Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes

NCT02914743 | Completed

• 1 other identifier: 2016P001460
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Type II Diabetes; Periodontal Disease

Keywords

Oral health; Diabetes; Interprofessionalism; Periodontal disease

Outcome Measures

Primary Outcomes (1)

• Dental care-seeking behavior

  Subject-reported dental visit since hospitalization, assessed at 12 months after intervention.

  12 months

Secondary Outcomes (3)

• Healthcare costs

  Up to 24 months

• Oral health-related quality of life

  6 months

• Change from baseline Hemoglobin A1c at 3 and 6 months

  6 months

Other Outcomes (2)

• Clinician attitude towards the importance of oral health

  12 months

• Clinician attitude towards the value of having a hygienist in the hospital setting

  12 months

Study Arms (3)

Dental Cleaning and MI Arm

EXPERIMENTAL

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; Procedure: Dental cleaning

MI only Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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.

Interventions

Motivational Interviewing BEHAVIORAL

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.

Dental Cleaning and MI Arm; MI only Arm

Dental cleaning PROCEDURE

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

Also known as: Dental prophylaxis

Dental Cleaning and MI Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of cardiac conditions for which antibiotic prophylaxis is indicated prior to dental treatment per American Dental Association/American Heart Association guidelines:51
• Prosthetic cardiac valve or prosthetic material used for cardiac valve repair
• Previous infective endocarditis
• 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
• Anticoagulated with International Normalized Ratio\>2.5
• History of prosthetic joint replacement in the last two years
• Medical team declines enrollment
• 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
• Edentulous

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Harvard School of Dental Medicine: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• Announcement of grant funding

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periodontal Diseases; Diabetes Mellitus

Interventions

Motivational Interviewing; Dental Prophylaxis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Periodontics; Dentistry; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Medicine

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 26, 2016
• Study Start: November 1, 2016
• Primary Completion: October 2, 2017
• Study Completion: October 1, 2018
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)