Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes

Not Applicable

Completed

• Conditions: Type II Diabetes; Periodontal Disease
• Interventions: Behavioral: Motivational Interviewing; Procedure: Dental cleaning

• Registration Number: NCT02914743
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Study Start: 2016-11
• Primary Completion: 2017-10-02
• Study Completion: 2018-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dental Cleaning and MI Arm	Motivational Interviewing	Subjects in this arm will receive a dental cleaning by the hygienist as well as a motivational interviewing (MI) session to explore the subject's motivations to pursue oral health treatment.
Dental Cleaning and MI Arm	Dental cleaning	Subjects in this arm will receive a dental cleaning by the hygienist as well as a motivational interviewing (MI) session to explore the subject's motivations to pursue oral health treatment.
MI only Arm	Motivational Interviewing	Subjects in this arm will not receive a dental cleaning but the hygienist will provide a motivational interviewing (MI) session to explore the subject's motivations to pursue oral health treatment.

Primary Outcome Measures

Name	Time	Method
Dental care-seeking behavior	12 months	Subject-reported dental visit since hospitalization, assessed at 12 months after intervention.

Secondary Outcome Measures

Name	Time	Method
Healthcare costs	Up to 24 months	Subject healthcare expenditures 12 months before and after intervention.
Oral health-related quality of life	6 months	Subject-reported oral health-related quality of life assessed at 6 months after intervention.
Change from baseline Hemoglobin A1c at 3 and 6 months	6 months	Subject Hemoglobin A1c reading as noted in electronic medical record 3 and 6 months after intervention.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States