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NCT Number: NCT07798141

Feasibility of a Modified Dental Comfort Position for Pediatric Patients Receiving Dental Exams

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?

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.

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Key information

Conditions

Dental Anxiety in Children Comfort Feasibility Studies

Age range

12 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Denver, Colorado, 80045, United States

Location contact

Anna Scott, BA

CONTACT

[email protected]

720-777-2455

Kendall Malkin, MS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Modified Bottom-to-Bottom Comfort Position

Other

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.

Primary outcomes

  1. Completion Rate

    Time frame: Approximately 30 minutes after starting the dental exam.

    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.

  2. Session duration

    Time frame: Approximately 30 minutes after starting the dental exam.

    Total time (in minutes) the child remained in the modified comfort position during the dental examination.

Secondary outcomes

  1. Frankl Behavior Rating Scale

    Time frame: Approximately 30 minutes after starting the dental exam.

    Provider-rated child cooperation during the dental examination, categorized via the Frankl scale classification system from 1 (definitely negative) to 4 (definitely positive).

  2. FLACC (Face, Legs, Activity, Cry, Consolability) Scale

    Time frame: Approximately 15 minutes after starting the dental exam.

    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.).

  3. Parent Satisfaction

    Time frame: Approximately 30 minutes after starting the dental exam.

    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.

  4. Acceptability of Intervention Measure (AIM)

    Time frame: Approximately 30 minutes after starting the dental exam.

    Four-item 5-point Likert scales assessing parental acceptability of the modified comfort hold position.

  5. Feasibility of Intervention Measure (FIM)

    Time frame: Approximately 30 minutes after starting the dental exam.

    Four-item 5-point Likert scales assessing parental feasibility of the modified comfort hold position.

  6. Provider Feedback and Acceptability

    Time frame: Approximately 30 minutes after starting the dental exam.

    Provider-reported acceptability, appropriateness, and perceived feasibility of the modified comfort position

Sponsors and collaborators

Lead sponsor

Children's Hospital Colorado

Other

Registry information

Official study title

Exploring the Feasibility of a Dental Comfort Position Led by Certified Child Life Specialists and Dental Providers

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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