Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002489 | U.S. NIH Grant/Contract | View source | |
| K08DE030235 | U.S. NIH Grant/Contract | View source | |
| R03DE032768 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Patients will be consented, enrolled, and randomly assigned to a control group (no dog) or to an experimental group with dog present only before their dental visit for 3 minutes (+ Short AAT) or to an experimental group with dog present throughout their entire visit (+ Long AAT). Control (no dog) patients will have an active control where they color for 3 minutes before their dental exam, cleaning, and simulated radiographs, without a dog present. Biometric data will be collected with a small wireless wrist device (Shimmer 3) which measures heart rate and sweat response (skin galvanic response). Salivary samples will be taken before and after the dental visit to measure salivary cortisol and amylase, as a metric of physiological stress. Finally, a video feed of body movements during the dental visit will be collected for observational coding. Pre-visit and post-visit surveys will be given to all the patients on their experiences regarding pain, anxiety, and perceptions of the dental experience.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| +Short AAT | Experimental | 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. |
|
| +Long AAT | Experimental | 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. |
|
| Active control; NO dog | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| +Short AAT | Behavioral | Interaction with therapy dog prior to dental exam, cleaning, and simulated radiographs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Heart Rate during Dental Exam | Beats per minute during dental exam. Heart rate measured using wrist-worn Shimmer heart rate tracking device. | During dental exam, approximately 2- 5 minutes. |
| Mean Heart Rate during Dental Cleaning | Beats per minute during dental cleaning. Heart rate measured using wrist-worn Shimmer heart rate tracking device. | During dental cleaning, approximately 2- 5 minutes. |
| Mean Heart Rate during Dental Radiograph Simulation | Beats per minute during dental radiograph simulation. Heart rate measured using wrist-worn Shimmer heart rate tracking device. | During dental radiograph simulation, approximately 2- 5 minutes. |
| Salivary Cortisol during Dental Exam | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level. | During dental exam, approximately 1-2 minutes. |
| Salivary Cortisol during Dental Cleaning | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level. | During dental cleaning, approximately 1-2 minutes. |
| Salivary Cortisol during Dental Radiograph Simulation | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level. |
Not provided
Not provided
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
Exclusion Criteria: Subjects presenting with any of the following will not be included in the study:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura A Jacox, DMD, PhD, MS | Contact | 919-537-3424 | ljacox@live.unc.edu | |
| S.T. Phillips, BSDH | Contact | 919-537-3422 | sherrill_phillips@unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Laura A Jacox, DMD, PhD, MS | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General & Oral Health Center | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40775655 | Derived | 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. |
Not provided
Not provided
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Not provided
beginning 9 to 36 months following publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| +Long AAT | Behavioral | Interaction with therapy dog throughout dental exam, cleaning, and simulated radiographs. |
|
| Active control; NO dog | Behavioral | Color dog picture for 3 minutes prior to dental exam, cleaning, and simulated radiographs. |
|
| During dental radiograph simulation, approximately 1-2 minutes. |
| Salivary Amylase during Dental Exam | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level. | During dental exam, approximately 1-2 minutes. |
| Salivary Amylase during Dental Cleaning | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level. | During dental cleaning, approximately 1-2 minutes. |
| Salivary Amylase during Dental Radiograph Simulation | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level. | During dental radiograph simulation, approximately 1-2 minutes. |