Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in Probable pocket depth (PPD) |
distance between the gingival margin and pocket base (mm); full-mouth scores, 6 sites per tooth |
baseline, 2nd, 6th, 12th and 24th weeks following therapy |
|
Primary |
Change in Bleeding on probing (BoP) |
visual inspection, dichotomous; full-mouth, 6 sites per tooth; change in positive sites % |
baseline, 2nd, 6th, 12th and 24th weeks following therapy |
|
Primary |
Baseline macrophage related cytokine concentrations in granulation tissue samples |
two pockets (=6mm; BoP+) of each individual; Luminex: monocyte chemoattractant protein (MCP)-1, -2, -3, -4; macrophage derived chemokine (MDC); macrophage inhibitory factor (MIF), monokine induced by gamma interferon (MIG), macrophage inflammatory protein (MIP)-1a, interferon ?-induced protein (IP)-10, CD163, TWEAK, BAFF concentrations (pg/mL); each will be correlated with the change in probable pocket depth and bleeding on probing scores |
Samples will be obtained during the intervention and will be kept in -80oC until immunohistochemical analysis which will be carried out through study completion, 6-9 months |
|
Primary |
Baseline Th17-pathway related cytokine concentrations in granulation tissue samples |
two pockets (=6mm; BoP+) of each individual; Luminex: Interleukin (IL)-1ß, -4, -6, -10, -17A, -17F, -21, -22, -23, -25, -31, -33, interferon (IFN)-?, soluble cluster of differentiation 40 ligand (sCD-40L), tumor necrosis factor (TNF)-? concentrations (pg/mL); each will be correlated with the change in probable pocket depth and bleeding on probing scores |
Samples will be obtained during the intervention and will be kept in -80oC until immunohistochemical analysis which will be carried out through study completion, 6-9 months |
|
Primary |
Baseline density of macrophage types in granulation tissue samples |
two pockets (=6mm; BoP+) from each individual; Immunoblot analysis: cluster of differentiation(CD)68 and CD163; cell number / optic field (cells/mm2); each will be correlated with the change in probable pocket depth and bleeding on probing scores |
Samples will be obtained during the intervention and will be kept in -80oC until immunohistochemical analysis which will be carried out through study completion, 6-9 months |
|
Secondary |
Change in macrophage and Th17-pathway related cytokine concentrations in saliva |
MCP-1, -2, -3, -4, MDC, MIF, MIG, MIP-1a, IP-10, IL1ß, -4, -6, -10, -17A, -17F, -21, -22, -23, -25, -31, -33, IFN-?, sCD-40L, TNF-?, sCD163, TWEAK, BAFF, sST2 concentrations (pg/mL); will be correlated with the change in probable pocket depth and bleeding on probing scores |
baseline, 2nd, 6th, 12th and 24th weeks following therapy; immunohistochemical analysis will be carried out through study completion, 6-9 months |
|
Secondary |
Change in macrophage and Th17-pathway related cytokine concentrations in gingival crevicular fluid (GCF) |
MCP-1, -2, -3, -4, MDC, MIF, MIG, MIP-1a, IP-10, IL1ß, -4, -6, -10, -17A, -17F, -21, -22, -23, -25, -31, -33, IFN-?, sCD-40L, TNF-?, sCD163, TWEAK, BAFF, sST2 concentrations (pg/mL); will be correlated with the change in probable pocket depth and bleeding on probing scores |
baseline, 2nd, 6th, 12th and 24th weeks following therapy; immunohistochemical analysis will be carried out when through study completion, 6-9 months |
|
Secondary |
Change in plaque index |
Silness-Löe plaque index (scored as 0-3); full-mouth, 6 sites per tooth; will be monitored for oral health assessment during the healing period |
baseline, 2nd, 6th, 12th and 24th weeks following therapy |
|
Secondary |
Change in clinical attachment level (CAL) |
distance between the cement-enamel junction and pocket base (mm); full-mouth, 6 sites per tooth; will be correlated with pocket depth reduction |
baseline, 2nd, 6th, 12th and 24th weeks following therapy |
|
Secondary |
Change in biofilm microbiota |
DNA isolation and next generation sequencing: P. gingivalis, T. denticola, T. forsythia, P. intermedia, F. nucleatum and A. actinomycetemcomitans; bacterial count (log10 scale) |
baseline, 2nd, 6th, 12th and 24th weeks following therapy; microbiological analysis will be carried out through clinical phase completion, 6-9 months |
|
Secondary |
Change in neutrophil-associated cytokines in saliva |
MMP-2, MMP-7, MMP-8, active MMP-8, MMP-9, MMP-13, TIMP, myeloperoxidase, PMN elastase (IFMA and ELISA methods) concentrations (pg/mL) in saliva |
baseline, 6th, 12th and 24th weeks following therapy |
|
Secondary |
Change in neutrophil-associated cytokines in and oral rinse |
MMP-2, MMP-7, MMP-8, active MMP-8, MMP-9, MMP-13, TIMP, myeloperoxidase, PMN elastase (IFMA and ELISA methods) concentrations (pg/mL) in oral rinse samples |
baseline, 6th, 12th and 24th weeks following therapy |
|
Secondary |
active MMP-8 point-of-care test results in oral rinse |
Dichotomous aMMP-8 test results in oral rinse samples (according to the manufacturer, a concentration below 20 ng/mL gives a negative test result, otherwise positive - Periosafe (R) Dentognostics GmHb, Jena, Germany) |
baseline, 6th, 12th and 24th weeks following therapy |
|