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NCT Number: NCT05688982

MOLAR: Mapping Oral Health and Local Area Resources

The goal of this clinical trial is to test the impact of a screening and linkage intervention for adverse social determinants of health (aSDoH) on oral health linkage to care for emergency department patients. Researchers will compare three groups: Patients in Arm A will receive paper handouts with general oral health and aSDoH resources. Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources. Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.

Recruiting

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Key information

Conditions

Dental Diseases Stomatognathic Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Margaret Samuels-Kalow, MD MSHP

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • To be eligible to participate in this study, an individual must meet all of the following criteria:
  • No evidence of lack of capacity to provide verbal informed consent (as documented in the chart).
  • Willing to comply with all study procedures and be available by phone for the duration of the study (as reported by the patient)
  • Unmet oral health needs as ascertained by the Hope Home (adult) or Gazzaz (pediatric) questions
  • Adult (age ≥18 years old) ED patient or pediatric ED patient (>1 year of age) presenting with parent or legal guardian. Parent will be the primary study participant but if age > 7 years, the child will provide assent for medical record review.
  • Ability to communicate in English or Spanish (as reported by the patient)
  • Emergency severity index (ESI) 2-5 (as documented in the electronic medical record)
  • Residence within catchment area of 3-hospital region (defined by MGB home hospital catchment area) at initial enrollment (as reported by the patient)
  • Working phone number

Exclusion criteria

  • Patients on involuntary holds (per electronic medical record review)
  • Presenting from carceral facilities (per electronic medical record review)
  • Presenting for acute mental health care under evaluation for Section 12 (per electronic medical record review)
  • Patients presenting for assistance with intimate partner violence (IPV) or care following sexual assault

Treatment and study plan

General information provision

Behavioral

Patients will receive information with general oral health and aSDoH resources.

Geographic information provision

Behavioral

Patients will receive information with geographically-proximate oral health and aSDoH resources based on a directory created by the study team.

Navigational assistance

Behavioral

Patients will receive phone-based navigational assistance from the study navigator.

Primary outcomes

  1. Linkage to oral health care

    Time frame: Within 12 months of randomization

    binary, completion of a dental appointment or not

Secondary outcomes

  1. Time to completion of dental appointment at the individual level

    Time frame: Within 12 months of randomization

    continuous, days from randomization to completion of dental appointment

  2. Repeat visits for oral health problems

    Time frame: Within 12 months of randomization

    binary, any return visit or not

  3. Rate of linkage to oral health care at the neighborhood level

    Time frame: Within 12 months of randomization

    continuous rate, ranges from 0-100

  4. Oral health quality of life

    Time frame: Within 12 months of randomization

    Total score on OHIP-14 (continuous, ranges from 0-56) or OHIP-5 (0-20)

  5. Return visits

    Time frame: Within 12 months of initial visit

    Number of return visits to the ED, outpatient visits, inpatient admissions, and ICU admissions (each continuous).

Study contacts

Contact information is provided by the study sponsor or research team.

Margaret Samuels-Kalow

CONTACT

[email protected]

617-726-8340

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 18, 2023
Registry last updated
Apr 9, 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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