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Trial · NCT00763256

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

NCT00763256, Phase 3, Completed, Colgate Palmolive; results first posted 2012-04-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics. Trials, record NCT00763256. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00763256

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
NCT number
NCT00763256
Status
Completed
Phases
Phase 3
Enrollment
33 participants, actual
Lead sponsor
Colgate Palmolive
Conditions
Periodontal Disease
Interventions
Triclosan, Fluoride, Fluoride
First posted
2008-09-30
Last updated
2015-07-28
Results first posted
2012-04-02

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryHbA1c Levels in Blood12 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).
PrimaryHigh Sensitivity CRP (C-Reactive Protein)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).
PrimaryC-Peptide12 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).
PrimaryGingivitis Score (GI)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)
PrimaryP. Gingivalis12 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.

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYHbA1c Levels in Blood12 monthsPercentageMEAN
PRIMARYHigh Sensitivity CRP (C-Reactive Protein)12 monthsmg/LMEAN
PRIMARYC-Peptide12 monthsnmol/LMEAN
PRIMARYGingivitis Score (GI)12 monthsUnits on a scaleMEAN
PRIMARYP. Gingivalis12 monthsPg/ng DNAMEDIAN

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
HbA1c Levels in BloodActive Comparator9.47Standard Deviation 2.2Percentage
HbA1c Levels in BloodB - Placebo Comparator10.27Standard Deviation 2.4Percentage
High Sensitivity CRP (C-Reactive Protein)Active Comparator6.16Standard Deviation 5.5mg/L
High Sensitivity CRP (C-Reactive Protein)B - Placebo Comparator5.37Standard Deviation 3.8mg/L
C-PeptideActive Comparator1.20Standard Deviation 1.0nmol/L
C-PeptideB - Placebo Comparator1.04Standard Deviation 0.6nmol/L
Gingivitis Score (GI)Active Comparator0.89Standard Deviation 0.2Units on a scale
Gingivitis Score (GI)B - Placebo Comparator0.88Standard Deviation 0.1Units on a scale
P. GingivalisActive Comparator209Inter-Quartile Range 0 to 23688Pg/ng DNA
P. GingivalisB - Placebo Comparator22Inter-Quartile Range 0 to 15982Pg/ng DNA

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDActive Comparator15
Overall StudySTARTEDB - Placebo Comparator18
Overall StudyCOMPLETEDActive Comparator8
Overall StudyCOMPLETEDB - Placebo Comparator8
Overall StudyNOT COMPLETEDActive Comparator7
Overall StudyNOT COMPLETEDB - Placebo Comparator10

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityActive Comparator
Total, all-cause mortalityB - Placebo Comparator
Total, other adverse eventsActive Comparator015
Total, other adverse eventsB - Placebo Comparator018
Total, serious adverse eventsActive Comparator015
Total, serious adverse eventsB - Placebo Comparator018

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Active Comparator vs B - Placebo Comparator: serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00763256

GET https://conductscience.org/api/trials/v1/NCT00763256/registered