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
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.
80 studies on the registry are indexed under Stomatognathic Diseases; 14 are open to participants now.
This study's planned enrollment of 2,927 is above the median of 60 across 59 interventional studies indexed under Stomatognathic Diseases.
Browse Stomatognathic Diseases studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in Arm A will receive paper handouts with general oral health and aSDoH resources
Behavioral: General information provision
Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources.
Behavioral: Geographic information provision
Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.
Behavioral: Geographic information provision · Behavioral: Navigational assistance
Patients will receive information with general oral health and aSDoH resources.
Patients will receive information with geographically-proximate oral health and aSDoH resources based on a directory created by the study team.
Patients will receive phone-based navigational assistance from the study navigator.
Linkage to oral health care
binary, completion of a dental appointment or not
Time frame: Within 12 months of randomization
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
Repeat visits for oral health problems
binary, any return visit or not
Time frame: Within 12 months of randomization
Rate of linkage to oral health care at the neighborhood level
continuous rate, ranges from 0-100
Time frame: 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)
Time frame: Within 12 months of randomization
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
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, Informed consent form
Time frame: Data will be made available as soon as possible or at the time of associated publication, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
Started Aug 2023 (actual). Primary completion is estimated for Feb 2028, 53 months after the start.
Of 33 non-industry interventional studies with no phase under Stomatognathic Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 28. This study's planned 53 months is above that.
Counting every sponsor, half of 37 studies reached it within 15 months; a quarter within 11 and three quarters within 28.
Stomatognathic Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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