The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics

NCT ID: NCT00763256

Last Updated: 2015-07-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To test effectiveness of dentifrice in maintaining periodontal health.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type ACTIVE_COMPARATOR

Triclosan, Fluoride

Intervention Type DRUG

subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.

B

Group Type PLACEBO_COMPARATOR

Fluoride

Intervention Type DRUG

subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Triclosan, Fluoride

subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.

Intervention Type DRUG

Fluoride

subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

triclosan/fluoride/copolymer toothpaste current marketed fluoride only toothpaste

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gregory Seymour, BDS

Role: PRINCIPAL_INVESTIGATOR

University of Otago

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Logan Hospital Oral Health Clinic

Queensland, , Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004000841/2004/201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clinical Study to Evaluate Dental Plaque
NCT00758290 COMPLETED PHASE3
Anti-gingivitis Mouthrinse
NCT06048627 COMPLETED PHASE3