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

NCT06710483 | Recruiting

• 2 other identifiers: H-4523655211805
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intellectual Disability, Variable

Keywords

Intellectual and developmental disabilities; Telehealth interview; Pediatric dental care; Pre-Dental Care Telehealth Visit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Caregiver satisfaction

  within 1 week of the dental visit

• Dentist satisfaction

  within 1 week of the dental visit

Study Arms (2)

Pre-Dental Visit Telehealth Interview

EXPERIMENTAL

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)

Routine Dental Visit

NO INTERVENTION

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.

Interventions

Pre-Dental Telehealth (PDT) BEHAVIORAL

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.

Pre-Dental Visit Telehealth Interview

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Boston University: lead
• Deborah Munroe Noonan Memorial Research Fund: collaborator

Study Sites (1)

Goldman School of Dental Medicine

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Intellectual Disability; Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Keri Discepolo, DDS MPH

  Goldman School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keri Discepolo, DDS MPH

CONTACT

617-358-6512; kdiscep@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: August 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)