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Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes

Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02914743
Enrollment
90
Registered
2016-09-26
Start date
2016-11-30
Completion date
2018-10-31
Last updated
2019-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetes, Periodontal Disease

Keywords

Oral health, Diabetes, Interprofessionalism, Periodontal disease

Brief summary

The purpose of this research intervention is to assess the oral health status and periodontal health of patients with diabetes hospitalized on a general medicine service, and to assess the effect of providing dental prophylaxis and motivational interviewing to patient health-seeking behaviors and provider attitudes towards oral health, as well as on patient health outcomes.

Detailed description

Almost 20% of all patients admitted to the hospital carry a diagnosis of diabetes. Diabetes and periodontal disease have a bi-directional relationship; people with diabetes are at higher risk of tooth loss and poor oral health may impact nutrition and inflammation. Even among those with access to medical treatment for their diabetes, access to dental care may be challenging. In spite of their higher oral health risk, diabetic adults are less likely than their peers to attend a dental visit annually. While oral hygiene measures for ventilator-dependent patients have become standard of care, the oral health of less critically ill hospitalized patients has been noted to decline over the course of their hospitalization and patients generally do not have access to dental treatment., However, invasive dental treatment (restorations, tooth extraction, and periodontal scaling) has been demonstrated to be safe even for critically ill hospitalized patients. The inpatient setting, where patients are already receiving services from multiple disciplines and patients do not need to travel to see a healthcare provider, presents a unique opportunity to make integrative oral healthcare services accessible to diabetic patients, and to increase oral health knowledge of those health professionals caring for patients on an inpatient medical ward. This study will involve provision of dental prophylaxis (tooth cleaning) as well as motivational interviewing focused on oral health care-seeking behaviors provided by a dental hygienist to patients with a diagnosis of Type II diabetes who are hospitalized on a medicine floor of Massachusetts General Hospital.

Interventions

BEHAVIORALMotivational Interviewing

This intervention will involve a discussion intended to explore subjects' motivations to pursue dental care and empower them to visit a dentist upon release from the hospital.

This procedure will involve the removal of plaque and supragingival and subgingival calculus from the surfaces of the teeth.

Sponsors

Harvard School of Dental Medicine
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient has diagnosis of type 2 diabetes * Patient has a primary care provider of record * Patient is currently admitted to the house staff service of the Department of Medicine at MGH * Patient is ready or nearly ready for discharge, based on the assessment of the patient's medical team.

Exclusion criteria

1. History of cardiac conditions for which antibiotic prophylaxis is indicated prior to dental treatment per American Dental Association/American Heart Association guidelines:51 1. Prosthetic cardiac valve or prosthetic material used for cardiac valve repair 2. Previous infective endocarditis 3. Congenital heart disease (CHD) encompassing: i. Unrepaired cyanotic CHD, including palliative shunts and conduits ii. Completely repaired congenital heart defect with prosthetic material or device, whether placed by surgery or by catheter intervention, during the first six months after the procedure iii. Repaired CHD with residual defects at the site or adjacent to the site of a prosthetic patch or prosthetic device (which inhibit endothelialization) d. Cardiac transplantation recipients who develop cardiac valvulopathy 2. Anticoagulated with International Normalized Ratio\>2.5 3. History of prosthetic joint replacement in the last two years 4. Medical team declines enrollment 5. The patient is unable to participate in the provision of dental prophylaxis due to a medical condition such as altered mental status or altered cognitive status 6. Edentulous

Design outcomes

Primary

MeasureTime frameDescription
Dental care-seeking behavior12 monthsSubject-reported dental visit since hospitalization, assessed at 12 months after intervention.

Secondary

MeasureTime frameDescription
Healthcare costsUp to 24 monthsSubject healthcare expenditures 12 months before and after intervention.
Oral health-related quality of life6 monthsSubject-reported oral health-related quality of life assessed at 6 months after intervention.
Change from baseline Hemoglobin A1c at 3 and 6 months6 monthsSubject Hemoglobin A1c reading as noted in electronic medical record 3 and 6 months after intervention.

Other

MeasureTime frameDescription
Clinician attitude towards the importance of oral health12 monthsClinician attitudes towards the importance of oral health for patient wellbeing before and after working with the study's dental hygienist as measured by a Likert-scale question.
Clinician attitude towards the value of having a hygienist in the hospital setting12 monthsClinician attitudes towards the value of working with a hygienist in the hospital setting before and after working with the study's dental hygienist as measured by a Likert-scale question.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026