Clinical trial NCT02914743: Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes
Official title: Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type II Diabetes
Periodontal Disease
Keywords: Oral health
Diabetes
Interprofessionalism
Periodontal disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Harvard School of Dental Medicine
First posted: 2016-09-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dental care-seeking behavior
timeFrame: 12 months
Secondary outcomes:
measure: Healthcare costs
timeFrame: Up to 24 months
measure: Oral health-related quality of life
timeFrame: 6 months
measure: Change from baseline Hemoglobin A1c at 3 and 6 months
timeFrame: 6 months
Other outcomes:
measure: Clinician attitude towards the importance of oral health
timeFrame: 12 months
measure: Clinician attitude towards the value of having a hygienist in the hospital setting
timeFrame: 12 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: