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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| animal assisted therapy | Other | Presence of a therapy dog during the dental treatment procedure visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frankl Scale | Frankl Scale
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. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Puerto Rico - School of Dental Medicine | San Juan | PR | 00936 | Puerto Rico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36208050 | Background | 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. | |
| 38501910 | Background | Garrocho-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. |
| Label | URL |
|---|---|
| Wong-Baker FACES Foundation. Wong-Baker FACES Pain Rating Scale. Wong-Baker FACES Foundation, 2016. | View source |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D056447 | Animal Assisted Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| 37621045 | Background | Guram 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. |
| 30908775 | Background | Prado 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. |
| 38671571 | Background | Kamatham 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. |
| 37997233 | Background | Pinheiro 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. |
| 31370328 | Background | Cruz-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. |
| 40604606 | Background | Khogeer 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. |
| 36259429 | Background | Gussgard 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. |
| 40467121 | Background | Massouda 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. |
| 40775655 | Background | Kapov 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. |
| 33344678 | Background | Sahebalam 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. |
| 11119784 | Background | Odendaal JS. Animal-assisted therapy - magic or medicine? J Psychosom Res. 2000 Oct;49(4):275-80. doi: 10.1016/s0022-3999(00)00183-5. |
| Background | American 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 |
| 29970636 | Background | 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. |
| Background | Cajares C, Rutledge C, Haney T. Animal Assisted Therapy in a Special Needs Dental Practice: An Interprofessional Model for Anxiety Reduction. Journal of Intellectual Disability- Diagnosis and Treatment, 2016; 4:25-28. |
| 33662243 | Background | Charowski M, Wells MH, Dormois L, Fernandez JA, Scarbecz M, Maclin M. A Randomized Controlled Pilot Study Examining Effects of Animal Assisted Therapy in Children Undergoing Sealant Placement. Pediatr Dent. 2021 Jan 15;43(1):10-16. |
| 33245525 | Background | Thakkar TK, Naik SN, Dixit UB. 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. Eur Arch Paediatr Dent. 2021 Jun;22(3):459-467. doi: 10.1007/s40368-020-00583-1. Epub 2020 Nov 27. |
| Background | Nalini B, Kumar C. Animal-assisted therapy as a potential tool for management of dental anxiety in children: A questionnaire-based cross-sectional study. Journal of Clinical and Diagnostic Research. 2022;16(2):ZC30-ZC34. |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |