Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes

Periodontal Disease Clinical Trial

Official title:

Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914743
• Other study ID #: 2016P001460
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: October 2018

Study information

• Verified date: March 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2018
• Est. primary completion date: October 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Periodontal Disease
• Periodontal Diseases
• Type II Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Harvard School of Dental Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Dental care-seeking behavior	Subject-reported dental visit since hospitalization, assessed at 12 months after intervention.	12 months
Secondary	Healthcare costs	Subject healthcare expenditures 12 months before and after intervention.	Up to 24 months
Secondary	Oral health-related quality of life	Subject-reported oral health-related quality of life assessed at 6 months after intervention.	6 months
Secondary	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

External Links

•   Announcement of grant funding