Animal Assisted Therapy in Pediatric Dentistry
Recruiting · NCT05464888 · Interventional (participants receive a specific treatment) · Lead sponsor: University of North Carolina, Chapel Hill
View the official record on ClinicalTrials.gov →Interventions studied
+Long AAT+Short AATActive control; NO dog
What this trial is about
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.
Who can take part
Age range
4 Years to 8 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- General & Oral Health Center - Chapel Hill, North Carolina, United States