Intellectual Disability, VariableNCT06710483
A Pilot Project to Facilitate Dental Care and Reduce Barriers For Youth With Disabilities
A study testing Pre-Dental Telehealth (PDT) in people with Intellectual Disability, Variable, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Intellectual Disability, Variable
- What is being tested?
- Pre-Dental Telehealth (PDT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- None
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, 1 recruiting
- Recruiting
Goldman School of Dental Medicine
Boston, Massachusetts, 02118
Keri Discepolo, DDS MPH, 617-358-6512, kdiscep@bu.edu
About this study
Official title: 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.
- Conditions
- Intellectual Disability, Variable
- Being tested
- Pre-Dental Telehealth (PDT)
- Keywords
- Intellectual and developmental disabilities, Telehealth interview, Pediatric dental care, Pre-Dental Care Telehealth Visit
- Medical subject headings
- Intellectual Disability, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Dental Telehealth (PDT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 1 week of the dental visit
Secondary outcomes (2)
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].
Measured: 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].
Measured: within 1 week of the dental visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start20 Aug 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual Disability, VariableStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Deborah Munroe Noonan Memorial Research Fund
- Responsible party
- Sponsor
- Investigators
- Keri Discepolo, DDS MPH, Principal investigator, Goldman School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710483
- Sponsor's protocol ID
- H-45236
- Other IDs
- 55211805
- Status last verified
- Aug 2026
- First submitted
- 26 Nov 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Telehealth Dental Interviews Facilitate in Person Clinical Visits for Patients With Complex Medical Needs?
- ClinicalTrials.gov ID
- NCT06710483
- Acronym / sponsor ID
- H-45236
- Conditions
- Intellectual Disability, Variable
- Keywords
- Intellectual and developmental disabilities, Telehealth interview, Pediatric dental care, Pre-Dental Care Telehealth Visit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Deborah Munroe Noonan Memorial Research Fund
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Dental Visit Telehealth Interview | Experimental | Behavioral: Pre-Dental Telehealth (PDT)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. |
| 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Pre-Dental Visit Telehealth Interview |
Primary outcome
Number of participants who successfully completed the dental visit goal
Time frame: within 1 week of the dental visit
This will be assessed by reviewing the goal set in the PDT and comparing it to what was done at the dental visit.
2 secondary outcomes
Caregiver satisfaction
Time frame: within 1 week of the dental visit
Dentist satisfaction
Time frame: within 1 week of the dental visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keri Discepolo, DDS MPH principal investigator
Goldman School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Dental Telehealth (PDT) in people with Intellectual Disability, Variable, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rua Milaeh, DDS MPH (617-358-6512, milaeh@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who successfully completed the dental visit goal (time frame: within 1 week of the dental visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.