I25 K05.4
Conditions
Interventions
Group 1: Early Intervention (Intervention Arm). Participants with diagnosed periodontitis, based on findings obtained within the study, who are assigned to the early intervention arm, receive a standa
Sponsors
GRN-Klinikum Weinheim
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Presence of a clinical indication for cardiac CT imaging due to suspected coronary artery disease (CAD) or suspected progression of known CAD, manifested by symptoms such as stable angina pectoris or exertional dyspnea, as well as documented recent dental care, defined as regular check-ups by a primary dentist within the past two years.
Exclusion criteria
Exclusion criteria: Ongoing periodontal treatment, lack of regular dental care, inability to provide informed consent, and current pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint comprises two complementary components designed to assess the impact of periodontal therapy on the progression of coronary atherosclerosis as well as on systemic inflammatory and cardiac stress markers. First, the change in coronary plaque burden on cardiac CT between baseline and the defined follow-up time point will be evaluated. Particular emphasis is placed on non-calcified and mixed plaque components, as these are considered highly relevant to cardiovascular risk. The comparison between the intervention and control groups aims to determine whether systematic periodontal therapy influences the progression of coronary atherosclerosis. Second, the change in concentrations of cardiac biomarkers (hs-CRP, hs-TnT, NT-proBNP) between baseline (prior to initiation of periodontal treatment) and the 24-month follow-up will be assessed. For each biomarker, the intra-individual difference (? = follow-up – baseline) will be calculated. These delta values will be compared between study arms to quantify the effect of periodontal therapy on systemic inflammation and cardiac stress. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints encompass a broad range of periodontal, systemic, and cardiovascular parameters to comprehensively assess the effects of periodontal therapy. These include changes in key clinical periodontal measures such as probing depths, clinical attachment level, bleeding on probing, and overall periodontal inflammatory status, which quantify the therapeutic response and allow correlations with systemic and cardiac developments. In addition, systemic inflammatory and laboratory parameters are evaluated to characterize potential inflammatory interaction mechanisms linking periodontal inflammation, systemic inflammation, and cardiovascular risk. The clinical symptomatology of coronary artery disease is likewise documented, particularly stable angina pectoris and exertional dyspnea, in order to capture functional consequences of potential structural or biochemical changes. Finally, detailed analyses of coronary plaque characteristics on cardiac CT—including plaque morphology, composition, and potential high-risk features—are performed to determine whether periodontal therapy induces qualitative modifications in plaque structure. | — |
Countries
Germany
Contacts
Public ContactGrigorios Korosoglou
GRN-Klinikum Weinheim
Outcome results
None listed