Periodontal Treatment Response in Type II Diabetic Patients
The Influence of Periodontal Treatment on Gingival Inflammatory Response of the Type II Diabetic Patient
2 other identifiers
observational
74
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 14, 2013
CompletedFirst Posted
Study publicly available on registry
June 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 17, 2018
September 1, 2018
3.5 years
June 14, 2013
September 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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.
Baseline, 3, 6 and 12 months
Secondary Outcomes (2)
Glycemic Control
Baseline, 3, 6 and 12 months
Systemic Inflammatory Markers
Baseline, 3, 6 and 12 months
Study Arms (2)
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.
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.
Interventions
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.
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.
Eligibility Criteria
Type II diabetic patients with periodontal disease requiring periodontal treatment.
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Colgate Palmolivecollaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32610, United States
Related Publications (1)
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 Jan 19. doi: 10.1002/jper.70035. Online ahead of print.
PMID: 41553854DERIVED
Biospecimen
blood, gingival crevicular fluid, and saliva
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luciana M Shaddox, DDS, MS, PhD
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2013
First Posted
June 19, 2013
Study Start
June 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
September 17, 2018
Record last verified: 2018-09