Dental Anxiety in ChildrenNCT07798141
Feasibility of a Modified Dental Comfort Position for Pediatric Patients Receiving Dental Exams
A study testing Modified Bottom-to-Bottom Comfort Position in people with Dental Anxiety in Children and Feasibility Studies, run by Children's Hospital Colorado at 1 site in United States.
Trial summary
The goal of this study is to learn if a modified bottom-to-bottom comfort position is a feasible alternative to the traditional knee-to-knee position during dental hygiene examinations for patients aged 12 months to 5 years. Read more about this study
- Who is it for?
- Ages 12 months to 5 years
- Conditions the study is for
- Dental Anxiety in Children, Feasibility Studies, Comfort
- What is being tested?
- Modified Bottom-to-Bottom Comfort Position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Apr 2027
- Phase
- Interventional
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 12 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 12 months to 5 years
- Children attending the CHCO Health Pavilion Dental Clinic for a dental hygiene examination or cleaning visit
- Children accompanied by a parent or legal guardian
Who cannot join
- Children requiring sedation for their dental hygiene visit
- Children and families' primary language is not English or Spanish
- Children requiring medical immobilization (MI) for their hygiene visit
- Dental provider is unwilling to utilize modified bottom-to-bottom positioning
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital Colorado
Denver, Colorado, 80045
Anna Scott, BA, 720-777-2455, anna.scott2@childrenscolorado.org
Kendall Malkin, MS
About this study
Official title: Exploring the Feasibility of a Dental Comfort Position Led by Certified Child Life Specialists and Dental Providers
The goal of this study is to learn if a modified bottom-to-bottom comfort position is a feasible alternative to the traditional knee-to-knee position during dental hygiene examinations for patients aged 12 months to 5 years. In the modified position, the patient sits in their caregiver's lap and reclines their head on the dental chair, allowing for both parental contact and dental provider access to the patient's mouth. This study will also examine the modified position's impact on the patient's distress and cooperation during the exam, parental satisfaction, and provider perception. The main questions are:
Is the modified comfort position a safe and feasible alternative for young children undergoing dental hygiene exams? How does the modified comfort position impact patient completion rate and dental exam duration? How does the modified comfort position impact patient distress and cooperation, parental satisfaction, and provider acceptability?
Read more
Participants will:
Utilize the modified comfort position with the guidance of a Certified Child Life Specialist.
Undergo a routine dental hygiene exam. Answer survey questions about parental satisfaction and patient psychological and developmental diagnoses.
Dental providers will answer survey questions about acceptability and feasibility.
- Conditions
- Dental Anxiety in Children, Feasibility Studies, Comfort
- Being tested
- Modified Bottom-to-Bottom Comfort Position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Bottom-to-Bottom Comfort PositionOther
Patients will sit on their caregiver's lap, facing their caregiver. Patients will recline between their caregiver's legs, so their head rests on the dental chair. Caregivers can hold their child's hands and limit the movement of their child's legs with their forearms. The dental provider can access the child's mouth without needing the child's head to rest in their lap.
| Study group | Role | What they receive |
|---|---|---|
| Modified Dental Comfort Position | Experimental | Patients and caregivers will utilize a modified bottom-to-bottom comfort position with the guidance of a certified Child Life Specialist during a routine dental hygiene exam. Receives: Other: Modified Bottom-to-Bottom Comfort Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate
A five-item measure that tracks patient completion of steps within a dental hygiene exam. Trained research staff members will observe the dental exam and record the patient's completion of each examination step as: completed, attempted but not completed, patient refused, provider didn't attempt due to behavior, and N/A.
Measured: Approximately 30 minutes after starting the dental exam.
Session duration
Total time (in minutes) the child remained in the modified comfort position during the dental examination.
Measured: Approximately 30 minutes after starting the dental exam.
Secondary outcomes (6)
Frankl Behavior Rating Scale
Provider-rated child cooperation during the dental examination, categorized via the Frankl scale classification system from 1 (definitely negative) to 4 (definitely positive).
Measured: Approximately 30 minutes after starting the dental exam.
FLACC (Face, Legs, Activity, Cry, Consolability) Scale
5-item measures to assess the frequency and intensity of observed distress-related behaviors during the dental examination. A trained research staff member will observe the exam and record each item on a scale from 0 (normal, content, relaxed, etc.) to 2 (kicking, rigid, crying, etc.).
Measured: Approximately 15 minutes after starting the dental exam.
Parent Satisfaction
Four-item measure to assess parental satisfaction with the care their child received during their visit. Parents will rate each item on a four-point Likert-like scale ranging from poor to excellent.
Measured: Approximately 30 minutes after starting the dental exam.
Acceptability of Intervention Measure (AIM)
Four-item 5-point Likert scales assessing parental acceptability of the modified comfort hold position.
Measured: Approximately 30 minutes after starting the dental exam.
Feasibility of Intervention Measure (FIM)
Four-item 5-point Likert scales assessing parental feasibility of the modified comfort hold position.
Measured: Approximately 30 minutes after starting the dental exam.
Provider Feedback and Acceptability
Provider-reported acceptability, appropriateness, and perceived feasibility of the modified comfort position
Measured: Approximately 30 minutes after starting the dental exam.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Anxiety in ChildrenStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Colorado
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kendall Malkin, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798141
- Sponsor's protocol ID
- 26-1273
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No