* Moderate to severe allergy to dogs
* Previous traumatic experience with a dog and/or self-reported fear of dogs
* Patients who are not receiving dental care requiring a handpiece (for ex, prophylaxis only)
* Patients with severe, documented xerostomia
* Patients receiving sedation (pharmacological and conscious sedation) or general anesthesia
* Patients who will have physical restraints placed during the dental procedure
* Patient scheduled to have sedation or general anesthesia
* Severe acute or chronic medical or psychiatric condition(s) that would interfere with the interpretation of results, and in the judgement of the Investigator, would make the subject inappropriate for entry into the trial
* Patient with developmental/cognitive disability that cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment.
* Inability or unwillingness of individual and legal guardian/representative to give written informed assent (from child) and consent (from adult).
7 Years
17 Years
ALL
Yes
Sponsors
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North Carolina Translational and Clinical Sciences Institute
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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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
Countries
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References
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Massouda J, Ghaltakhchyan N, Judd J, Bocklage C, Selden R, TumSuden O, Nanney E, Lee J, Ginnis J, Strauman T, Sawicki C, Hodges EA, Graves C, Divaris K, Jacox L. Evaluating effects of animal-assisted therapy on pediatric dental care patients: A pilot clinical trial. J Am Dent Assoc. 2025 Jun;156(6):447-457.e14. doi: 10.1016/j.adaj.2025.03.006.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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19-1911
Identifier Type: -
Identifier Source: org_study_id
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