Periodontal DiseasePhase 3NCT00763256

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

A Phase 3 study testing Triclosan, Fluoride and Fluoride in people with Periodontal Disease, run by Colgate Palmolive at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To test effectiveness of dentifrice in maintaining periodontal health. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Periodontal Disease
What is being tested?: Triclosan, Fluoride and Fluoride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 1 siteAustralia
Study dates: May 2006to Aug 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Australia1 site

Logan Hospital Oral Health Clinic
Queensland

Other trials in Australia

About this study

To test effectiveness of dentifrice in maintaining periodontal health.

Conditions: Periodontal Disease
Being tested: Triclosan, Fluoride, Fluoride
Medical subject headings: Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Triclosan, FluorideDrug
Also called triclosan/fluoride/copolymer toothpaste
subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.
FluorideDrug
Also called current marketed fluoride only toothpaste
subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.

Study groups in NCT00763256
Study group	Role	What they receive
A	Active comparator	Not described Receives: Drug: Triclosan, Fluoride
B	Placebo comparator	Not described Receives: Drug: Fluoride

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1c Levels in Blood
Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
Measured: 12 months
High Sensitivity CRP (C-Reactive Protein)
CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
Measured: 12 months
C-Peptide
C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
Measured: 12 months
Gingivitis Score (GI)
Units on a scale 0 to 3 (0 = no inflammation,
1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Measured: 12 months
P. Gingivalis
Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Aug 2009

First posted30 Sep 2008 (estimated)
Study startMay 2006
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
More trials run by Colgate PalmoliveThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00763256
Sponsor's protocol ID: 2004000841/2004/201
Status last verified: Jul 2015
First submitted: 26 Sep 2008
Last updated: 28 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel

All Periodontal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
ClinicalTrials.gov ID: NCT00763256
Acronym / sponsor ID: 2004000841/2004/201
Conditions: Periodontal Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Colgate PalmoliveIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 2 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To test effectiveness of dentifrice in maintaining periodontal health.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: Triclosan, Fluoride
B	Placebo comparator	Drug: Fluoride

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Triclosan, FluorideAlso: triclosan/fluoride/copolymer toothpastesubjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.	Drug	A
FluorideAlso: current marketed fluoride only toothpastesubjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.	Drug	B

Primary outcome

HbA1c Levels in Blood
Time frame: 12 months
Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
High Sensitivity CRP (C-Reactive Protein)
Time frame: 12 months
CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
C-Peptide
Time frame: 12 months
C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
Gingivitis Score (GI)
Time frame: 12 months
Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
P. Gingivalis
Time frame: 12 months
Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation.

Results and safety

Results posted to the registry on 2 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Comparator	15	8
B - Placebo Comparator	18	8

Primary outcome: HbA1c Levels in Blood

Time frame: 12 months. Mean (Standard Deviation). Unit: Percentage

Measure	Active Comparator n = 15	B - Placebo Comparator n = 18
Value	9.47 (2.2)	10.27 (2.4)

Active Comparator vs B - Placebo Comparator: p = 0.05, t-test, 2 sided

Primary outcome: High Sensitivity CRP (C-Reactive Protein)

Time frame: 12 months. Mean (Standard Deviation). Unit: mg/L

Measure	Active Comparator n = 15	B - Placebo Comparator n = 18
Value	6.16 (5.5)	5.37 (3.8)

Active Comparator vs B - Placebo Comparator: p = 0.05, t-test, 2 sided

Primary outcome: C-Peptide

Time frame: 12 months. Mean (Standard Deviation). Unit: nmol/L

Measure	Active Comparator n = 15	B - Placebo Comparator n = 18
Value	1.20 (1.0)	1.04 (0.6)

Active Comparator vs B - Placebo Comparator: p = 0.05, t-test, 2 sided

Primary outcome: Gingivitis Score (GI)

Time frame: 12 months. Mean (Standard Deviation). Unit: Units on a scale

Measure	Active Comparator n = 15	B - Placebo Comparator n = 18
Value	0.89 (0.2)	0.88 (0.1)

Active Comparator vs B - Placebo Comparator: p = 0.05, t-test, 2 sided

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Comparator	0 of 15 (0%)	0 of 15 (0%)	Not reported
B - Placebo Comparator	0 of 18 (0%)	0 of 18 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Periodontal Disease

Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregory Seymour, BDS principal investigator

University of Otago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Triclosan, Fluoride and Fluoride in people with Periodontal Disease, run by Colgate Palmolive at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c Levels in Blood (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00763256.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.