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RecruitingNCT05688982Updated Aug 13, 2026

MOLAR: Mapping Oral Health and Local Area Resources

An interventional study of General information provision and Geographic information provision in Dental Diseases, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
2,927
Allocation
Randomized
Ages
1 Year and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Dental Diseases
03

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,927 participants (estimated)

Study arms

  • Other
    A--general information

    Patients in Arm A will receive paper handouts with general oral health and aSDoH resources

    Behavioral: General information provision

  • Other
    B--geographic information

    Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources.

    Behavioral: Geographic information provision

  • Other
    C--geographic information and navigational assistance

    Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.

    Behavioral: Geographic information provision · Behavioral: Navigational assistance

Interventions

  • BehavioralGeneral information provision

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

  • BehavioralGeographic information provision

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

  • BehavioralNavigational assistance

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

05

What researchers measure

Primary outcomes

  1. Linkage to oral health care

    binary, completion of a dental appointment or not

    Time frame: Within 12 months of randomization

Secondary outcomes

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

    continuous, days from randomization to completion of dental appointment

    Time frame: Within 12 months of randomization

  2. Repeat visits for oral health problems

    binary, any return visit or not

    Time frame: Within 12 months of randomization

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

    continuous rate, ranges from 0-100

    Time frame: Within 12 months of randomization

  4. Oral health quality of life

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

    Time frame: Within 12 months of randomization

  5. Return visits

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

    Time frame: Within 12 months of initial visit

06

Study locations

1 of 1 sites recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    • Margaret Samuels-Kalow, MD MSHP · Contact
    Recruiting
07

References and documents

Publications

  • Simon L, Marsh R, Sanchez LD, Camargo C, Donoff B, Cardenas V, Manning W, Loo S, Cash RE, Samuels-Kalow ME. Mapping Oral health and Local Area Resources (MOLAR): protocol for a randomised controlled trial connecting emergency department patients with social and dental resources. BMJ Open. 2023 Dec 10;13(12):e078157. doi: 10.1136/bmjopen-2023-078157. PubMed 38072485 ↗

Individual participant data

Plan to share: Yes — Due to the sensitive nature of the database (including information about potential stigmatizing factors including social risk and need), access to scientific data will be controlled and provided under a restricted data contract to users who demonstrate a valid research need and meet conditions of use. Scientific Data derived from humans will be protected through de-identification, removal of information that may be used to infer the identity of individuals and shared under controlled-access conditions as required by institutional policy.

Supporting information: Study protocol, Icf

08

Registry details

Key details

Study ID
NCT05688982
Lead sponsor
Massachusetts General Hospital
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Responsible party
Margaret Samuels-Kalow (Associate Professor, Massachusetts General Hospital) — Principal investigator
First posted
Jan 18, 2023
Start date
Aug 25, 2023
Primary completion
Feb 22, 2028 (estimated)
Completion
Feb 22, 2028 (estimated)
Last update
Aug 13, 2026

Study contacts

Margaret Samuels-Kalow
Contact
msamuels-kalow@partners.org
617-726-8340

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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