Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00762762




Registration number
NCT00762762
Ethics application status
Date submitted
26/09/2008
Date registered
30/09/2008
Date last updated
3/03/2023

Titles & IDs
Public title
Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population
Scientific title
The Effect of Periodontal Treatment and the Use of a Triclosan/Copolymer/Fluoride Toothpaste on Glycaemic Control in Diabetics.
Secondary ID [1] 0 0
2004000685
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Triclosan/copolymer/fluoride
Treatment: Drugs - Fluoride

Active comparator: Total toothpaste - Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste.

Placebo comparator: Fluoride mouthrinse - Swish whole mouth 2x/day for 12 months with fluoride mouthrinse.


Treatment: Drugs: Triclosan/copolymer/fluoride
Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.

Treatment: Drugs: Fluoride
Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c Levels in Blood
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
High Sensitivity CRP (C-Reactive Protein)
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
C-Peptide
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
IL-6 (Interleukin - 6)
Timepoint [4] 0 0
12 months
Primary outcome [5] 0 0
TNF-a (Tumor Necrosis Factor - Alpha)
Timepoint [5] 0 0
12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any condition requiring antibiotic cover for dental treatment
* Other serious illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Colgate Palmolive
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00762762
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Gregory Seymour, BDS, PhD
Address 0 0
Otago University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00762762