A Pilot Project to Facilitate Dental Care and Reduce Barriers For Youth With Disabilities

Do Telehealth Dental Interviews Facilitate in Person Clinical Visits for Patients With Complex Medical Needs?

This randomized clinical trial is an innovative pilot project to determine the acceptance and impact of telehealth visits on youth with intellectual and developmental disabilities (IDD), their caregivers, and dentists. The impact of the telehealth visit will be assessed by: 1) determining if the intervention group was more likely to achieve the set goals and 2) Likert scaled surveys of satisfaction of caregivers and dentists. Qualitative data will be collected to inform improvement on clinical interviews by the dentist.

Study Overview

• Status: Recruiting
• Conditions: Intellectual Disability, Variable
• Intervention / Treatment: Behavioral: Pre-Dental Telehealth (PDT)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rua Milaeh, DDS MPH; Phone Number: 617-358-6512; Email: milaeh@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Goldman School of Dental Medicine
      • Contact: Keri Discepolo, DDS MPH; Phone Number: 617-358-6512; Email: kdiscep@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have an appointment for a routine check up at the Pediatric Clinic or Pediatric Health Center at the Boston University Goldman School of Dental Medicine
• Diagnosis of Intellectual or developmental disability (IDD)
• Have a caregiver who is willing to participate in the study
• Have a dental provider who is willing to participate in the study
• English speaking

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-Dental Visit Telehealth Interview; Participants randomized into this arm will receive a scripted telehealth interview before the scheduled dental visit.The participant's' caregiver and dentist will complete a survey within a week of the dental visit.	Behavioral: Pre-Dental Telehealth (PDT); The PDT will be a scripted telehealth interview 3-7 days before the scheduled dental visit to review medical and dental history, to evaluate the participants' needs for the dental visit, and to set an agreed goal for the dental visit using shared decision making. The goal wlll be one of the following: Goal 1: exam cleaning only, Goal 2: exam and cleaning, Goal 3: exam, radiographs, and cleaning.
No Intervention: Routine Dental Visit; Participants randomized into this arm will receive standard of care dental visit. The participant's' caregiver and dentist will complete a survey within a week of the dental visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who successfully completed the dental visit goal	This will be assessed by reviewing the goal set in the PDT and comparing it to what was done at the dental visit.	within 1 week of the dental visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver satisfaction	This outcome will be assessed by analyzing the 10 Likert scale items from a 13-item investigator developed survey. Each off the 10 items is answered with a 5 response Likert scale [Strongly disagree, Disagree, Neither Disagree nor Agree, Agree, Strongly Agree].	within 1 week of the dental visit
Dentist satisfaction	This outcome will be assessed by analyzing the 10 Likert scale items from a 12-item investigator developed survey. Each off the 10 items is answered with a 5 response Likert scale [Strongly disagree, Disagree, Neither Disagree nor Agree, Agree, Strongly Agree].	within 1 week of the dental visit

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Deborah Munroe Noonan Memorial Research Fund
• Investigators: Principal Investigator: Keri Discepolo, DDS MPH, Goldman School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Intellectual and developmental disabilities; Telehealth interview; Pediatric dental care; Pre-Dental Care Telehealth Visit
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Developmental Disabilities; Intellectual Disability
• Other Study ID Numbers: H-45236; 55211805 (Other Grant/Funding Number: Deborah Munroe Noonan Memorial Research Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No