MOLAR: Mapping Oral Health and Local Area Resources

NCT ID: NCT05688982

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2049 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-25

Study Completion Date

2028-02-22

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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A--general information

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

Group Type OTHER

General information provision

Intervention Type BEHAVIORAL

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

B--geographic information

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

Group Type OTHER

Geographic information provision

Intervention Type BEHAVIORAL

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

C--geographic information and navigational assistance

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

Group Type OTHER

Geographic information provision

Intervention Type BEHAVIORAL

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

Navigational assistance

Intervention Type BEHAVIORAL

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

Interventions

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General information provision

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

Intervention Type BEHAVIORAL

Geographic information provision

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

Intervention Type BEHAVIORAL

Navigational assistance

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Margaret Samuels-Kalow

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Margaret Samuels-Kalow

Role: CONTACT

617-726-8340

Facility Contacts

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Margaret Samuels-Kalow, MD MSHP

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38072485 (View on PubMed)

Other Identifiers

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UH3DE031920

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022P003224

Identifier Type: -

Identifier Source: org_study_id

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