K05.3
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed stage II or III periodontitis according to the current classification of periodontal diseases • Presence of gingival inflammation defined as bleeding on probing (BOP) > 30% • At least 14 remaining teeth • An approximately balanced distribution of male and female participants will be aimed for
Exclusion criteria
Exclusion criteria: Periodontal therapy within the previous two years prior to study inclusion • Antibiotic therapy within the previous six months • Current intake of probiotic supplements • Current use of non-steroidal anti-inflammatory drugs (NSAIDs) • Presence of severe systemic diseases, particularly • malignant diseases • severe chronic infectious diseases (e.g., HIV) • Patients requiring infective endocarditis prophylaxis • Smoking prevalence exceeding 10% of study participants • Fructose intolerance • Strict vegetarian or vegan diet • Refusal to consume fish • Known food allergies or intolerances that would substantially limit adherence to the dietary intervention; participation may be considered on an individual basis after consultation with the study nutrition team • Exceptions: gluten intolerance and lactose intolerance, provided that the dietary intervention can be adapted accordingly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in periodontal inflammation measured as the proportion of sites with bleeding on probing (BOP, %) between baseline (BL) and three months after completion of non-surgical periodontal therapy (3M). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the number and proportion of residual periodontal pockets requiring further treatment, defined as probing depth (PD) >4 mm with bleeding on probing (BOP+), between baseline (BL) and three months (3M). • Change in the number and proportion of periodontal pockets with surgical treatment indication, defined as probing depth (PD) >5 mm, between baseline (BL) and three months (3M). Description of the composition and longitudinal changes of the oral and gut microbiome between baseline (BL) and three months (3M). • Description of cytokine profiles and their changes between baseline (BL) and three months (3M). • Changes in gingival inflammation and plaque accumulation, assessed by Gingival Index (GI) and Plaque Index (PI), over the observation period between baseline (BL) and three months (3M), including comparison with a pre-treatment time point prior to therapy initiation (PBL). • Changes in plasma levels of selected micronutrients, including vitamin D, vitamin C, zinc, and B vitamins, between baseline (BL) and three months (3M). • Changes in mean probing depth (PD) and mean clinical attachment level (CAL) between baseline (BL) and three months (3M). • Patient adherence to the dietary intervention, assessed during the three-month intervention period and during an additional two-month follow-up period without further dietary counseling. • Change in body weight during the study period. | — |
Countries
Germany
Contacts
Uniklinik Heidelberg