Dental DiseasesNCT05688982
MOLAR: Mapping Oral Health and Local Area Resources
A study testing General information provision, Geographic information provision and Navigational assistance in people with Dental Diseases, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Dental Diseases
- What is being tested?
- General information provision, Geographic information provision and Navigational assistance
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,927 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2023to 22 Feb 2028
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
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
Massachusetts General Hospital
Boston, Massachusetts, 02114
Margaret Samuels-Kalow, MD MSHP
About this study
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.
- Conditions
- Dental Diseases
- Being tested
- General information provision, Geographic information provision, Navigational assistance
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General information provisionBehavioural
Patients will receive information with general oral health and aSDoH resources.
Geographic information provisionBehavioural
Patients will receive information with geographically-proximate oral health and aSDoH resources based on a directory created by the study team.
Navigational assistanceBehavioural
Patients will receive phone-based navigational assistance from the study navigator.
| Study group | Role | What they receive |
|---|---|---|
| A--general information | Other | Patients in Arm A will receive paper handouts with general oral health and aSDoH resources Receives: Behavioral: General information provision |
| B--geographic information | Other | Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources. Receives: Behavioral: Geographic information provision |
| C--geographic information and navigational assistance | Other | Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance. Receives: Behavioral: Geographic information provision; Behavioral: Navigational assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to oral health care
binary, completion of a dental appointment or not
Measured: Within 12 months of randomization
Secondary outcomes (5)
Time to completion of dental appointment at the individual level
continuous, days from randomization to completion of dental appointment
Measured: Within 12 months of randomization
Repeat visits for oral health problems
binary, any return visit or not
Measured: Within 12 months of randomization
Rate of linkage to oral health care at the neighborhood level
continuous rate, ranges from 0-100
Measured: Within 12 months of randomization
Oral health quality of life
Total score on OHIP-14 (continuous, ranges from 0-56) or OHIP-5 (0-20)
Measured: Within 12 months of randomization
Return visits
Number of return visits to the ED, outpatient visits, inpatient admissions, and ICU admissions (each continuous).
Measured: Within 12 months of initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start25 Aug 2023
- Primary completion22 Feb 2028 (estimated)
- Study completion22 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,927 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Margaret Samuels-Kalow, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688982
- Sponsor's protocol ID
- 2022P003224
- Other IDs
- UH3DE031920
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOLAR: Mapping Oral Health and Local Area Resources
- ClinicalTrials.gov ID
- NCT05688982
- Acronym / sponsor ID
- 2022P003224
- Conditions
- Dental Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,927 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 22 Feb 2028 (estimated)
- Study completion
- 22 Feb 2028 (estimated)
- First posted
- 18 Jan 2023 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A--general information | Other | Behavioral: General information provisionPatients in Arm A will receive paper handouts with general oral health and aSDoH resources |
| B--geographic information | Other | Behavioral: Geographic information provisionPatients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources. |
| C--geographic information and navigational assistance | Other | Behavioral: Geographic information provision, Behavioral: Navigational assistancePatients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| General information provisionPatients will receive information with general oral health and aSDoH resources. | Behavioural | A--general information |
| Geographic information provisionPatients will receive information with geographically-proximate oral health and aSDoH resources based on a directory created by the study team. | Behavioural | B--geographic information, C--geographic information and navigational assistance |
| Navigational assistancePatients will receive phone-based navigational assistance from the study navigator. | Behavioural | C--geographic information and navigational assistance |
Primary outcome
Linkage to oral health care
Time frame: Within 12 months of randomization
binary, completion of a dental appointment or not
5 secondary outcomes
Time to completion of dental appointment at the individual level
Time frame: Within 12 months of randomization
Repeat visits for oral health problems
Time frame: Within 12 months of randomization
Rate of linkage to oral health care at the neighborhood level
Time frame: Within 12 months of randomization
Oral health quality of life
Time frame: Within 12 months of randomization
Return visits
Time frame: Within 12 months of initial 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 13 Aug 2026.
- Derived from this study: PubMed 38072485Simon 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.
- Individual participant dataSharing planned: 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General information provision, Geographic information provision and Navigational assistance in people with Dental Diseases, run by Massachusetts General Hospital 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 9 inclusion and 4 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 13 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 Margaret Samuels-Kalow (617-726-8340, msamuels-kalow@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to oral health care (time frame: Within 12 months of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05688982, which also lists 1 linked publication.
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 13 Aug 2026.