Phase 3
N=60
Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population
Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT00762762 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: HbA1c Levels in Blood — 11.42; 10.81 percentage of HbA1c levels in blood — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Triclosan/copolymer/fluoride (Drug); Fluoride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Levels in Blood |
11.42; 10.81 | 0.05 |
| PRIMARY High Sensitivity CRP (C-Reactive Protein) |
14.94; 10.76 | 0.05 |
| PRIMARY C-Peptide |
5.39; 4.61 | 0.05 |
| PRIMARY IL-6 (Interleukin - 6) |
1.93; 2.89 | 0.05 |
| PRIMARY TNF-α (Tumor Necrosis Factor - Alpha) |
4.13; 3.50 | 0.05 |
Summary
Clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2 diabetic population.
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes with poor glycaemic control as evidenced by random blood glucose of >200mg/dl.
- Minimum of 16 teeth
- Chronic periodontitis as indicated by periodontal probing depths >4mm on at least 6 teeth
Exclusion Criteria
- Any condition requiring antibiotic cover for dental treatment
- Other serious illness
Data sourced from ClinicalTrials.gov (NCT00762762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.