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Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes

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ClinicalTrials.gov Identifier: NCT02914743
Recruitment Status : Active, not recruiting
First Posted : September 26, 2016
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
Harvard School of Dental Medicine
Information provided by (Responsible Party):
Matthew Tobey, 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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Periodontal Disease Behavioral: Motivational Interviewing Procedure: Dental cleaning Not Applicable

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  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes
Actual Study Start Date : November 2016
Actual Primary Completion Date : October 2, 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

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 Name: 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.



Primary Outcome Measures :
  1. Dental care-seeking behavior [ Time Frame: 12 months ]
    Subject-reported dental visit since hospitalization, assessed at 12 months after intervention.


Secondary Outcome Measures :
  1. Healthcare costs [ Time Frame: Up to 24 months ]
    Subject healthcare expenditures 12 months before and after intervention.

  2. Oral health-related quality of life [ Time Frame: 6 months ]
    Subject-reported oral health-related quality of life assessed at 6 months after intervention.

  3. Change from baseline Hemoglobin A1c at 3 and 6 months [ Time Frame: 6 months ]
    Subject Hemoglobin A1c reading as noted in electronic medical record 3 and 6 months after intervention.


Other Outcome Measures:
  1. Clinician attitude towards the importance of oral health [ Time Frame: 12 months ]
    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.

  2. Clinician attitude towards the value of having a hygienist in the hospital setting [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914743


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Harvard School of Dental Medicine

Additional Information:
Responsible Party: Matthew Tobey, Assistant in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02914743     History of Changes
Other Study ID Numbers: 2016P001460
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Matthew Tobey, Massachusetts General Hospital:
Oral health
Diabetes
Interprofessionalism
Periodontal disease

Additional relevant MeSH terms:
Diabetes Mellitus
Periodontal Diseases
Gingival Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mouth Diseases
Stomatognathic Diseases