NCT05464888 Animal Assisted Therapy in Pediatric Dentistry
| NCT ID | NCT05464888 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2023-02-02 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 225 participants in total. It began in 2023-02-02 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Laura A Jacox, DMD, PhD, MS
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT05464888 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 8 Years, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05464888 currently recruiting?
Yes, NCT05464888 is actively recruiting participants. Contact the research team at ljacox@live.unc.edu for enrollment information.
Where is the NCT05464888 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT05464888 clinical trial?
NCT05464888 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Laura A Jacox, DMD, PhD, MS at University of North Carolina, Chapel Hill. The trial plans to enroll 225 participants.
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