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Animal Assisted Therapy for Anxiety in Pediatric Dentistry (AAT Trial)

N/A
Recruiting
Led By Laura A Jacox, DMD, PhD, MS
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
4-8 years of age
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during dental radiograph simulation, approximately 2- 5 minutes.
Awards & highlights

AAT Trial Summary

This trial found that having a therapy dog present during a pediatric dental exam, cleaning, and simulated radiographs led to lower perceptions of stress.

Who is the study for?
This trial is for children aged 4-8 who speak English and haven't had a dental exam or cleaning in the last 3 months. They should be healthy, able to follow study procedures, and have their guardian's consent. Kids with severe health issues, allergies to dogs or oral hygiene products, fear of dogs, or those not willing to participate are excluded.Check my eligibility
What is being tested?
The study tests how therapy dogs might affect stress levels during dental visits for kids. It compares longer sessions with a dog (Long AAT), shorter ones (Short AAT), and control visits without a dog by measuring stress through physical signs and personal feelings.See study design
What are the potential side effects?
There may not be direct side effects from the interventions since they involve interaction with therapy dogs rather than medication. However, potential indirect effects could include allergic reactions to the dog for those sensitive.

AAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 4 and 8 years old.

AAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during dental exam, approximately 2- 5 minutes.
This trial's timeline: 3 weeks for screening, Varies for treatment, and during dental exam, approximately 2- 5 minutes. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Heart Rate during Dental Cleaning
Mean Heart Rate during Dental Exam
Mean Heart Rate during Dental Radiograph Simulation
+6 more

AAT Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: +Short AATExperimental Treatment1 Intervention
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 II: +Long AATExperimental Treatment1 Intervention
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 III: Active control; NO dogActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,817 Total Patients Enrolled
11 Trials studying Anxiety
3,000 Patients Enrolled for Anxiety
Laura A Jacox, DMD, PhD, MSPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Anxiety
120 Patients Enrolled for Anxiety

Media Library

Active control; NO dog Clinical Trial Eligibility Overview. Trial Name: NCT05464888 — N/A
Anxiety Research Study Groups: Active control; NO dog, +Short AAT, +Long AAT
Anxiety Clinical Trial 2023: Active control; NO dog Highlights & Side Effects. Trial Name: NCT05464888 — N/A
Active control; NO dog 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464888 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment accessible to those aged 65 and below?

"This trial is open to children aged between 4 and 8 years of age."

Answered by AI

Are any individuals currently enrolling in this research program?

"As disclosed on clinicaltrials.gov, this medical trial is not actively recruiting subjects at the moment; it was first posted on November 1st 2022 and edited for the last time in October 11th 2022. Although no longer open to enrollment, there are currently 375 other trials looking for participants."

Answered by AI

Are there any qualifications that would allow me to partake in this medical research?

"The trial seeks 225 participants aged 4-8 who suffer from anxiety. Applicants are required to have not received a dental prophylaxis or oral exam in the past 3 months, be English speaking and of stable physical health, understand and follow the requirements of the study, provide assent (for minors) as well as consent documents signed by legal guardians indicating that all pertinent aspects of the trial have been discussed."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
General & Oral Health Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~150 spots leftby Feb 2027