K05.3
Conditions
Interventions
Group 1: Participants receive standard non-surgical periodontal therapy (scaling and root planing) together with a probiotic supplement (GUM® PerioBalance®, Sunstar Deutschland GmbH, Schönau, Germany)
Sponsors
Universitätsklinikum Heidelberg, Abteilung für Zahnerhaltungskunde
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosed periodontitis, localized or generalized, stage III or IV Scheduled for systematic periodontal therapy Ability to give informed consent and signed informed consent form Agreement with data protection regulations
Exclusion criteria
Exclusion criteria: Age < 18 years Missing consent or lack of agreement with data protection Cognitive impairment or inability to give informed consent Known systemic disease affecting the oral microbiome (e.g. diabetes mellitus) Pregnancy or breastfeeding Periodontitis as a manifestation of a systemic disease Requirement for adjunctive antibiotic therapy during periodontal treatment (e.g. endocarditis risk, immunosuppression, prior head-neck irradiation) Bleeding tendency or current anticoagulant therapy Use of corticosteroids or immunosuppressive medication Use of calcium channel blockers Severe systemic or infectious disease (e.g. HIV) Acute infections Alcohol or drug abuse Subgingival instrumentation within the last 6 months Antibiotic use within the last 3 months Intake of pro- or prebiotics within the last 3 months Participation in another dental study involving mechanical or drug therapy within the last 6 months Regular use of antiseptic mouth rinses Strict dietary regimes (e.g. vegan or ketogenic diet) Chronic inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the composition and relative abundance of microbial species in the oral microbiome (supragingival and subgingival) between baseline and three months after therapy, assessed by 16S rDNA and metagenomic sequencing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in clinical periodontal parameters: probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), gingival bleeding index (GBI), plaque control record (PCR). • Change in overall oral health status (DMFT index). • Change in nutritional quality assessed by validated questionnaires (DEGS and MEDAS). • Change in perceived stress level assessed by the Perceived Stress Scale (PSS). • Change in level of physical activity assessed by the International Physical Activity Questionnaire (IPAQ). • Demographic, socioeconomic, and health-related background data collected via structured questionnaires and anamnesis. | — |
Countries
Germany
Contacts
Public ContactDiana Wolff
Universitätsklinikum Heidelberg
Outcome results
None listed