Phase 3
N=33
The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
Periodontal Disease
Bottom Line
View on ClinicalTrials.gov: NCT00763256 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: HbA1c Levels in Blood — 9.47; 10.27 Percentage — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Triclosan, Fluoride (Drug); Fluoride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Levels in Blood |
9.47; 10.27 | 0.05 |
| PRIMARY High Sensitivity CRP (C-Reactive Protein) |
6.16; 5.37 | 0.05 |
| PRIMARY C-Peptide |
1.20; 1.04 | 0.05 |
| PRIMARY Gingivitis Score (GI) |
0.89; 0.88 | 0.05 |
| PRIMARY P. Gingivalis |
209; 22 | 0.05 |
Summary
To test effectiveness of dentifrice in maintaining periodontal health.
Eligibility Criteria
Inclusion Criteria
- Poor glycaemic control as evidenced by an HbA1c of >6.0% for the past 12 months
- Aged 18 to 75 years
- Able to give informed consent
- Minimum of 12 teeth
- Chronic periodontitis as indicated by periodontal probing depths >5mm on at least 6 teeth
Exclusion Criteria
- Pregnancy
- Gross dental caries
- Prosthetic heart valves, a history of infective endocarditis or any other condition requiring antibiotic cover for dental treatment (rheumatic fever, mitral valve prolapse with regurgitation)
- Anticoagulant therapy (excluding asprin)
Data sourced from ClinicalTrials.gov (NCT00763256). 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.