Type II DiabetesNCT01881074
Periodontal Treatment Response in Type II Diabetic Patients
An observational study of Type II Diabetes and Periodontal Disease, run by University of Florida at 1 site in United States.
Trial summary
Diabetes mellitus affects > 171 million people worldwide, with type II diabetes being the most prevalent, affecting 85-95% of the diabetic population. Unfortunately, despite conventional medical treatment, some diabetic patients do not seem to be able to reach desirable metabolic control. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type II Diabetes, Periodontal Disease
- What is being tested?
- Triclosan containing toothpaste and Non-triclosan containing toothpaste
- Type of treatment
- Pill or oral medicine
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2015
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type II diabetic patients with periodontal disease requiring periodontal treatment.
Who may be able to join
- Subject males or females 18 to 70 years old
- Subject able and willing to follow study procedures and instructions
- Subject read, understood and signed an informed consent form
- Subject diagnosed with type II diabetes
- Currently under standard treatment and physicians care for diabetes control
- Standard diabetes medication has not changed in the last 3 months
- HbA1c levels of ≥ 6.5% determined upon medical record review within the last 6 months (if HbA1c value not available in medical record or if patient is new, the first study visit value will determine if patient may continue in the study)
Who cannot join
- Subject with concomitant periodontal therapy 6 months prior to enrollment
- Subject with orthodontic appliances
- Subject chronically treated (i.e., two weeks or more) with any medication known to affect inflammation or periodontal status or (e.g.phenytoin, cyclosporine, Coumadin or steroids) within one month of the first examination*
- Subject currently smoke or who report smoking within one year of first examination ≥ 10 cigarettes/day
- Subject treated with antibiotics within 3 months prior to enrollment
- Subject necessitating antibiotic prophylaxis
Show all 12Show fewer
- Female subject who report being pregnant or lactating at first appointment
- Subject uses hormonal contraceptives but started method less than 30 days prior to the first examination
- Subject with active infectious diseases (hepatitis, human immunodeficiency virus or Tuberculosis) or subject is immunocompromised as determined by the Investigator
- Subjects has a medical condition which precludes not eating/drinking for approximately 8 hours
- Subject has serious diabetic complications such as macrovascular diseases or kidney or liver failure
- Subjects who have a known allergy to oral care products or ingredients in oral care products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Periodontal Treatment on Gingival Inflammatory Response of the Type II Diabetic Patient
Diabetes mellitus affects > 171 million people worldwide, with type II diabetes being the most prevalent, affecting 85-95% of the diabetic population. Unfortunately, despite conventional medical treatment, some diabetic patients do not seem to be able to reach desirable metabolic control. This is a double-blinded, randomized study investigating the effects of triclosan containing toothpaste (commercial name: Colgate Total) on the response to periodontal treatment in type II diabetic patients with periodontal disease. The investigators believe that using triclosan containing toothpaste during periodontal treatment will decrease the local inflammatory response and that this reduction will improve periodontal status and metabolic control.
Read the detailed description
Many studies have shown a relationship between chronic inflammatory periodontal diseases and diabetes, in which both diseases influence the other. Research studies have shown that controlling inflammation of the gums can improve the level of metabolic control (i.e. blood glucose levels) in patients with diabetes. However, it is still not clear which periodontal treatment approach would best maintain the control of inflammation of diabetic patients. Triclosan has anti-plaque and anti-inflammatory properties and decreases gum inflammation. The purpose of this study is to 1) determine the effects of triclosan containing toothpaste on gum inflammation in type II diabetic patients with periodontal disease, and 2) to evaluate whether type II diabetic patients will show improvement in periodontal status and blood glucose following periodontal treatment with and without the use of a triclosan containing toothpaste.
Patients with type II diabetes that meet the study criteria will be randomly assigned either triclosan containing toothpaste or placebo toothpaste. Dental cleanings and oral exams will be performed at baseline, 6 weeks, 3, 6, 9 and 12 months, and samples will be collected at baseline, 3, 6 and 12 months. Samples that may be collected include blood, plaque, gingival crevicular fluid, saliva and plaque. Women may also be asked to complete a pregnancy test. Photographs and x-rays of the patients mouth/teeth may be taken, but is not a requirement.
The samples collected will be used to assess the effect of triclosan containing toothpaste on glycemic control and local and systemic inflammatory mediators during the course of periodontal treatment.
- Conditions
- Type II Diabetes, Periodontal Disease
- Being tested
- Triclosan containing toothpaste, Non-triclosan containing toothpaste
- Keywords
- Type II Diabetes, Periodontal Disease, Periodontitis, Gum Disease, Gingivitis, Triclosan, Inflammatory Markers, Immune Response
- Medical subject headings
- Diabetes Mellitus, Type 2, Periodontal Diseases, Periodontitis, Gingival Diseases, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triclosan containing toothpasteDrug
Also called Colgate Total
Type II diabetic patients will be instructed to brush their teeth at the same time day and with the same frequency as usual for them using only the triclosan containing toothpaste provided to them. Additional tubes of triclosan containing toothpaste will be provided to the participants for the duration of the study as needed. Following their baseline appointment, patients will be asked to return at 6 weeks, 3, 6, 9 and 12 months for an oral exam and dental cleaning. Samples will be collected at baseline, 3, 6 and 12 months. Samples collected may include venous blood, gingival crevicular fluid, plaque and saliva. Female study participants may be asked to perform a pregnancy test.
Non-triclosan containing toothpasteDrug
Also called Colgate
Type II diabetic patients will be instructed to brush their teeth at the same time day and with the same frequency as usual for them using only the non-triclosan containing toothpaste (i.e. placebo) provided to them. Additional tubes of non-triclosan containing toothpaste will be provided to the participants for the duration of the study as needed. Following their baseline appointment, patients will be asked to return at 6 weeks, 3, 6, 9 and 12 months for an oral exam and dental cleaning. Samples will be collected at baseline, 3, 6 and 12 months. Samples collected may include venous blood, gingival crevicular fluid, plaque and saliva. Female study participants may be asked to perform a pregnancy test.
| Study group | Role | What they receive |
|---|---|---|
| Triclosan containing toothpaste | Patients with type II diabetes will receive triclosan containing toothpaste and will be asked to brush their teeth using only this toothpaste for the duration of the study (12 months). Patients will be asked to return for an oral exam, dental cleaning and sample collection for up to 12 months following their baseline appointment. Receives: Drug: Triclosan containing toothpaste | |
| Non-triclosan containing toothpaste | Patients with type II diabetes will receive non-triclosan containing toothpaste and will be asked to brush their teeth using only this toothpaste for the duration of the study (12 months). Patients will be asked to return for an oral exam, dental cleaning and sample collection for up to 12 months following their baseline appointment. Receives: Drug: Non-triclosan containing toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Periodontal Parameters
The changes in clinical parameters(i.e. pocket depth, plaque, clinical attachment loss) during periodontal treatment from baseline to 3 months, 6 months and 12 months. Clinical parameters will be assessed using a conventional periodontal probe and recorded in supporting software (Florida Probe).
Measured: Baseline, 3, 6 and 12 months
Local Inflammatory Markers
The changes in local inflammatory markers (i.e. cytokines, chemokines, metalloproteinases) during periodontal treatment from baseline to 3 months, 6 months and 12 months. Local inflammatory markers in gingival crevicular fluid will be assayed in the laboratory.
Measured: Baseline, 3, 6 and 12 months
Secondary outcomes (2)
Glycemic Control
The changes in glycemic control (i.e. HbA1C levels) during periodontal treatment from baseline to 3 months, 6 months and 12 months. Blood will be analyzed by the core lab facility at the University of Florida and Shands hospital and in the clinic/laboratory using a commercially available finger prick device and testing strips.
Measured: Baseline, 3, 6 and 12 months
Systemic Inflammatory Markers
The changes in systemic inflammatory markers (i.e. cytokines, chemokines, metalloproteinases) during periodontal treatment from baseline to 3 months, 6 months and 12 months of periodontal treatment. Inflammatory markers in venous blood will be assayed in the laboratory.
Measured: Baseline, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Sponsor
- Investigators
- Luciana M Shaddox, DDS, MS, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881074
- Sponsor's protocol ID
- 287-2011
- Other IDs
- CRO-2011-PERIO-01-FP
- Status last verified
- Sep 2018
- First submitted
- 14 Jun 2013
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Tokatlian J, Al-Sabbagh M, Dawson DR, Pearce KA, Andriankaja MO, Adatorwovor R, Miguel MMV, Shaddox LM. The impact of periodontal therapy on clinical and inflammatory parameters in type II diabetics. J Periodontol. 2026 May;97(5):960-972. doi: 10.1002/jper.70035. Epub 2026 Jan 19.
PubMed 41553854
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Periodontal Treatment on Gingival Inflammatory Response of the Type II Diabetic Patient
- ClinicalTrials.gov ID
- NCT01881074
- Acronym / sponsor ID
- 287-2011
- Conditions
- Type II Diabetes, Periodontal Disease
- Keywords
- Type II Diabetes, Periodontal Disease, Periodontitis, Gum Disease, Gingivitis, Triclosan, Inflammatory Markers, Immune Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Jun 2013 (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 mellitus affects > 171 million people worldwide, with type II diabetes being the most prevalent, affecting 85-95% of the diabetic population. Unfortunately, despite conventional medical treatment, some diabetic patients do not seem to be able to reach desirable metabolic control. This is a double-blinded, randomized study investigating the effects of triclosan containing toothpaste (commercial name: Colgate Total) on the response to periodontal treatment in type II diabetic patients with periodontal disease. The investigators believe that using triclosan containing toothpaste during periodontal treatment will decrease the local inflammatory response and that this reduction will improve periodontal status and metabolic control.
Detailed description
Many studies have shown a relationship between chronic inflammatory periodontal diseases and diabetes, in which both diseases influence the other. Research studies have shown that controlling inflammation of the gums can improve the level of metabolic control (i.e. blood glucose levels) in patients with diabetes. However, it is still not clear which periodontal treatment approach would best maintain the control of inflammation of diabetic patients. Triclosan has anti-plaque and anti-inflammatory properties and decreases gum inflammation. The purpose of this study is to 1) determine the effects of triclosan containing toothpaste on gum inflammation in type II diabetic patients with periodontal disease, and 2) to evaluate whether type II diabetic patients will show improvement in periodontal status and blood glucose following periodontal treatment with and without the use of a triclosan containing toothpaste.
Patients with type II diabetes that meet the study criteria will be randomly assigned either triclosan containing toothpaste or placebo toothpaste. Dental cleanings and oral exams will be performed at baseline, 6 weeks, 3, 6, 9 and 12 months, and samples will be collected at baseline, 3, 6 and 12 months. Samples that may be collected include blood, plaque, gingival crevicular fluid, saliva and plaque. Women may also be asked to complete a pregnancy test. Photographs and x-rays of the patients mouth/teeth may be taken, but is not a requirement.
The samples collected will be used to assess the effect of triclosan containing toothpaste on glycemic control and local and systemic inflammatory mediators during the course of periodontal treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triclosan containing toothpaste | – | Drug: Triclosan containing toothpastePatients with type II diabetes will receive triclosan containing toothpaste and will be asked to brush their teeth using only this toothpaste for the duration of the study (12 months). Patients will be asked to return for an oral exam, dental cleaning and sample collection for up to 12 months following their baseline appointment. |
| Non-triclosan containing toothpaste | – | Drug: Non-triclosan containing toothpastePatients with type II diabetes will receive non-triclosan containing toothpaste and will be asked to brush their teeth using only this toothpaste for the duration of the study (12 months). Patients will be asked to return for an oral exam, dental cleaning and sample collection for up to 12 months following their baseline appointment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type II diabetic patients with periodontal disease requiring periodontal treatment.
Key inclusion criteria (7 listed)
- Subject males or females 18 to 70 years old
- Subject able and willing to follow study procedures and instructions
- Subject read, understood and signed an informed consent form
- Subject diagnosed with type II diabetes
- Currently under standard treatment and physicians care for diabetes control
Key exclusion criteria (12 listed)
- Subject with concomitant periodontal therapy 6 months prior to enrollment
- Subject with orthodontic appliances
- Subject chronically treated (i.e., two weeks or more) with any medication known to affect inflammation or periodontal status or (e.g.phenytoin, cyclosporine, Coumadin or steroids) within one month of the first examination*
- Subject currently smoke or who report smoking within one year of first examination ≥ 10 cigarettes/day
- Subject treated with antibiotics within 3 months prior to enrollment
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 |
|---|---|---|
| Triclosan containing toothpasteAlso: Colgate TotalType II diabetic patients will be instructed to brush their teeth at the same time day and with the same frequency as usual for them using only the triclosan containing toothpaste provided to them. Additional tubes of triclosan containing toothpaste will be provided to the participants for the duration of the study as needed. Following their baseline appointment, patients will be asked to return at 6 weeks, 3, 6, 9 and 12 months for an oral exam and dental cleaning. Samples will be collected at baseline, 3, 6 and 12 months. Samples collected may include venous blood, gingival crevicular fluid, plaque and saliva. Female study participants may be asked to perform a pregnancy test. | Drug | Triclosan containing toothpaste |
| Non-triclosan containing toothpasteAlso: ColgateType II diabetic patients will be instructed to brush their teeth at the same time day and with the same frequency as usual for them using only the non-triclosan containing toothpaste (i.e. placebo) provided to them. Additional tubes of non-triclosan containing toothpaste will be provided to the participants for the duration of the study as needed. Following their baseline appointment, patients will be asked to return at 6 weeks, 3, 6, 9 and 12 months for an oral exam and dental cleaning. Samples will be collected at baseline, 3, 6 and 12 months. Samples collected may include venous blood, gingival crevicular fluid, plaque and saliva. Female study participants may be asked to perform a pregnancy test. | Drug | Non-triclosan containing toothpaste |
Primary outcome
Clinical Periodontal Parameters
Time frame: Baseline, 3, 6 and 12 months
The changes in clinical parameters(i.e. pocket depth, plaque, clinical attachment loss) during periodontal treatment from baseline to 3 months, 6 months and 12 months. Clinical parameters will be assessed using a conventional periodontal probe and recorded in supporting software (Florida Probe).
Local Inflammatory Markers
Time frame: Baseline, 3, 6 and 12 months
The changes in local inflammatory markers (i.e. cytokines, chemokines, metalloproteinases) during periodontal treatment from baseline to 3 months, 6 months and 12 months. Local inflammatory markers in gingival crevicular fluid will be assayed in the laboratory.
2 secondary outcomes
Glycemic Control
Time frame: Baseline, 3, 6 and 12 months
Systemic Inflammatory Markers
Time frame: Baseline, 3, 6 and 12 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 17 Sep 2018.
- Derived from this study: PubMed 41553854Tokatlian J, Al-Sabbagh M, Dawson DR, Pearce KA, Andriankaja MO, Adatorwovor R, Miguel MMV, Shaddox LM. The impact of periodontal therapy on clinical and inflammatory parameters in type II diabetics. J Periodontol. 2026 May;97(5):960-972. doi: 10.1002/jper.70035. Epub 2026 Jan 19.
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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.
Luciana M Shaddox, DDS, MS, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type II Diabetes and Periodontal Disease, run by University of Florida 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 7 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 17 Sep 2018. 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?
Clinical Periodontal Parameters (time frame: Baseline, 3, 6 and 12 months). The study lists 2 primary outcomes in all. 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 NCT01881074, which also lists 1 linked publication.
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 17 Sep 2018.