DesensitizationNCT06620289
Impact of Dental Desensitization Facilitated by a Child Life Specialist Distress and Cooperation
An observational study of Desensitization and Dental Anxiety, run by Children's Hospital Colorado at 1 site in United States.
Trial summary
The aim of this study is to evaluate whether dental desensitization visits facilitated by a Certified Child Life Specialist (CCLS) significantly impact pediatric patients' distress and cooperation levels from the start of desensitization visit(s) to end of the desensitization visit(s), end of desensitization visit to… Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Desensitization, Dental Anxiety, Dental Care
- What is being tested?
- Dental Desensitization Clinic
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2024to 18 May 2026
- Phase
- Observational
- 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 2 to 25 years
- All sexes
- Child, Adult
Study population: Pediatric patients and their parents scheduled in the dental center at Children's Hospital Colorado Health Pavillion referred to a child life specialist-facilitated desensitization clinic will be recruited to the study.
Who may be able to join
- Patients and parents of patients aged 2-25 years who have been referred to the desensitization clinic.
- Patients who meet with a CCLS for dental desensitization.
Who cannot join
- Patients younger than 2 years old and older than 25 years old.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: The Impact of Dental Desensitization Visits Facilitated by a Child Life Specialist on Pediatric Patients' Distress and Cooperation
The aim of this study is to evaluate whether dental desensitization visits facilitated by a Certified Child Life Specialist (CCLS) significantly impact pediatric patients' distress and cooperation levels from the start of desensitization visit(s) to end of the desensitization visit(s), end of desensitization visit to start of subsequent hygiene appointment, and end of hygiene appointment.
- Being tested
- Dental Desensitization Clinic
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Desensitization ClinicBehavioural
The goal of offering desensitization visits is to reduce the dental anxiety and distress of patients and enhance their cooperation during future appointments. The specifics of the desensitization are individualized to meet the unique needs of each patient based on information provided by the parent/caregiver. A standard desensitization visit involves providing the patient the opportunity to sit in the exam chair; touch the toothbrush and rubber prophy cup, mouth mirror, fluoride applicator brush, air-water syringe tip and saliva ejector tip; gain exposure to the dental lights and sounds commonly experienced in the dental visit; practice opening their mouth; and tolerate toothbrush and rubber prophy cup, mirror, explorer, fluoride applicator brush, air-water syringe, and salvia ejector in the mouth. If the child is unable or unwilling to participate, these activities are modeled on the parent or by the CCLS.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frankl Behavioral Rating Scale (FBRS)
The FBRS is widely used in pediatric dentistry to evaluate patient behavior. FBRS consists of four behavior categories ranging from "definitely positive" to "definitely negative," with higher scores indicating more cooperation. The rating is assigned by the treating pediatric provider and recorded in the patient's medical record at the end of the visit. Participants achieve a scored on a scale ranging from 1 (definitely negative) to 4 (definitely positive).
Measured: From enrollment to the end of study at approximately 3 months.
Secondary outcomes (5)
Pre-Visit Parent Survey
Parents/caregivers will be asked to fill out a questionnaire before and after the desensitization visit and after the subsequent hygiene appointment. Questions will relate to previous dental experience, previous visit Sensory Tolerance Checklist and the parent's perception of visit success.
Measured: Before desensitization visit.
Repeated Desensitization Visit - Pre-Desensitization Parent Survey
If a patient requires more than one dental desensitization visit during the study period, the research team will collect data during subsequent desensitization visits. This survey is a modified and shortened version of the "Pre-Visit Parent Survey" and aims to assess if there have been any changes to the child's developmental diagnoses as well as track how many desensitization visits the patient has had.
Measured: Before repeated (if applicable) desensitization visits.
Sensory Tolerance Checklist
Tolerance is operationalized as allowing dental instrument(s) to touch a patient for 1-2 seconds without resisting or exhibiting distress. Three attempts will be made for each step on the checklist before being identified as incomplete. This checklist will be completed by the CCLS and the clinical research coordinator (CRC) for interrater reliability during the desensitization visit.
Measured: From enrollment to the end of study at approximately 3 months.
The Children's Fear Scale (CFS)
Measure fear in children undergoing painful medical procedures. Patients receive a score ranging from 0 (Not scared at all) to 5 (Most scared possible).
Measured: From enrollment to the end of study at approximately 3 months.
Psychosocial Risk Assessment in Pediatrics (PRAP)
The PRAP assesses pediatric patients by evaluating which patients are at risk of experiencing elevated distress during their health care encounters. Children are scored on a cumulative risk score from 0 (low risk) to 24 (high risk). Scores are categorized into low (0-7 points), medium (8-14 points), and high (15-24) risk levels.
Measured: From enrollment to the end of study at approximately 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start26 Aug 2024
- Primary completion18 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DesensitizationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Colorado
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Barta, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620289
- Sponsor's protocol ID
- 24-0196
- Status last verified
- Jun 2026
- First submitted
- 25 Sep 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dental Desensitization Visits Facilitated by a Child Life Specialist on Pediatric Patients' Distress and Cooperation
- ClinicalTrials.gov ID
- NCT06620289
- Acronym / sponsor ID
- 24-0196
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's Hospital ColoradoUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 1 Oct 2024 (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 aim of this study is to evaluate whether dental desensitization visits facilitated by a Certified Child Life Specialist (CCLS) significantly impact pediatric patients' distress and cooperation levels from the start of desensitization visit(s) to end of the desensitization visit(s), end of desensitization visit to start of subsequent hygiene appointment, and end of hygiene appointment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric patients and their parents scheduled in the dental center at Children's Hospital Colorado Health Pavillion referred to a child life specialist-facilitated desensitization clinic will be recruited to the study.
Key inclusion criteria (2 listed)
- Patients and parents of patients aged 2-25 years who have been referred to the desensitization clinic.
- Patients who meet with a CCLS for dental desensitization.
Key exclusion criteria (1 listed)
- Patients younger than 2 years old and older than 25 years old.
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 |
|---|---|---|
| Dental Desensitization ClinicThe goal of offering desensitization visits is to reduce the dental anxiety and distress of patients and enhance their cooperation during future appointments. The specifics of the desensitization are individualized to meet the unique needs of each patient based on information provided by the parent/caregiver. A standard desensitization visit involves providing the patient the opportunity to sit in the exam chair; touch the toothbrush and rubber prophy cup, mouth mirror, fluoride applicator brush, air-water syringe tip and saliva ejector tip; gain exposure to the dental lights and sounds commonly experienced in the dental visit; practice opening their mouth; and tolerate toothbrush and rubber prophy cup, mirror, explorer, fluoride applicator brush, air-water syringe, and salvia ejector in the mouth. If the child is unable or unwilling to participate, these activities are modeled on the parent or by the CCLS. | Behavioural | – |
Primary outcome
Frankl Behavioral Rating Scale (FBRS)
Time frame: From enrollment to the end of study at approximately 3 months.
The FBRS is widely used in pediatric dentistry to evaluate patient behavior. FBRS consists of four behavior categories ranging from "definitely positive" to "definitely negative," with higher scores indicating more cooperation. The rating is assigned by the treating pediatric provider and recorded in the patient's medical record at the end of the visit. Participants achieve a scored on a scale ranging from 1 (definitely negative) to 4 (definitely positive).
5 secondary outcomes
Pre-Visit Parent Survey
Time frame: Before desensitization visit.
Repeated Desensitization Visit - Pre-Desensitization Parent Survey
Time frame: Before repeated (if applicable) desensitization visits.
Sensory Tolerance Checklist
Time frame: From enrollment to the end of study at approximately 3 months.
The Children's Fear Scale (CFS)
Time frame: From enrollment to the end of study at approximately 3 months.
Psychosocial Risk Assessment in Pediatrics (PRAP)
Time frame: From enrollment to the end of study at approximately 3 months.
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 29 Jun 2026.
- Individual participant dataSharing planned: No
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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?
An observational study of Desensitization and Dental Anxiety, run by Children's Hospital Colorado at 1 site in United States.
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 2 inclusion and 1 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 29 Jun 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 United States. 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 Behavioral Rating Scale (FBRS) (time frame: From enrollment to the end of study at approximately 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.