Periodontal DiseasePhase 2NCT00016835
Treating Periodontal Infection: Effects on Glycemic
A Phase 2 study testing Subgingival scaling and metronidazole and Subgingival scaling and doxycycline in people with Periodontal Disease and Diabetes Mellitus, Type 2, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this project is to obtain important preliminary data necessary to support design of a full scale, multicenter randomized clinical trial (RCT) to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Disease, Diabetes Mellitus, Type 2
- What is being tested?
- Subgingival scaling and metronidazole and Subgingival scaling and doxycycline
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2001to 3 Sep 2004
- Phase
- Phase 2
- 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
- Subjects must be 18 years of age or older,
- have at least six natural teeth,
- have established periodontal disease (established at the screening examination),
- have a history of type 2 diabetes of at least six months with HbAlc > 7.1%.
Who cannot join
- Subjects will be excluded from the study if they are presently under the care of a periodontist;
- have had antibiotic treatment within the previous three months;
- have conditions that require antibiotic prophylaxis for dental treatment;
- have allergies to iodine, doxycycline, metronidazole, or chlorhexidine;
- have blood dyscrasias;
- are pregnant or breast feeding;
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- have severe cognitive or communication impairment;
- have a cardiac pacemaker;
- are under cancer chemotherapy;
- are medically unstable or have a life expectancy of less than two years;
- are currently taking disulfiram, phenobarbital, lithium, terfenadine, astemizole, or warfarin;
- or are out of town or otherwise unavailable for more than three consecutive months of the year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Cariology, Restorative Sciences and Endodontics
Ann Arbor, Michigan, 48109-1078
About this study
Official title: Treating Periodontal Infection: Effects on Glycemic Control in People With Type 2 Diabetes
The purpose of this project is to obtain important preliminary data necessary to support design of a full scale, multicenter randomized clinical trial (RCT) to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes mellitus.
Read the detailed description
There is compelling epidemiological and clinical evidence to suggest that periodontal infection adversely affects glycemic control in people with type 2 diabetes mellitus. The purpose of this pilot project is to obtain important preliminary data necessary to support design of a full scale, multi-center randomized clinical trial (RCT) to evaluate the effect of treating periodontal infection on glycemic control in individuals with type 2 diabetes mellitus. This current project involves treating periodontal infection to obtain estimates of changes and the variability of those changes over time in the established primary endpoint, hemoglobin A1c (HbA1c). This project will also explore use of several potential secondary endpoints including levels of periodontitis and glucose metabolism-related inflammatory mediators (TNF-alpha, IL-1-beta, IL-6), serum cholesterol, triglyceride and lipids. Subjects are randomly assigned to 1 of three possible groups for comprehensive periodontal examination, specimen collection, mechanical periodontal therapy and oral systemic antibiotics or placebo, and regular follow-up evaluations and site-specific mechanical periodontal therapy, at 3-month intervals, for approximately 15 months. Two groups receive ultrasonic scaling with local anesthesia (as needed), local antimicrobial treatment with povidone-iodine irrigation, and an oral systemic antibiotic (either doxycycline or metronidazole) at the initial treatment visit. The third group ("controls") receives a placebo and supra-gingival oral prophylaxis and ultrasonic removal of supra-gingival calculus with water irrigation at the initial treatment visit. At the 9-month follow-up visit, "controls" receive sub-gingival ultrasonic scaling with povidone-iodine irrigation.
Results from this pilot project will be used as preliminary data to support design of an immediate follow-up proposal to NIH/NIDCR for funding a multi-center RCT to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes. If results from the full scale clinical trial provide evidence that treating periodontal infection contributes to improved glycemic control, then diagnosis and treatment of periodontal infection in subjects with type 2 diabetes could be substantiated as an important component in management of diabetes.
- Conditions
- Periodontal Disease, Diabetes Mellitus, Type 2
- Being tested
- Supra-gingival scaling and placebo, Subgingival scaling and metronidazole, Subgingival scaling and doxycycline
- Keywords
- Type 2 diabetes mellitus, Glycemic control, Periodontal therapy
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supra-gingival scaling and placeboProcedure or surgery
Included in arm/group description.
Subgingival scaling and metronidazoleProcedure or surgery
Included in arm/group description.
Subgingival scaling and doxycyclineProcedure or surgery
Included in arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| Supra-gingival scaling and placebo | Active comparator | This group receives a placebo (instead of systemic antibiotic), supra-gingival oral prophylaxis, and ultrasonic removal of supra-gingival calculus with water irrigation at the initial treatment visit. At the 9-month follow-up visit, this group will receive sub-gingival ultrasonic scaling with povidone-iodine irrigation.
This group also receives regular follow-up evaluations and site-specific mechanical periodontal therapy, at 3-month intervals, for approximately 15 months. Receives: Procedure: Supra-gingival scaling and placebo |
| Subgingival scaling and metronidazole | Experimental | This group receives ultrasonic scaling with local anesthesia (as needed), local antimicrobial treatment with povidone-iodine irrigation, and metronidazole as an oral systemic antibiotic at the initial treatment visit.
This group also receives regular follow-up evaluations and site-specific mechanical periodontal therapy, at 3-month intervals, for approximately 15 months. Receives: Procedure: Subgingival scaling and metronidazole |
| Subgingival scaling and doxycycline | Experimental | This group receives ultrasonic scaling with local anesthesia (as needed), local antimicrobial treatment with povidone-iodine irrigation, and doxycycline as an oral systemic antibiotic at the initial treatment visit.
This group also receives regular follow-up evaluations and site-specific mechanical periodontal therapy, at 3-month intervals, for approximately 15 months. Receives: Procedure: Subgingival scaling and doxycycline |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2001 (estimated)
- Study start17 Oct 2001
- Primary completion3 Sep 2004
- Study completion3 Sep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants were randomized into 3 groups for the initial non-surgical treatment appointment. One group received supra-gingival scaling and placebo, one group received non-surgical periodontal supra- and sub-gingival scaling plus metronidazole and one group received non-surgical periodontal supra- and sub-gingival scaling plus doxycycline. All three groups received 3-month follow-up visits for 15 months and the group receiving supra-gingival scaling and placebo at the initial visit received supra- and sub-gingival scaling at the 9-month follow-up visit.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, George W. Taylor, University of Michigan
- Investigators
- George W. Taylor, DMD, Dr.PH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016835
- Sponsor's protocol ID
- NIDCR-03
- Other IDs
- 5R01DE013796-03
- Status last verified
- Jul 2017
- First submitted
- 5 Jun 2001
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no current plan to share data with other researchers at this time
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Periodontal Infection: Effects on Glycemic Control in People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00016835
- Acronym / sponsor ID
- NIDCR-03
- Conditions
- Periodontal Disease, Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes mellitus, Glycemic control, Periodontal therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 17 Oct 2001 (actual)
- Primary completion
- 3 Sep 2004 (actual)
- Study completion
- 3 Sep 2004 (actual)
- First posted
- 7 Jun 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.
The purpose of this project is to obtain important preliminary data necessary to support design of a full scale, multicenter randomized clinical trial (RCT) to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes mellitus.
Detailed description
There is compelling epidemiological and clinical evidence to suggest that periodontal infection adversely affects glycemic control in people with type 2 diabetes mellitus. The purpose of this pilot project is to obtain important preliminary data necessary to support design of a full scale, multi-center randomized clinical trial (RCT) to evaluate the effect of treating periodontal infection on glycemic control in individuals with type 2 diabetes mellitus. This current project involves treating periodontal infection to obtain estimates of changes and the variability of those changes over time in the established primary endpoint, hemoglobin A1c (HbA1c). This project will also explore use of several potential secondary endpoints including levels of periodontitis and glucose metabolism-related inflammatory mediators (TNF-alpha, IL-1-beta, IL-6), serum cholesterol, triglyceride and lipids. Subjects are randomly assigned to 1 of three possible groups for comprehensive periodontal examination, specimen collection, mechanical periodontal therapy and oral systemic antibiotics or placebo, and regular follow-up evaluations and site-specific mechanical periodontal therapy, at 3-month intervals, for approximately 15 months. Two groups receive ultrasonic scaling with local anesthesia (as needed), local antimicrobial treatment with povidone-iodine irrigation, and an oral systemic antibiotic (either doxycycline or metronidazole) at the initial treatment visit. The third group ("controls") receives a placebo and supra-gingival oral prophylaxis and ultrasonic removal of supra-gingival calculus with water irrigation at the initial treatment visit. At the 9-month follow-up visit, "controls" receive sub-gingival ultrasonic scaling with povidone-iodine irrigation.
Results from this pilot project will be used as preliminary data to support design of an immediate follow-up proposal to NIH/NIDCR for funding a multi-center RCT to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes. If results from the full scale clinical trial provide evidence that treating periodontal infection contributes to improved glycemic control, then diagnosis and treatment of periodontal infection in subjects with type 2 diabetes could be substantiated as an important component in management of diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Study participants were randomized into 3 groups for the initial non-surgical treatment appointment. One group received supra-gingival scaling and placebo, one group received non-surgical periodontal supra- and sub-gingival scaling plus metronidazole and one group received non-surgical periodontal supra- and sub-gingival scaling plus doxycycline. All three groups received 3-month follow-up visits for 15 months and the group receiving supra-gingival scaling and placebo at the initial visit received supra- and sub-gingival scaling at the 9-month follow-up visit.
| Arm | Type | Receives |
|---|---|---|
| Supra-gingival scaling and placebo | Active comparator | Procedure: Supra-gingival scaling and placeboThis group receives a placebo (instead of systemic antibiotic), supra-gingival oral prophylaxis, and ultrasonic removal of supra-gingival calculus with water irrigation at the initial treatment visit. At the 9-month follow-up visit, this group will receive sub-gingival ultrasonic scaling with povidone-iodine irrigation. This group also receives regular follow-up evaluations and site-specific mechanical periodontal therapy, at 3-month intervals, for approximately 15 months. |
| Subgingival scaling and metronidazole | Experimental | Procedure: Subgingival scaling and metronidazoleThis group receives ultrasonic scaling with local anesthesia (as needed), local antimicrobial treatment with povidone-iodine irrigation, and metronidazole as an oral systemic antibiotic at the initial treatment visit. This group also receives regular follow-up evaluations and site-specific mechanical periodontal therapy, at 3-month intervals, for approximately 15 months. |
| Subgingival scaling and doxycycline | Experimental | Procedure: Subgingival scaling and doxycyclineThis group receives ultrasonic scaling with local anesthesia (as needed), local antimicrobial treatment with povidone-iodine irrigation, and doxycycline as an oral systemic antibiotic at the initial treatment visit. This group also receives regular follow-up evaluations and site-specific mechanical periodontal therapy, at 3-month intervals, for approximately 15 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be 18 years of age or older,
- have at least six natural teeth,
- have established periodontal disease (established at the screening examination),
- have a history of type 2 diabetes of at least six months with HbAlc > 7.1%.
Key exclusion criteria (12 listed)
- Subjects will be excluded from the study if they are presently under the care of a periodontist;
- have had antibiotic treatment within the previous three months;
- have conditions that require antibiotic prophylaxis for dental treatment;
- have allergies to iodine, doxycycline, metronidazole, or chlorhexidine;
- have blood dyscrasias;
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 |
|---|---|---|
| Supra-gingival scaling and placeboIncluded in arm/group description. | Procedure or surgery | Supra-gingival scaling and placebo |
| Subgingival scaling and metronidazoleIncluded in arm/group description. | Procedure or surgery | Subgingival scaling and metronidazole |
| Subgingival scaling and doxycyclineIncluded in arm/group description. | Procedure or surgery | Subgingival scaling and doxycycline |
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 19 Jul 2017.
- Individual participant dataSharing planned: No. There is no current plan to share data with other researchers at this time
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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.
George W. Taylor, DMD, Dr.PH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Subgingival scaling and metronidazole and Subgingival scaling and doxycycline in people with Periodontal Disease and Diabetes Mellitus, Type 2, run by University of Michigan 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 12 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 19 Jul 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 19 Jul 2017.