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

NCT07798141 | Not Yet Recruiting

• 1 other identifier: 26-1273
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Anxiety in Children; Feasibility Studies; Comfort

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Approximately 30 minutes after starting the dental exam.

Secondary Outcomes (6)

• Frankl Behavior Rating Scale

  Approximately 30 minutes after starting the dental exam.

• FLACC (Face, Legs, Activity, Cry, Consolability) Scale

  Approximately 15 minutes after starting the dental exam.

• Parent Satisfaction

  Approximately 30 minutes after starting the dental exam.

• Acceptability of Intervention Measure (AIM)

  Approximately 30 minutes after starting the dental exam.

• Feasibility of Intervention Measure (FIM)

  Approximately 30 minutes after starting the dental exam.

Study Arms (1)

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.

Other: Modified Bottom-to-Bottom Comfort Position

Interventions

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.

Modified Dental Comfort Position

Eligibility Criteria

• Age: 12 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Colorado: lead

Study Sites (1)

Children's Hospital Colorado

Denver, Colorado, 80045, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)