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Trial · NCT04954313

Outcomes16

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYImpact of Treatment on Change in Oral Health MeasuresComparing T1 (day 90) and T4 (day 360)Data include imputation. Predictions based on linear mixed models were used for imputation.millimeters (probing depth difference)LEAST_SQUARES_MEAN
PRIMARYAssociation Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c)Comparing T0 (day 0) and T4 (day 360)
Analysis population includes only participants meeting the following criteria: (1) HbA1c data was available at T0 and T4 time points, (2) probing depth data was available at T0 and T4 time points, and (3) screening HbA1c \>= 5.7 (if screening value was not available, T0 value of HbA1c \>= 5.7 was used as proxy).
Pearson correlation coefficientNUMBER
PRIMARYAssociation Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation)Comparing T0 (day 0) and T4 (day 360)
Analysis population includes only participants meeting the following criteria: (1) flow mediated dilation data was available at T0 and T4 time points, (2) probing depth data was available at T0 and T4 time points.
Pearson correlation coefficientNUMBER
SECONDARYChange in Emotional WellbeingComparing T0 (day 0) and T4 (day 360)Analysis population includes only participants who completed the survey at T0 and T4 time points.scores on a scaleMEAN
SECONDARYChange in Beliefs About Periodontal DiseaseComparing T0 (day 0) and T4 (day 360)Analysis population includes only participants who completed the survey at T0 and T4 time points.scores on a scaleMEAN
SECONDARYChange in Bleeding on ProbingComparing T0 (day 0) and T4 (day 360)Analysis population includes only participants who received dental assessment at T0 and T4 time points.scores on a scaleMEAN
SECONDARYChange in Gingival IndexComparing T0 (day 0) and T4 (day 360)Analysis population includes only participants who received dental assessment at T0 and T4 time points.scores on a scaleMEAN
SECONDARYPercent Change in Clinical Attachment Level (CAL)Comparing T0 (day 0) and T4 (day 360)Analysis population includes only participants who received dental assessment at T0 and T4 time points.% changeMEAN
SECONDARYChange in Dental Plaque IndexComparing T0 (day 0) and T4 (day 360)Analysis population includes only participants who received dental assessment at T0 and T4 time points.scores on a scaleMEAN
SECONDARYChange in Flow-mediated DilationComparing T0 (day 0) and T4 (day 360)
Some participants did not have FMD measured at T0 and/or T4 and are not included in the T4-T0 comparison. Missing data arises from a combination of participant withdrawal/loss to followup and poor ultrasound data quality.
% changeMEAN
SECONDARYPercent Change in Glycated Hemoglobin (HbA1c) (Prediabetic and Type 2 Diabetic Cohorts)Comparing T0 (day 0) and T4 (day 360)
Analysis population includes only participants meeting the following criteria: (1) biomarker data was available at T0 and T4 time points and (2) screening HbA1c \>= 5.7 (if screening value was not available, T0 value of HbA1c \>= 5.7 was used as proxy).
% changeMEAN
SECONDARYPercent Change in Carotid Intima Media Thickness (IMT)Comparing T0 (day 0) and T4 (day 360)
Some participants are missing measurement data at either T0 or T4 timepoints, precluding calculation of T0 to T4 percent change. Missing data arises from a combination of participant withdrawal/loss to followup and poor ultrasound data quality.
% changeMEAN
SECONDARYPercent Change of High Sensitivity C-reactive Protein (Hs-CRP)Comparing T0 (day 0) and T4 (day 360)Analysis population includes only participants for whom biomarker data was available at T0 and T4 time points.% changeMEAN
SECONDARYPercent Change in Total CholesterolComparing T0 (day 0) and T4 (day 360)Analysis population includes only participants for whom biomarker data was available at T0 and T4 time points.% changeMEAN
SECONDARYPercent Change in Low Density Lipoprotein (LDL) CholesterolComparing T0 (day 0) and T4 (day 360)Analysis population includes only participants for whom biomarker data was available at T0 and T4 time points.% changeMEAN
SECONDARYPercent Change in TriglyceridesComparing T0 (day 0) and T4 (day 360)Analysis population includes only participants for whom biomarker data was available at T0 and T4 time points.% changeMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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