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Trial · NCT01976806

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryChange in Pocket Depth (mm)Baseline and 3 months
Pocket probing depth (PD) is the depth a dental probe can be inserted into a gingival pocket at a particular site (6 sites per tooth) measured in millimeters among teeth with PD greater than or equal to 5 mm (N=533 dental sites total).
SecondaryChange in Gingival Index (0-3)Baseline and 3 months
Gingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3). Score Criteria: 0: No inflammation. 1. Mild inflammation, slight change in color, slight edema, no bleeding on probing. 2. Moderate inflammation, moderate glazing, redness, bleeding on probing. 3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.
SecondaryChange in Plaque Index (0-3)Baseline and 3 months
Plaque Index (PI) is a measure of gingival inflammation as induced by bacterial plaque deposition at and under the gum line. Score Criteria: 0: No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can not be seen with the naked eye. But only by using disclosing solution or by using probe. 2. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
SecondarySites With Bleeding on Probing (Yes/no)3 monthsBleeding On Probing (BOP) is a measure of gingival inflammation and tissue destruction, which describes whether or not bleeding at the dental pocket occurred following probing.
SecondaryGingival Crevicular Fluid High Sensitivity C-reactive ProteinBaseline and 3 monthsGingival crevicular fluid (GCF) is the fluid bathing the teeth under the gum line. GCF samples were analyzed for high sensitivity C-reactive protein as a measure of local gingival inflammation.
SecondaryGingival Crevicular Fluid Interleukin-6Baseline and 3 monthsGingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.
SecondaryGingival Crevicular Fluid Interleukin-1 BetaBaseline and 3 monthsGingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.
SecondarySerum High-sensitivity C-reactive ProteinBaseline and 3 monthsSerum high-sensitivity C-reactive protein is a measure of systemic inflammation.
SecondarySerum High-sensitivity Interleukin-6Baseline and 3 monthsSerum high-sensitivity interleukin-6 is a measure of systemic inflammation.
SecondarySerum Soluble Vascular Cell Adhesion MoleculeBaseline and 3 monthsSerum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.
SecondaryUrine N-Terminal TelopeptidesBaseline and 3 monthsUrine N-Terminal Telopeptides are a measure of systemic bone turnover.
OtherChange in Red Blood Cell Membrane Docosahexaenoic AcidBaseline and 3 monthsRed blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence.

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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