Type II DiabetesNCT02914743
Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes
A study testing Motivational Interviewing and Dental cleaning in people with Type II Diabetes and Periodontal Disease, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes, Periodontal Disease
- What is being tested?
- Motivational Interviewing and Dental cleaning
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Type II Diabetes, Periodontal Disease
- Being tested
- Motivational Interviewing, Dental cleaning
- Keywords
- Oral health, Diabetes, Interprofessionalism, Periodontal disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Periodontal Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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 cleaningProcedure or surgery
Also called Dental prophylaxis
This procedure will involve the removal of plaque and supragingival and subgingival calculus from the surfaces of the teeth.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental care-seeking behavior
Subject-reported dental visit since hospitalization, assessed at 12 months after intervention.
Measured: 12 months
Secondary outcomes (3)
Healthcare costs
Subject healthcare expenditures 12 months before and after intervention.
Measured: Up to 24 months
Oral health-related quality of life
Subject-reported oral health-related quality of life assessed at 6 months after intervention.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startNov 2016
- Primary completion2 Oct 2017
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Dental Medicine
- Responsible party
- Principal investigator, Matthew Tobey, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914743
- Sponsor's protocol ID
- 2016P001460
- Status last verified
- Mar 2019
- First submitted
- 20 Sep 2016
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes
- ClinicalTrials.gov ID
- NCT02914743
- Acronym / sponsor ID
- 2016P001460
- Conditions
- Type II Diabetes, Periodontal Disease
- Keywords
- Oral health, Diabetes, Interprofessionalism, Periodontal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Harvard School of Dental Medicine
- Study start
- Nov 2016 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dental Cleaning and MI Arm | Experimental | Behavioral: Motivational Interviewing, Procedure: Dental cleaningSubjects 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. |
| MI only Arm | Experimental | Behavioral: Motivational InterviewingSubjects 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- History of cardiac conditions for which antibiotic prophylaxis is indicated prior to dental treatment per American Dental Association/American Heart Association guidelines:51
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingThis 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. | Behavioural | Dental Cleaning and MI Arm, MI only Arm |
| Dental cleaningAlso: Dental prophylaxisThis procedure will involve the removal of plaque and supragingival and subgingival calculus from the surfaces of the teeth. | Procedure or surgery | Dental Cleaning and MI Arm |
Primary outcome
Dental care-seeking behavior
Time frame: 12 months
Subject-reported dental visit since hospitalization, assessed at 12 months after intervention.
3 secondary outcomes
Healthcare costs
Time frame: Up to 24 months
Oral health-related quality of life
Time frame: 6 months
Change from baseline Hemoglobin A1c at 3 and 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Dental cleaning in people with Type II Diabetes and Periodontal Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental care-seeking behavior (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.