Animal Assisted Therapy for Anxiety in Pediatric Dentistry

(AAT Trial)

Overseen By S.T. Phillips, BSDH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Non-English speakers, Dental pain, Dog allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how therapy dogs might reduce anxiety in children during dental visits. Researchers will measure stress levels in children aged 4-8 during a dental exam, cleaning, and pretend X-rays. Participants will either interact with a therapy dog for short or long periods (Animal Assisted Therapy, AAT) or have no dog present (Active control; NO dog). Children who haven't had a dental check-up in the last three months and aren't afraid of dogs may be suitable candidates. The goal is to determine if spending time with a dog can make dental visits less stressful for kids.

As an unphased trial, this study provides a unique opportunity to contribute to understanding how therapy dogs can improve children's dental experiences.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using therapy dogs in dental settings is safe and promising. Studies indicate that Animal Assisted Therapy (AAT) reduces anxiety and improves children's behavior during dental visits. Although few studies focus specifically on dentistry, available evidence suggests that children receive AAT well and experience no negative effects. Specially trained therapy dogs interact with kids, helping manage stress and create a positive dental experience. Overall, AAT appears to be a safe way to help children feel more comfortable during dental exams. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how animal-assisted therapy (AAT) with dogs might ease anxiety in young children visiting the dentist. Most treatments for dental anxiety in children involve behavioral therapy or pharmacological options like sedation. However, AAT offers a unique, non-pharmacological approach by allowing children to interact with dogs, which could make dental visits less stressful and more enjoyable. By examining different durations of interaction—either briefly before the exam or throughout the entire visit—the trial aims to determine the best method for reducing anxiety, potentially paving the way for a more engaging and calming dental experience for kids.

What evidence suggests that this trial's treatments could be effective for reducing anxiety in pediatric dentistry?

This trial will compare different approaches to managing anxiety in pediatric dentistry. Research has shown that Animal Assisted Therapy (AAT), which some participants in this trial will receive, can help reduce anxiety in dental settings. Specifically, studies have found that spending time with a therapy dog can lessen pain and anxiety for children during dental visits. Evidence supports that therapy dogs help calm kids, making dental appointments less stressful. Reviews of research highlight AAT's ability to lower anxiety levels in children and teens in various places, including dental offices. Overall, AAT seems promising as a way to ease anxiety and improve the dental experience for young patients. ^{1 4 5 6 7}

Who Is on the Research Team?

Laura A Jacox, DMD, PhD, MS

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Stable physical health, decided at the discretion of the study coordinator and PI

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

I understand and can follow the study's requirements.

Exclusion Criteria

Children who are scared or have had a bad experience with dogs, according to what their parents or they themselves have said.

I am between 4 and 8 years old.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a dental exam, cleaning, and simulated radiographs with or without a therapy dog present. Biometric data and salivary samples are collected.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for stress levels through salivary cortisol and amylase measurements, and heart rate monitoring during the dental procedures.

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active control; NO dog
• Long AAT
• Short AAT

Trial Overview 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.

How Is the Trial Designed?

Group I: +Short AAT Experimental Treatment 1 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 AAT Experimental Treatment 1 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 dog Active Control 1 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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

The study identifies four main categories of potential risks associated with having therapy dogs in dental clinics, including zoonotic pathogens, allergens, adverse animal behavior, and dangers from high activity in a crowded environment.

Despite these risks, the study concludes that they can be effectively managed through awareness and adherence to best practices by dental staff and dog handlers, ensuring a safe environment for both patients and the therapy dog.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dog-assisted therapy in the dental clinic: Part A-Hazards and assessment of potential risks to the health and safety of humans. Gussgard, AM., Weese, JS., Hensten, A., et al.[2023]

A survey of pediatric dentists revealed that 92% believe animal-assisted therapy (AAT) could enhance patient comfort during dental visits, with 67% expecting a moderate to strong improvement.

Despite the positive outlook, concerns about hygiene and liability were significant, with 26% of respondents citing these as major reservations regarding the implementation of AAT in their practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations for Utilizationof Animal-Assisted Therapy in Pediatric Dentistry Practice. Guram, JS., Williams, DS., Marshall, JL.[2023]

In a study involving 20 children undergoing dental treatment, dog-assisted therapy (AAT) significantly reduced heart rates, indicating lower anxiety levels during procedures compared to a control group that did not receive AAT.

While the control group experienced increased anxiety before and after treatment, the AAT group maintained stable anxiety levels, suggesting that AAT could be an effective method for managing anxiety in pediatric dental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dog-assisted therapy for control of anxiety in pediatric dentistry. Pinheiro, SL., Silva, C., Luiz, L., et al.[2023]

In a study involving 102 children aged 5 to 10 undergoing simple dental procedures, the presence of a therapy dog significantly reduced dental anxiety, as measured by pulse rate and anxiety rating scales (p < 0.001).

Animal-assisted therapy not only helps in managing anxiety during dental visits but also shows promise for long-term behavior management and is well-accepted by both children and their parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of dental anxiety in children between 5 and 10 years of age in the presence of a therapy dog: a randomized controlled clinical study. Thakkar, TK., Naik, SN., Dixit, UB.[2021]

A study involving 16 anxious children aged 6 to 12 showed that the presence of a certified therapy dog during dental examinations significantly improved patient compliance and satisfaction, with all participants completing their visits successfully.

Salivary cortisol levels, an indicator of stress, decreased more in the presence of the therapy dog (30% reduction) compared to when the dog was absent (20% reduction), suggesting that therapy dogs can help reduce anxiety in pediatric dental patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoral clinical examinations of pediatric patients with anticipatory anxiety and situational fear facilitated by therapy dog assistance: A pilot RCT. Gussgard, AM., Carlstedt, K., Meirik, M.[2023]

A systematic review of three studies involving 146 children found no significant evidence that animal-assisted therapy (AAT) reduces anxiety during dental treatments, as the anxiety levels were similar whether AAT was present or not.

The studies had a high risk of bias, particularly in randomization and outcome measurement, indicating a need for more rigorous research with larger sample sizes to better assess the efficacy of AAT in reducing anxiety in children during dental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does use of animal therapy during dental care help to reduce anxiety in children and adolescents? A systematic review. Ribeiro, CDPV., Alves, JB., Kominami, PA., et al.[2023]

A study involving 20 children aged 4-11 years demonstrated that a 15-minute exposure to animal-assisted activities in a dental waiting area significantly reduced anxiety levels before dental procedures.

The findings suggest that pet therapy can be an effective method for managing anxiety in pediatric dental patients, contributing to a more positive dental experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A bite out of anxiety: Evaluation of animal-assisted activity on anxiety in children attending a pediatric dental outpatient unit. Nammalwar, RB., Rangeeth, P.[2022]

Citations

1. essentdent.org essentdent.org/index.php/pub/article/download/103/102/38

Animal-Assisted Therapy in Dentistry: A Review The main results indicate that AAT is an effective method for controlling anxi- ety in dental settings, but further investigations and studies ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38671571/

Effectiveness of Animal-Assisted Activity on Pain ... AAA involving a dog led to a reduction in the pain experienced by children undergoing LA administration, subsequently decreasing anxiety.

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08970-z

Effects of animal-assisted therapy on dental anxiety, behavior ... To identify optimal outcome measures for evaluating AAT in pediatric dental contexts, a randomized controlled trial protocol was developed.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11722555/

Effects of Animal-Assisted Therapy for Anxiety Reduction in ... This systematic review aimed to comprehensively assess the evidence regarding the effectiveness of AAT in reducing anxiety among children and adolescents.

5. aaofoundation.net aaofoundation.net/ResourceFiles/pdf/cass-and-rapolla-raa-2021-final-report-9-220eb6.pdf

800.424.2841, #546 Fax Animal-assisted activity. (AAA) is widely used in medicine to reduce anxiety and pain, with promise in dentistry. However, dentistry has been ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40775655/

Effects of animal-assisted therapy on dental anxiety, behavior ... Discussion: This study will provide information on optimal outcome measures to evaluate the impact of AAT on dental anxiety and behavior in ...

7. reporter.nih.gov reporter.nih.gov/project-details/10649010

Project Details - NIH RePORTER The objective of this study is to evaluate whether AAT alleviates stress and improves perceptions during pediatric dental care. We hypothesize that AAT ...