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Undiagnosed Diabetes in a Dental Setting

Primary Purpose

Prediabetic State, Type 2 Diabetes Mellitus With Oral Complications, Periodontal Pocket

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced intervention
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prediabetic State focused on measuring Oral Health, Prediabetes, Diabetes, Periodontitis, Early Identification, Prevention

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient who presents at the Columbia University College of Dental Medicine dental clinic
  • Never been told that pre-diabetic or diabetic
  • 40 years old or older, if white
  • 30 years old or older, if non-white
  • If female, not pregnant
  • Not completely edentulous
  • Able to undergo a periodontal examination

Exclusion Criteria:

  • Previously told by physician that prediabetes or diabetes is present
  • < 40 years of age if non-hispanic and white, and < 30 years of age if hispanic or non-white
  • For medical or other reasons cannot tolerate a periodontal exam
  • If female, pregnant
  • Fully edentulous

Sites / Locations

  • Columbia University College of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard practice

Enhanced intervention

Arm Description

Study patients are notified of their "diagnostic" test result within 72 hours. Those identified as potentially pre-diabetic or diabetic and randomized to the basic/control intervention, are informed that it is important to follow-up with their physician regarding their test results. They are contacted by phone once to schedule their 6-month recall visit.

Study patients are notified of their "diagnostic" test result within 72 hours. Those identified as potentially pre-diabetic or diabetic and randomized to the enhanced group, receive a tailored message about their modifiable risks and are advised to see their physician regarding their test results. They are given a letter to take to their physician and receive a call at month two and then again at month four if necessary to inquire if they have followed-up with their physician and encouragement to do so, if they have not, prior to their six month follow-up study visit.

Outcomes

Primary Outcome Measures

Occurrence of follow-up visit to physician regarding screening result
Investigators want to determine if the enhanced intervention increases the likelihood that study participants identified as potentially pre-diabetic or diabetic visit their physician to discuss the screening results of their and to receive advice from their physician, relative to participants in the standard practice group.

Secondary Outcome Measures

Decrease in HbA1c
Investigators want to determine if study participants who receive the enhanced intervention have an improved HbA1c test result, relative to standard practice group participants, upon re-testing during a second study visit at 6 months.
Improved periodontal measures
Investigators want to determine if the participants who receive the enhanced intervention are found to have improved periodontal findings, relative to standard practice group participants, upon re-examination during a second study visit at 6 months.

Full Information

First Posted
October 10, 2012
Last Updated
August 13, 2021
Sponsor
Columbia University
Collaborators
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT01711385
Brief Title
Undiagnosed Diabetes in a Dental Setting
Official Title
Screening for Undiagnosed Diabetes in a Dental Setting - A New Paradigm for Dental Practice
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Colgate Palmolive

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In an ongoing study new dental patients are screened to determine their risk of having undiagnosed pre-diabetes or diabetes based on risk factors readily known by the patient and signs of gum disease. Investigators further seek to assess if a post-identification intervention leads to a greater likelihood of study participants identified as potentially pre-diabetic or diabetic visiting their physician regarding their screening blood test results, and to improved health outcomes.
Detailed Description
Approximately 3% to 4% of the U.S. adult population has undiagnosed diabetes and the prevalence is likely to be substantially higher among people with risk factors for diabetes. Of note, many patients at the time of diagnosis of diabetes already have diabetic complications. This indicates that there is a period of "asymptomatic" diabetes during which hyperglycemia and other risk factors are present and complications are developing. This substantial delay in clinical diagnosis of diabetes involves a period of about 10-12 years that elapses between onset of diabetes and its diagnosis. Early diagnosis of diabetes, with treatment aiming at strict control of blood glucose levels, is important in preventing or mitigating its clinical complications and improving health outcomes. Oral findings may offer an unrealized opportunity for the identification of affected individuals unaware of their condition. Previous research suggests that oral healthcare professionals have the opportunity to identify unrecognized diabetes and pre-diabetes in dental patients and refer them to a physician for further evaluation and care. Based on these findings, efforts to identify dental patients' risk of having undiagnosed pre-diabetes or diabetes, using a new diagnostic blood test as the outcome (HPLC HbA1c), continue. In addition, a subgroup of study subjects identified as potentially pre-diabetic or diabetic are randomly assigned to either a group 1/basic-standard intervention arm or to a group 2/enhanced intervention arm. The investigators seek to determine if a post-identification intervention leads to a greater likelihood of study participants identified as potentially pre-diabetic or diabetic visiting their physician regarding their blood test results and to improved health outcomes. Results of this pilot study have the potential to set in motion far ranging, changes in the practice of dentistry, leading to the advancement of a new paradigm in dental practice that calls for the adoption of a more holistic approach to patient care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State, Type 2 Diabetes Mellitus With Oral Complications, Periodontal Pocket, Tooth Loss
Keywords
Oral Health, Prediabetes, Diabetes, Periodontitis, Early Identification, Prevention

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard practice
Arm Type
No Intervention
Arm Description
Study patients are notified of their "diagnostic" test result within 72 hours. Those identified as potentially pre-diabetic or diabetic and randomized to the basic/control intervention, are informed that it is important to follow-up with their physician regarding their test results. They are contacted by phone once to schedule their 6-month recall visit.
Arm Title
Enhanced intervention
Arm Type
Experimental
Arm Description
Study patients are notified of their "diagnostic" test result within 72 hours. Those identified as potentially pre-diabetic or diabetic and randomized to the enhanced group, receive a tailored message about their modifiable risks and are advised to see their physician regarding their test results. They are given a letter to take to their physician and receive a call at month two and then again at month four if necessary to inquire if they have followed-up with their physician and encouragement to do so, if they have not, prior to their six month follow-up study visit.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced intervention
Intervention Description
Study patients are notified of their blood test result within 72 hours. Those identified as potentially pre-diabetic or diabetic, and randomized to the enhanced intervention arm, receive a tailored message about their modifiable risks and are advised to see their physician regarding their test results or are provided with a referral to one. They are given a letter to take to their physician that specifies the risk factors identified, the tests carried out for the patient and the exact numeric results. They receive a call at month 2 to see if they have followed up with a physician regarding their test results. If they have not seen a physician regarding their results, they are advised again to do so and reminded of their individual risk factors. At month 4 they are asked again if they have seen a physician regarding their test results. If they still have not seen a physician at this time the message is reinforced. They are contacted again by phone to schedule the 6-month recall visit.
Primary Outcome Measure Information:
Title
Occurrence of follow-up visit to physician regarding screening result
Description
Investigators want to determine if the enhanced intervention increases the likelihood that study participants identified as potentially pre-diabetic or diabetic visit their physician to discuss the screening results of their and to receive advice from their physician, relative to participants in the standard practice group.
Time Frame
Baseline up to six months
Secondary Outcome Measure Information:
Title
Decrease in HbA1c
Description
Investigators want to determine if study participants who receive the enhanced intervention have an improved HbA1c test result, relative to standard practice group participants, upon re-testing during a second study visit at 6 months.
Time Frame
Baseline up to six months
Title
Improved periodontal measures
Description
Investigators want to determine if the participants who receive the enhanced intervention are found to have improved periodontal findings, relative to standard practice group participants, upon re-examination during a second study visit at 6 months.
Time Frame
Baseline up to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient who presents at the Columbia University College of Dental Medicine dental clinic Never been told that pre-diabetic or diabetic 40 years old or older, if white 30 years old or older, if non-white If female, not pregnant Not completely edentulous Able to undergo a periodontal examination Exclusion Criteria: Previously told by physician that prediabetes or diabetes is present < 40 years of age if non-hispanic and white, and < 30 years of age if hispanic or non-white For medical or other reasons cannot tolerate a periodontal exam If female, pregnant Fully edentulous
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira B. Lamster, DDS, M.M.Sc.
Organizational Affiliation
Columbia University College of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University College of Dental Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Undiagnosed Diabetes in a Dental Setting

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