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Trial · NCT03191721

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryClinical Attachment Level (CAL) at 24 months.24 monthsDifference between groups for the change in Clinical Attachment Level (CAL) from baseline to 24 months.
SecondaryProbing Depth (PD) ≥ 5 mm.Baseline, 3, 6, 12, 18, 24 months.Number of sites with Probing Depth (PD) ≥ 5 mm, evaluated in all volunteers.
SecondaryPD ≥ 6 mm.Baseline, 3, 6, 12, 18, 24 months.Number of sites with PD ≥ 6 mm, evaluated in all volunteers.
SecondaryPD ≥ 7 mm.Baseline, 3, 6, 12, 18, 24 months.Number of sites with PD ≥ 7 mm, evaluated in all volunteers.
SecondaryFull-mouth PD.Baseline, 3, 6, 12, 18, 24 months.Mean of the PD evaluated in all the periodontal sites from all volunteers.
SecondaryFull-mouth CAL.Baseline, 3, 6, 12, 18, 24 months.Mean of the CAL evaluated in all the periodontal sites from all volunteers.
SecondaryBleeding on Probing (BOP).Baseline, 3, 6, 12, 18, 24 months.Percentage of sites with bleeding on probing (BOP), evaluated in all volunteers.
SecondaryPlaque accumulation.Baseline, 3, 6, 12, 18, 24 months.Percentage of sites with plaque accumulation, evaluated in all volunteers.
SecondaryMarginal bleeding.Baseline, 3, 6, 12, 18, 24 months.Percentage of sites with marginal bleeding.
SecondarySites gaining CAL ≥ 2mm.Baseline - 24 months.Percentage of sites gaining ≥ 2mm of CAL.
SecondarySites loosing CAL ≥ 2mmBaseline - 24 months.Percentage of sites loosing ≥ 2mm of CAL
SecondaryRadiographic Bone HeightBaseline, 3, 6, 12, 18, 24 months.Mean values of radiographic bone height
SecondaryBOP reductionBaseline - 24 months.Reduction in the percentage of sites exhibiting BOP.
SecondaryAdverse effects3, 6, 12, 18, 24 months.Occurrence of nausea and irritability obtained through a questionnaire of adverse effects
SecondaryProportions of periodontal pathogenic bacterial species.Baseline, 3, 6, 12, 18, 24 months.Proportions of periodontal pathogenic bacterial species in subgingival biofilm samples.
SecondaryCounts of periodontal pathogenic bacterial species.Baseline, 3, 6, 12, 18, 24 months.Proportions of periodontal pathogenic bacterial species in subgingival biofilm samples.

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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