Periodontitis
Conditions
Brief summary
Absolute change from baseline (V2) to week 24 (V4) in the number of residual PPD ≥ 5mm.
Detailed description
Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the mean probing pocket depth (PPD)., Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the mean clinical attachment level (CAL)., Absolute change from baseline (V2) to week 12 (V3) and week 24 (V4) in the number of residual PPD ≥ 4mm, Absolute change from baseline (V2) to week 12 (V3) in the number of residual PPD ≥ 5mm., Absolute change from baseline (V2) to week 12 (V3) and week 24 (V4) in the number of residual PPD ≥ 6mm, Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the bleeding on probing (BoP), Absolute change from baseline to week 12 (V3) and 24 (V4) on the plaque control (O’Leary), Percentage of participants with ≤4 sites with PPD ≥ 5mm at week 24 (V4), Absolute change from baseline (V1) to week 12 (V3) and 24 (V4) in the 25(OH)D3 serum concentration., Percentage of participants reaching 25(OH)D3 serum concentrations superior to 30 ng/ml at week 24 (V4)., Incidence in adverse events including adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs)., Change from baseline in laboratory data including the assessment of serum concentration of calcium and phosphate throughout the clinical trial.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline (V2) to week 24 (V4) in the number of residual PPD ≥ 5mm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the mean probing pocket depth (PPD)., Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the mean clinical attachment level (CAL)., Absolute change from baseline (V2) to week 12 (V3) and week 24 (V4) in the number of residual PPD ≥ 4mm, Absolute change from baseline (V2) to week 12 (V3) in the number of residual PPD ≥ 5mm., Absolute change from baseline (V2) to week 12 (V3) and week 24 (V4) in the number of residual PPD ≥ 6mm, Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the bleeding on probing (BoP), Absolute change from baseline to week 12 (V3) and 24 (V4) on the plaque control (O’Leary), Percentage of participants with ≤4 sites with PPD ≥ 5mm at week 24 (V4), Absolute change from baseline (V1) to week 12 (V3) and 24 (V4) in the 25(OH)D3 serum concentration., Percentage of participants reaching 25(OH)D3 serum concentrations superior to 30 ng/ml at week 24 (V4)., Incidence in adverse | — |
Countries
Belgium