Periodontal Disease Clinical Trial
Official title:
Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes
NCT number | NCT02914743 |
Other study ID # | 2016P001460 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | October 2018 |
Verified date | March 2019 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Harvard School of Dental Medicine |
United States,
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 |
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