Dental Fear and AnxietyAATNCT07448714
Animal Assisted Therapy
A study testing animal assisted therapy in people with Dental Fear and Anxiety and Animal Assisted Therapy, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
The goal of this clinical trial is to evaluate whether treatment assisted by companion dogs, as a behavior management technique during dental treatment in pediatric patients, is effective, in children between 4 and 12 years old. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Dental Fear and Anxiety, Animal Assisted Therapy, Dental Treatment
- What is being tested?
- animal assisted therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 13 Dec 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with ages between 4-12 years old
- Patients who presents history of uncooperativeness during dental treatments and fear/anxiety in the dental setting, according to the parents.
- Patients must have at least two quadrants of dental interventions of similar complexity available
Who cannot join
- Children will be excluded if immunocompromised.
- Children with a had a medical history of allergies and/or phobias to dogs.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
University of Puerto Rico - School of Dental Medicine
San Juan, PR, 00936
About this study
Official title: Animal Assisted Therapy as a Behavioral Management Technique During Dental Treatment in Pediatric Patients
The goal of this clinical trial is to evaluate whether treatment assisted by companion dogs, as a behavior management technique during dental treatment in pediatric patients, is effective, in children between 4 and 12 years old.
The main question it aims to answer is:
Read more
- Pediatric patients with poor behavior will improve their behavior in the presence of a therapy dog during dental treatments.
Researchers will compare patient behavior with and without the therapy dog to see if behavior during dental treatment improves with dog presence
Participants will complete two dental visits:
- First visit: without the therapy dog
- Second visit: with the therapy dog present In both visits, the child will receive the same dental treatment required in their treatment plan.
A faculty member will evaluate the child's behavior with and without the therapy dog. Parents or guardians will be asked to complete a sociodemographic questionnaire and a perception survey regarding dental treatment with or without the therapy dog.
- Being tested
- animal assisted therapy
- Keywords
- Animal Assisted Therapy, behavior management, dental fear and anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
animal assisted therapyOther
Presence of a therapy dog during the dental treatment procedure visit
| Study group | Role | What they receive |
|---|---|---|
| With a therapy dog | Experimental | The second dental treatment visit, in the presence of a therapy dog. The Frankel scale will be used by an external evaluator not the dental operator performing the dental treatment. Receives: Other: animal assisted therapy |
| Without a therapy dog | No intervention | The first dental treatment visit without the presence of a therapy dog, following general treatment procedure guidelines. The Frankel scale will be used by an external evaluator (not the dental operator) performing the dental treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frankl Scale
Frankl Scale
- --) Definitely negative. Refusal of treatment, forceful crying, fearfulness, or any other overt evidence of extreme negativism.
- -) Negative. Reluctance to accept treatment, uncooperative, some evidence of negative attitude but no pronounced (sullen, withdrawn)
- +) Positive. Acceptance of treatment, cautious behavior at times, willingness to comply with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively.
- -) Definitely positive. Good rapport with the dentist, interest in the dental procedure, laughter and enjoyment.
A Frankl behavior scale (FBR) scale will be recorded during the anesthetic procedure and during the operative/surgical procedure.
Two dental visits of 1 hour each will be scheduled to perform dental treatments of similar complexity. One visit without a dog and a second visit with a therapy dog. The Frankl scale will be done by an external evaluator, not the dental operator performing the dental treatment.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start13 Dec 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Dental Fear and AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosana Hanke Herrero, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448714
- Sponsor's protocol ID
- 2310153977
- Acronym
- AAT
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ribeiro CDPV, Alves JB, Kominami PA, Takeshita EM, Bezerra ACB, Massignan C. Does use of animal therapy during dental care help to reduce anxiety in children and adolescents? A systematic review. Int J Paediatr Dent. 2023 Mar;33(2):181-195. doi: 10.1111/ipd.13033. Epub 2022 Nov 10.
PubMed 36208050Garrocho-Rangel A, Rosales-Berber M, Rios-Mendez D, Flores-Velazquez J, Trejo-Herbert D, Pozos-Guillen F, Pozos-Guillen A. Dog-Assisted Therapy (DAT) for the management of anxiety during paediatric dental care. A scoping review. Eur J Paediatr Dent. 2024 Jun 3;25(2):120-125. doi: 10.23804/ejpd.2024.2001. Epub 2024 Mar 1.
PubMed 38501910Guram JS, Williams DS, Marshall JL. Considerations for Utilizationof Animal-Assisted Therapy in Pediatric Dentistry Practice. J Dent Child (Chic). 2023 May 15;90(2):70-75.
PubMed 37621045Prado IM, Carcavalli L, Abreu LG, Serra-Negra JM, Paiva SM, Martins CC. Use of distraction techniques for the management of anxiety and fear in paediatric dental practice: A systematic review of randomized controlled trials. Int J Paediatr Dent. 2019 Sep;29(5):650-668. doi: 10.1111/ipd.12499. Epub 2019 Apr 25.
PubMed 30908775Kamatham R, Anchala K, Kanagaluru C, Vinnakota DN. Effectiveness of Animal-Assisted Activity on Pain Perception and Anxiety of Children Undergoing Intraoral Local Anesthetic Administration. J Dent Child (Chic). 2024 Jan 15;91(1):31-37.
PubMed 38671571Pinheiro SL, Silva C, Luiz L, Silva N, Fonseca R, Velasquez T, Grandizoli DR. Dog-assisted therapy for control of anxiety in pediatric dentistry. J Clin Pediatr Dent. 2023 Nov;47(6):38-43. doi: 10.22514/jocpd.2023.080. Epub 2023 Nov 3.
PubMed 37997233Cruz-Fierro N, Vanegas-Farfano M, Gonzalez-Ramirez MT. Dog-Assisted Therapy and Dental Anxiety: A Pilot Study. Animals (Basel). 2019 Jul 31;9(8):512. doi: 10.3390/ani9080512.
PubMed 31370328Khogeer LN, Sabbagh HJ, Felemban OM, Farsi NM. Puppet play therapy in emergency pediatric dental clinic. A randomized clinical trial. BMC Pediatr. 2025 Jul 2;25(1):503. doi: 10.1186/s12887-025-05849-5.
PubMed 40604606Gussgard AM, Carlstedt K, Meirik M. Intraoral clinical examinations of pediatric patients with anticipatory anxiety and situational fear facilitated by therapy dog assistance: A pilot RCT. Clin Exp Dent Res. 2023 Feb;9(1):122-133. doi: 10.1002/cre2.679. Epub 2022 Oct 19.
PubMed 36259429Massouda 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.
PubMed 40467121Kapov G, Linton K, Gatewood C, Liu C, Strauman T, Hodges E, Graves C, Sawicki C, Wu D, Divaris K, Jacox LA. Effects of animal-assisted therapy on dental anxiety, behavior, and perceptions in young pediatric patients: a blinded randomized controlled trial. Trials. 2025 Aug 7;26(1):279. doi: 10.1186/s13063-025-08970-z.
PubMed 40775655Sahebalam R, Rafieinezhad R, Boskabad M. Comparison of the Efficacy of Jilo Animation Approach versus Conventional Tell-Show-Do (TSD) Technique on Cooperation and Anxiety Levels of Children during Dental Practice: A Randomized Controlled Clinical Trials. J Dent (Shiraz). 2020 Dec;21(4):284-291. doi: 10.30476/dentjods.2020.81897.1001.
PubMed 33344678Odendaal JS. Animal-assisted therapy - magic or medicine? J Psychosom Res. 2000 Oct;49(4):275-80. doi: 10.1016/s0022-3999(00)00183-5.
PubMed 11119784American Academy of Pediatric Dentistry. Behavior guidance for the pediatric dental patient. The Reference Manual of Pediatric Dentistry. Chicago, Ill,: American Academy of Pediatric Dentistry; 2022:321-39
Nammalwar RB, Rangeeth P. A bite out of anxiety: Evaluation of animal-assisted activity on anxiety in children attending a pediatric dental outpatient unit. J Indian Soc Pedod Prev Dent. 2018 Apr-Jun;36(2):181-184. doi: 10.4103/JISPPD.JISPPD_54_18.
PubMed 29970636
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animal Assisted Therapy as a Behavioral Management Technique During Dental Treatment in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07448714
- Acronym / sponsor ID
- AAT / 2310153977
- Keywords
- Animal Assisted Therapy, behavior management, dental fear and anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether treatment assisted by companion dogs, as a behavior management technique during dental treatment in pediatric patients, is effective, in children between 4 and 12 years old.
The main question it aims to answer is:
- Pediatric patients with poor behavior will improve their behavior in the presence of a therapy dog during dental treatments.
Researchers will compare patient behavior with and without the therapy dog to see if behavior during dental treatment improves with dog presence
Participants will complete two dental visits:
- First visit: without the therapy dog
- Second visit: with the therapy dog present In both visits, the child will receive the same dental treatment required in their treatment plan.
A faculty member will evaluate the child's behavior with and without the therapy dog. Parents or guardians will be asked to complete a sociodemographic questionnaire and a perception survey regarding dental treatment with or without the therapy dog.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With a therapy dog | Experimental | Other: animal assisted therapyThe second dental treatment visit, in the presence of a therapy dog. The Frankel scale will be used by an external evaluator not the dental operator performing the dental treatment. |
| Without a therapy dog | No intervention | –The first dental treatment visit without the presence of a therapy dog, following general treatment procedure guidelines. The Frankel scale will be used by an external evaluator (not the dental operator) performing the dental treatment. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with ages between 4-12 years old
- Patients who presents history of uncooperativeness during dental treatments and fear/anxiety in the dental setting, according to the parents.
- Patients must have at least two quadrants of dental interventions of similar complexity available
Key exclusion criteria (2 listed)
- Children will be excluded if immunocompromised.
- Children with a had a medical history of allergies and/or phobias to dogs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| animal assisted therapyPresence of a therapy dog during the dental treatment procedure visit | Other | With a therapy dog |
Primary outcome
Frankl Scale
Time frame: through study completion, an average of 1 year
Frankl Scale 1. --) Definitely negative. Refusal of treatment, forceful crying, fearfulness, or any other overt evidence of extreme negativism. 2. -) Negative. Reluctance to accept treatment, uncooperative, some evidence of negative attitude but no pronounced (sullen, withdrawn) 3. +) Positive. Acceptance of treatment, cautious behavior at times, willingness to comply with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively. 4. -) Definitely positive. Good rapport with the dentist, interest in the dental procedure, laughter and enjoyment. A Frankl behavior scale (FBR) scale will be recorded during the anesthetic procedure and during the operative/surgical procedure. Two dental visits of 1 hour each will be scheduled to perform dental treatments of similar complexity. One visit without a dog and a second visit with a therapy dog. The Frankl scale will be done by an external evaluator, not the dental operator performing the dental treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 36208050Ribeiro CDPV, Alves JB, Kominami PA, Takeshita EM, Bezerra ACB, Massignan C. Does use of animal therapy during dental care help to reduce anxiety in children and adolescents? A systematic review. Int J Paediatr Dent. 2023 Mar;33(2):181-195. doi: 10.1111/ipd.13033. Epub 2022 Nov 10.
- Background: PubMed 38501910Garrocho-Rangel A, Rosales-Berber M, Rios-Mendez D, Flores-Velazquez J, Trejo-Herbert D, Pozos-Guillen F, Pozos-Guillen A. Dog-Assisted Therapy (DAT) for the management of anxiety during paediatric dental care. A scoping review. Eur J Paediatr Dent. 2024 Jun 3;25(2):120-125. doi: 10.23804/ejpd.2024.2001. Epub 2024 Mar 1.
- Background: PubMed 37621045Guram JS, Williams DS, Marshall JL. Considerations for Utilizationof Animal-Assisted Therapy in Pediatric Dentistry Practice. J Dent Child (Chic). 2023 May 15;90(2):70-75.
- Background: PubMed 30908775Prado IM, Carcavalli L, Abreu LG, Serra-Negra JM, Paiva SM, Martins CC. Use of distraction techniques for the management of anxiety and fear in paediatric dental practice: A systematic review of randomized controlled trials. Int J Paediatr Dent. 2019 Sep;29(5):650-668. doi: 10.1111/ipd.12499. Epub 2019 Apr 25.
- Background: PubMed 38671571Kamatham R, Anchala K, Kanagaluru C, Vinnakota DN. Effectiveness of Animal-Assisted Activity on Pain Perception and Anxiety of Children Undergoing Intraoral Local Anesthetic Administration. J Dent Child (Chic). 2024 Jan 15;91(1):31-37.
- Background: PubMed 37997233Pinheiro SL, Silva C, Luiz L, Silva N, Fonseca R, Velasquez T, Grandizoli DR. Dog-assisted therapy for control of anxiety in pediatric dentistry. J Clin Pediatr Dent. 2023 Nov;47(6):38-43. doi: 10.22514/jocpd.2023.080. Epub 2023 Nov 3.
- Background: PubMed 31370328Cruz-Fierro N, Vanegas-Farfano M, Gonzalez-Ramirez MT. Dog-Assisted Therapy and Dental Anxiety: A Pilot Study. Animals (Basel). 2019 Jul 31;9(8):512. doi: 10.3390/ani9080512.
- Background: PubMed 40604606Khogeer LN, Sabbagh HJ, Felemban OM, Farsi NM. Puppet play therapy in emergency pediatric dental clinic. A randomized clinical trial. BMC Pediatr. 2025 Jul 2;25(1):503. doi: 10.1186/s12887-025-05849-5.
- Background: PubMed 36259429Gussgard AM, Carlstedt K, Meirik M. Intraoral clinical examinations of pediatric patients with anticipatory anxiety and situational fear facilitated by therapy dog assistance: A pilot RCT. Clin Exp Dent Res. 2023 Feb;9(1):122-133. doi: 10.1002/cre2.679. Epub 2022 Oct 19.
- Background: PubMed 40467121Massouda 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.
- Background: PubMed 40775655Kapov G, Linton K, Gatewood C, Liu C, Strauman T, Hodges E, Graves C, Sawicki C, Wu D, Divaris K, Jacox LA. Effects of animal-assisted therapy on dental anxiety, behavior, and perceptions in young pediatric patients: a blinded randomized controlled trial. Trials. 2025 Aug 7;26(1):279. doi: 10.1186/s13063-025-08970-z.
- Background: PubMed 33344678Sahebalam R, Rafieinezhad R, Boskabad M. Comparison of the Efficacy of Jilo Animation Approach versus Conventional Tell-Show-Do (TSD) Technique on Cooperation and Anxiety Levels of Children during Dental Practice: A Randomized Controlled Clinical Trials. J Dent (Shiraz). 2020 Dec;21(4):284-291. doi: 10.30476/dentjods.2020.81897.1001.
- Wong-Baker FACES Foundation. Wong-Baker FACES Pain Rating Scale. Wong-Baker FACES Foundation, 2016.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing animal assisted therapy in people with Dental Fear and Anxiety and Animal Assisted Therapy, run by University of Puerto Rico at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frankl Scale (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07448714, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.