Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Disease; Type II Diabetes
• Intervention / Treatment: Behavioral: Motivational Interviewing; Procedure: Dental cleaning

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dental Cleaning and MI Arm; 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.	Behavioral: Motivational 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.; Procedure: Dental cleaning; This procedure will involve the removal of plaque and supragingival and subgingival calculus from the surfaces of the teeth.; Other Names: Dental prophylaxis
Experimental: MI only Arm; 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.	Behavioral: Motivational 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.
No Intervention: Control Arm; Subjects in this arm of the study will not receive any oral health intervention while hospitalized. A medical record review will be completed, and patients will be contacted via telephone at 3, 6, and 12 months post-hospitalization to assess their oral health-related quality of life and oral health care-seeking behaviors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental care-seeking behavior	Subject-reported dental visit since hospitalization, assessed at 12 months after intervention.	12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician attitude towards the importance of oral health	Clinician 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.	12 months
Clinician attitude towards the value of having a hygienist in the hospital setting	Clinician 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.	12 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Harvard School of Dental Medicine

Publications and helpful links

Helpful Links

• Announcement of grant funding

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): October 2, 2017
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimate): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes; Oral health; Periodontal disease; Interprofessionalism
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Stomatognathic Diseases; Mouth Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Periodontal Diseases
• Other Study ID Numbers: 2016P001460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO