Chronic PeriodontitisPhase 3DPTTNCT00997178
Diabetes and Periodontal Therapy Trial
A Phase 3 study testing Non-surgical periodontal therapy and Delayed non-surgical periodontal therapy in people with Chronic Periodontitis and Type 2 Diabetes, run by Stony Brook University at 8 sites in United States.
Trial summary
The primary aim of the study is to determine if non-surgical periodontal therapy (scaling and root planing and supportive periodontal therapy) is efficacious compared to delayed therapy in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabetes and untreated… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Periodontitis, Type 2 Diabetes
- What is being tested?
- Non-surgical periodontal therapy and Delayed non-surgical periodontal therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2009to Dec 2012
- Phase
- Phase 3
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 35 years of age
- Screening HbA1c value ≥ 7% and <9%
- Physician diagnosed type 2 diabetes of more than three months duration
- Currently under the care of a physician for diabetes management
- No change in diabetes-related medications during the three months prior to enrollment. Change is defined as any of the following: change in dose of any 1 hyperglycemic drug by more than two-fold, change in dose of insulin of more than 10%, addition or subtraction of an oral hyperglycemic agent or insulin.
- Consent to contact treating physician and obtain physician agreement to refrain from changing diabetes- related medications during DPTT participation unless overt symptoms develop (e.g. polydipsia, polyuria), HbA1c is 9.5% or higher
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- Moderate to severe chronic periodontitis, defined as loss of clinical attachment and probing depth of ≥5 mm at two sites in the mouth in 2 or more quadrants
- No definitive periodontal treatment during the six months prior to enrollment
- Likely to have at least 16 natural teeth for the entire length of study
- Informed consent obtained and signed
- Ability and willingness to cooperate with the study protocol and attend all study visits over the next 9 months
- Willingness to avoid pregnancy during study participation
Who cannot join
- Self-reported serious concurrent disease that at the discretion of the referring physician limits life expectancy to less than 1 year.
- Emergency room visit or physician visit within the last 30 days because of hyperglycemia or diabetes complications.
- Chronic or continuous use (daily for more than 7 consecutive days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months, other than low dose aspirin (e.g. 75-325 mg/day).
- Receiving chronic treatment with systemic corticosteroids, cyclosporine or other systemic immunosuppressive drugs
- Chronic treatment with systemic antibiotics (antibiotics for > 7 consecutive days within 30 days of baseline visit).
- Currently receiving dialysis.
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- At increased risk of bleeding complications from dental treatment, based on medical history.
- Requires Essential Dental Care (e.g., treatment for grossly decayed teeth, broken teeth, dental abscesses, peri-apical infections, other dental infections).
- Heavy alcohol consumption (on average > 2 drinks/day for women and > 3 drinks/day for men).
- Currently pregnant or considering becoming pregnant within the 6 month follow-up period
- Any other criteria that in the opinion of the investigator would preclude study completion or problems with compliance
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Clinical Site: University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Texas, Health Sciences Center at Houston
Houston, Texas, 77030
Clinical Site: University of Minnesota
Minneapolis, Minnesota, 55455
Core Laboratory: University of Minnesota
Minneapolis, Minnesota, 55455
Clinical Site: University of Texas Health Science Center
San Antonio, Texas, 78229
Coordinating Center: Stony Brook University-
Stony Brook, New York, 11794-8036
Administrative Center/Study Chair's Office: Stony Brook University
Stony Brook, New York, 11794
Clinical Site: Stony Brook University
Stony Brook, New York, 11794
About this study
Official title: A Multicenter Randomized Single-Masked Clinical Trial Testing the Effect of Non-surgical Periodontal Therapy on Glycosylated Hemoglobin (HbA1c) Levels in Subjects With Type 2 Diabetes and Chronic Periodontitis
The primary aim of the study is to determine if non-surgical periodontal therapy (scaling and root planing and supportive periodontal therapy) is efficacious compared to delayed therapy in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis.
The secondary aims of the study are to:
- evaluate whether 6 month (or shorter-term (3 month)) changes in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level) are related to changes in HbA1c and fasting glucose or insulin resistance as measured by the Homeostasis Model Assessment 2 (HOMA2).
- assess the 3 month and 6 month efficacy of periodontal therapy on all of the above study outcomes. If a treatment response is observed for any of the study outcomes at 3 months, then the trial can evaluate whether this response is sustained at 6 months.
Read the detailed description
This study is a multicenter, randomized, controlled, single-masked, Phase III trial to determine if non-surgical periodontal therapy (scaling and root planing) is efficacious in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis. Six hundred adults with a diagnosis of type 2 diabetes and chronic periodontitis will be randomized at three Clinical Sites; University of Alabama at Birmingham; the University of Minnesota, Minneapolis; and the University of Texas Health Science Center, San Antonio. The Core Laboratory will be located at the University of Minnesota and the Study Chair's Office and Coordinating Center will be located at Stony Brook University, Stony Brook, New York.
Eligible participants will be randomly assigned to receive either initial non-surgical periodontal therapy with chlorhexidine rinse (treatment subjects) or delayed non-surgical periodontal therapy (control subjects). Control subjects will be offered delayed periodontal therapy (scaling and root planing) following the 6 month visit. Participants meeting all other eligibility criteria and needing essential dental care, i.e., for broken, grossly carious or abscessed teeth, may enroll only following completion of necessary dental treatment. Participants in both study arms will receive oral hygiene instruction and healthy lifestyle information (e.g. diet, exercise) at baseline and at the 3 and 6 month visits.
Periodontal data will be recorded by trained and calibrated examiners at baseline and 3 and 6 months following randomization. Fasting blood will collected at baseline and at 3 and 6 months to measure intermediate links in the putative causal chain between periodontitis and glycemic control. The periodontal health of all subjects will be monitored, and any subject who experiences progressive periodontitis during the study will be provided with non-surgical rescue therapy.
- Conditions
- Chronic Periodontitis, Type 2 Diabetes
- Being tested
- Non-surgical periodontal therapy, Delayed non-surgical periodontal therapy
- Keywords
- Diabetes, Diabetes Mellitus, Periodontal Disease, Periodontitis, Glycosylated Hemoglobin, HbA1c
- Medical subject headings
- Chronic Periodontitis, Diabetes Mellitus, Type 2, Diabetes Mellitus, Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal therapyProcedure or surgery
Non-surgical periodontal therapy (scaling and root planing)and supportive periodontal therapy with chlorhexidine rinse
Delayed non-surgical periodontal therapyOther
Delayed non-surgical periodontal therapy (scaling and root planing) after the 6 month visit
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical periodontal therapy | Experimental | Non-surgical periodontal therapy consisted of scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months Receives: Procedure: Non-surgical periodontal therapy |
| Delayed non-surgical periodontal therapy | Other | No periodontal treatment for 6 months Receives: Other: Delayed non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Hemoglobin (HbA1c)
Measured: 6 months after randomization
Secondary outcomes (6)
Change in glycosylated hemoglobin (HbA1c)
Measured: 3 months after randomization
Change in Fasting Plasma Glucose and Homeostasis Model Assessment 2 (HOMA2)
Measured: 3 and 6 months after randomization
Change in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level)
Measured: 3 and 6 months after randomization
Need for Periodontal Rescue Therapy
Measured: When required
Change in diabetes medications
Measured: 3 and 6 months after randomization
Need for Diabetes Rescue Therapy
Measured: When required
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of Minnesota, The University of Texas Health Science Center, Houston, The University of Texas Health Science Center at San Antonio, National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Steven Engebretson, DMD, MS, MS, Study chair, Stony Brook UniversityLeslie Hyman, PhD, Study director, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997178
- Sponsor's protocol ID
- NIDCR:07-003
- Other IDs
- U01DE018902-01, U01DE018886-01
- Acronym
- DPTT
- Status last verified
- Jan 2014
- First submitted
- 16 Oct 2009
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Engebretson SP, Hyman LG, Michalowicz BS, Schoenfeld ER, Gelato MC, Hou W, Seaquist ER, Reddy MS, Lewis CE, Oates TW, Tripathy D, Katancik JA, Orlander PR, Paquette DW, Hanson NQ, Tsai MY. The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial. JAMA. 2013 Dec 18;310(23):2523-32. doi: 10.1001/jama.2013.282431.
PubMed 24346989Geisinger ML, Michalowicz BS, Hou W, Schoenfeld E, Gelato M, Engebretson SP, Reddy MS, Hyman L. Systemic Inflammatory Biomarkers and Their Association With Periodontal and Diabetes-Related Factors in the Diabetes and Periodontal Therapy Trial, A Randomized Controlled Trial. J Periodontol. 2016 Aug;87(8):900-13. doi: 10.1902/jop.2016.150727. Epub 2016 Apr 25.
PubMed 27108476DPTT study group; Engebretson S, Gelato M, Hyman L, Michalowicz BS, Schoenfeld E. Design features of the Diabetes and Periodontal Therapy Trial (DPTT): a multicenter randomized single-masked clinical trial testing the effect of nonsurgical periodontal therapy on glycosylated hemoglobin (HbA1c) levels in subjects with type 2 diabetes and chronic periodontitis. Contemp Clin Trials. 2013 Nov;36(2):515-26. doi: 10.1016/j.cct.2013.09.010. Epub 2013 Sep 27.
PubMed 24080100
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Single-Masked Clinical Trial Testing the Effect of Non-surgical Periodontal Therapy on Glycosylated Hemoglobin (HbA1c) Levels in Subjects With Type 2 Diabetes and Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT00997178
- Acronym / sponsor ID
- DPTT / NIDCR:07-003
- Conditions
- Chronic Periodontitis, Type 2 Diabetes
- Keywords
- Diabetes, Diabetes Mellitus, Periodontal Disease, Periodontitis, Glycosylated Hemoglobin, HbA1c
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of Minnesota, The University of Texas Health Science Center, Houston, The University of Texas Health Science Center at San Antonio, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Oct 2009 (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 primary aim of the study is to determine if non-surgical periodontal therapy (scaling and root planing and supportive periodontal therapy) is efficacious compared to delayed therapy in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis.
The secondary aims of the study are to:
- evaluate whether 6 month (or shorter-term (3 month)) changes in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level) are related to changes in HbA1c and fasting glucose or insulin resistance as measured by the Homeostasis Model Assessment 2 (HOMA2).
- assess the 3 month and 6 month efficacy of periodontal therapy on all of the above study outcomes. If a treatment response is observed for any of the study outcomes at 3 months, then the trial can evaluate whether this response is sustained at 6 months.
Detailed description
This study is a multicenter, randomized, controlled, single-masked, Phase III trial to determine if non-surgical periodontal therapy (scaling and root planing) is efficacious in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis. Six hundred adults with a diagnosis of type 2 diabetes and chronic periodontitis will be randomized at three Clinical Sites; University of Alabama at Birmingham; the University of Minnesota, Minneapolis; and the University of Texas Health Science Center, San Antonio. The Core Laboratory will be located at the University of Minnesota and the Study Chair's Office and Coordinating Center will be located at Stony Brook University, Stony Brook, New York.
Eligible participants will be randomly assigned to receive either initial non-surgical periodontal therapy with chlorhexidine rinse (treatment subjects) or delayed non-surgical periodontal therapy (control subjects). Control subjects will be offered delayed periodontal therapy (scaling and root planing) following the 6 month visit. Participants meeting all other eligibility criteria and needing essential dental care, i.e., for broken, grossly carious or abscessed teeth, may enroll only following completion of necessary dental treatment. Participants in both study arms will receive oral hygiene instruction and healthy lifestyle information (e.g. diet, exercise) at baseline and at the 3 and 6 month visits.
Periodontal data will be recorded by trained and calibrated examiners at baseline and 3 and 6 months following randomization. Fasting blood will collected at baseline and at 3 and 6 months to measure intermediate links in the putative causal chain between periodontitis and glycemic control. The periodontal health of all subjects will be monitored, and any subject who experiences progressive periodontitis during the study will be provided with non-surgical rescue therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-surgical periodontal therapy | Experimental | Procedure: Non-surgical periodontal therapyNon-surgical periodontal therapy consisted of scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months |
| Delayed non-surgical periodontal therapy | Other | Other: Delayed non-surgical periodontal therapyNo periodontal treatment for 6 months |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- At least 35 years of age
- Screening HbA1c value ≥ 7% and <9%
- Physician diagnosed type 2 diabetes of more than three months duration
- Currently under the care of a physician for diabetes management
- No change in diabetes-related medications during the three months prior to enrollment. Change is defined as any of the following: change in dose of any 1 hyperglycemic drug by more than two-fold, change in dose of insulin of more than 10%, addition or subtraction of an oral hyperglycemic agent or insulin.
Key exclusion criteria (11 listed)
- Self-reported serious concurrent disease that at the discretion of the referring physician limits life expectancy to less than 1 year.
- Emergency room visit or physician visit within the last 30 days because of hyperglycemia or diabetes complications.
- Chronic or continuous use (daily for more than 7 consecutive days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months, other than low dose aspirin (e.g. 75-325 mg/day).
- Receiving chronic treatment with systemic corticosteroids, cyclosporine or other systemic immunosuppressive drugs
- Chronic treatment with systemic antibiotics (antibiotics for > 7 consecutive days within 30 days of baseline visit).
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 |
|---|---|---|
| Non-surgical periodontal therapyNon-surgical periodontal therapy (scaling and root planing)and supportive periodontal therapy with chlorhexidine rinse | Procedure or surgery | Non-surgical periodontal therapy |
| Delayed non-surgical periodontal therapyDelayed non-surgical periodontal therapy (scaling and root planing) after the 6 month visit | Other | Delayed non-surgical periodontal therapy |
Primary outcome
Change in Glycosylated Hemoglobin (HbA1c)
Time frame: 6 months after randomization
6 secondary outcomes
Change in glycosylated hemoglobin (HbA1c)
Time frame: 3 months after randomization
Change in Fasting Plasma Glucose and Homeostasis Model Assessment 2 (HOMA2)
Time frame: 3 and 6 months after randomization
Change in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level)
Time frame: 3 and 6 months after randomization
Need for Periodontal Rescue Therapy
Time frame: When required
Change in diabetes medications
Time frame: 3 and 6 months after randomization
Need for Diabetes Rescue Therapy
Time frame: When required
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 20 Jan 2014.
- Results publication: PubMed 24346989Engebretson SP, Hyman LG, Michalowicz BS, Schoenfeld ER, Gelato MC, Hou W, Seaquist ER, Reddy MS, Lewis CE, Oates TW, Tripathy D, Katancik JA, Orlander PR, Paquette DW, Hanson NQ, Tsai MY. The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial. JAMA. 2013 Dec 18;310(23):2523-32. doi: 10.1001/jama.2013.282431.
- Derived from this study: PubMed 27108476Geisinger ML, Michalowicz BS, Hou W, Schoenfeld E, Gelato M, Engebretson SP, Reddy MS, Hyman L. Systemic Inflammatory Biomarkers and Their Association With Periodontal and Diabetes-Related Factors in the Diabetes and Periodontal Therapy Trial, A Randomized Controlled Trial. J Periodontol. 2016 Aug;87(8):900-13. doi: 10.1902/jop.2016.150727. Epub 2016 Apr 25.
- Derived from this study: PubMed 24080100DPTT study group; Engebretson S, Gelato M, Hyman L, Michalowicz BS, Schoenfeld E. Design features of the Diabetes and Periodontal Therapy Trial (DPTT): a multicenter randomized single-masked clinical trial testing the effect of nonsurgical periodontal therapy on glycosylated hemoglobin (HbA1c) levels in subjects with type 2 diabetes and chronic periodontitis. Contemp Clin Trials. 2013 Nov;36(2):515-26. doi: 10.1016/j.cct.2013.09.010. Epub 2013 Sep 27.
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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.
Steven Engebretson, DMD, MS, MS study chair
Stony Brook University
Leslie Hyman, PhD study director
Stony Brook University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Non-surgical periodontal therapy and Delayed non-surgical periodontal therapy in people with Chronic Periodontitis and Type 2 Diabetes, run by Stony Brook University at 8 sites 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 12 inclusion and 11 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 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Change in Glycosylated Hemoglobin (HbA1c) (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00997178, which also lists 3 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 20 Jan 2014.