Diabetes MellitusNCT00012688
Periodontal Care and Glycemic Control in Diabetes
A study testing Doxycycline HCI 10mg po for 2 weeks and Ultrasonic scaling with 0.12% chlorhexidine gluconate in people with Diabetes Mellitus and Poor Glycemic Control, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. Improvements in periodontal status may also improve diabetes control. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Poor Glycemic Control, Peridontal Disease
- What is being tested?
- Doxycycline HCI 10mg po for 2 weeks and Ultrasonic scaling with 0.12% chlorhexidine gluconate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 2003
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have diabetes mellitus, and HbAlc >9, >8 teeth, and CPITN scores of 3 or 4 in, at least 2 sextants of the mouth, indicating moderate to high peridontal treatment need.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
About this study
Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. Improvements in periodontal status may also improve diabetes control.
Read the detailed description
Background:
Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. Improvements in periodontal status may also improve diabetes control.
Objectives:
This project will determine the efficacy of a program of periodontal screening and therapy in improving the level of glycemic control in poorly controlled diabetics.
Methods:
Status:
Subject accrual is complete. Data collection is ongoing.
- Conditions
- Diabetes Mellitus, Poor Glycemic Control, Peridontal Disease
- Being tested
- Doxycycline HCI 10mg po for 2 weeks, Ultrasonic scaling with 0.12% chlorhexidine gluconate
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline HCI 10mg po for 2 weeksDrug
Ultrasonic scaling with 0.12% chlorhexidine gluconateProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Drug: Doxycycline HCI 10mg po for 2 weeks; Procedure: Ultrasonic scaling with 0.12% chlorhexidine gluconate |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Single blind
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Colgate-Periogard-Dentsply
- Responsible party
- Sponsor
- Investigators
- Judith A. Jones, DDS DSc MPH, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012688
- Sponsor's protocol ID
- DII 99-206
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
McCoy LC, Wehler CJ, Rich SE, Garcia RI, Miller DR, Jones JA. Adverse events associated with chlorhexidine use: results from the Department of Veterans Affairs Dental Diabetes Study. J Am Dent Assoc. 2008 Feb;139(2):178-83. doi: 10.14219/jada.archive.2008.0134.
PubMed 18245686Janket SJ, Jones J, Rich S, Miller D, Wehler CJ, Van Dyke TE, Garcia R, Meurman JH. The effects of xerogenic medications on oral mucosa among the Veterans Dental Study participants. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Feb;103(2):223-30. doi: 10.1016/j.tripleo.2006.05.013. Epub 2006 Aug 4.
PubMed 17234540Jones JA, Miller DR, Wehler CJ, Rich SE, Krall-Kaye EA, McCoy LC, Christiansen CL, Rothendler JA, Garcia RI. Does periodontal care improve glycemic control? The Department of Veterans Affairs Dental Diabetes Study. J Clin Periodontol. 2007 Jan;34(1):46-52. doi: 10.1111/j.1600-051X.2006.01002.x. Epub 2006 Nov 24.
PubMed 17137468Jones JA, Miller DR, Wehler CJ, Rich S, Krall E, Christiansen CL, Rothendler JA, Garcia RI. Study design, recruitment, and baseline characteristics: the Department of Veterans Affairs Dental Diabetes Study. J Clin Periodontol. 2007 Jan;34(1):40-5. doi: 10.1111/j.1600-051X.2006.00998.x. Epub 2006 Oct 13.
PubMed 17040483Cunha-Cruz J, Hujoel PP, Kressin NR. Oral health-related quality of life of periodontal patients. J Periodontal Res. 2007 Apr;42(2):169-76. doi: 10.1111/j.1600-0765.2006.00930.x.
PubMed 17305876
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Care and Glycemic Control in Diabetes
- ClinicalTrials.gov ID
- NCT00012688
- Acronym / sponsor ID
- DII 99-206
- Conditions
- Diabetes Mellitus, Poor Glycemic Control, Peridontal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Colgate-Periogard-Dentsply
- Study completion
- Sep 2003 (actual)
- First posted
- 16 Mar 2001 (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.
Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. Improvements in periodontal status may also improve diabetes control.
Detailed description
Background:
Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. Improvements in periodontal status may also improve diabetes control.
Objectives:
This project will determine the efficacy of a program of periodontal screening and therapy in improving the level of glycemic control in poorly controlled diabetics.
Methods:
Status:
Subject accrual is complete. Data collection is ongoing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: Doxycycline HCI 10mg po for 2 weeks, Procedure: Ultrasonic scaling with 0.12% chlorhexidine gluconate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have diabetes mellitus, and HbAlc >9, >8 teeth, and CPITN scores of 3 or 4 in, at least 2 sextants of the mouth, indicating moderate to high peridontal treatment need.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Doxycycline HCI 10mg po for 2 weeks | Drug | Arm 1 |
| Ultrasonic scaling with 0.12% chlorhexidine gluconate | Procedure or surgery | Arm 1 |
Primary outcome
Not reported in the source record.
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 7 Apr 2015.
- Results publication: PubMed 18245686McCoy LC, Wehler CJ, Rich SE, Garcia RI, Miller DR, Jones JA. Adverse events associated with chlorhexidine use: results from the Department of Veterans Affairs Dental Diabetes Study. J Am Dent Assoc. 2008 Feb;139(2):178-83. doi: 10.14219/jada.archive.2008.0134.
- Results publication: PubMed 17234540Janket SJ, Jones J, Rich S, Miller D, Wehler CJ, Van Dyke TE, Garcia R, Meurman JH. The effects of xerogenic medications on oral mucosa among the Veterans Dental Study participants. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Feb;103(2):223-30. doi: 10.1016/j.tripleo.2006.05.013. Epub 2006 Aug 4.
- Results publication: PubMed 17137468Jones JA, Miller DR, Wehler CJ, Rich SE, Krall-Kaye EA, McCoy LC, Christiansen CL, Rothendler JA, Garcia RI. Does periodontal care improve glycemic control? The Department of Veterans Affairs Dental Diabetes Study. J Clin Periodontol. 2007 Jan;34(1):46-52. doi: 10.1111/j.1600-051X.2006.01002.x. Epub 2006 Nov 24.
- Results publication: PubMed 17040483Jones JA, Miller DR, Wehler CJ, Rich S, Krall E, Christiansen CL, Rothendler JA, Garcia RI. Study design, recruitment, and baseline characteristics: the Department of Veterans Affairs Dental Diabetes Study. J Clin Periodontol. 2007 Jan;34(1):40-5. doi: 10.1111/j.1600-051X.2006.00998.x. Epub 2006 Oct 13.
- Results publication: PubMed 17305876Cunha-Cruz J, Hujoel PP, Kressin NR. Oral health-related quality of life of periodontal patients. J Periodontal Res. 2007 Apr;42(2):169-76. doi: 10.1111/j.1600-0765.2006.00930.x.
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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.
Judith A. Jones, DDS DSc MPH principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline HCI 10mg po for 2 weeks and Ultrasonic scaling with 0.12% chlorhexidine gluconate in people with Diabetes Mellitus and Poor Glycemic Control, run by US Department of Veterans Affairs 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 1 inclusion and 0 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 7 Apr 2015. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00012688, which also lists 5 linked publications.
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 7 Apr 2015.