EFFECT OF PERIODONTAL TREATMENT ON ALZHEIMER DISEASE-ASSOCIATED OUTCOMES
NCT07233512 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2025-11-18
Summary
Periodontitis is the most prevalent chronic infectious inflammatory disease in adults, leading to the destruction of tooth-supporting tissues. Beyond its local impact, periodontitis contributes to systemic inflammation through the release of periodontal pathogens and their byproducts into the bloodstream. Given that chronic intracerebral inflammation is a known driver of Alzheimer's disease (AD) progression, a biological link between the two conditions has been hypothesized. This study aims to evaluate whether periodontal treatment can influence AD progression by reducing systemic inflammation. We have designed a randomized controlled clinical trial including 70 patients diagnosed with both AD and stage 3 or 4 periodontitis, randomly allocated to receive either immediate (test group) or delayed (control group) periodontal therapy. All participants will undergo comprehensive periodontal treatment and be followed over a 24-month period. Cognitive assessments, periodontal evaluations, blood and saliva biomarker analyses, and neuroimaging will be conducted at multiple time points to assess the potential impact of periodontal therapy on AD progression. This trial represents the first clinical investigation into the effect of periodontal treatment on the course of Alzheimer's disease.
Conditions
- Alzheimers Disease
- Periodontitis
Interventions
- PROCEDURE
-
INITIAL PERIODONTAL THERAPY
The intervention will be an initial periodontal therapy (step 1 and 2). Instrumentation will be performed by two calibrated periodontists (Y.A. \& L.S) using an ultrasonic piezoelectric device with specific micro-inserts (Newtron P5 XS Bled, Acteon, Satelec, France). Local subgingival disinfection will be performed using hydrogen peroxide and povidone iodine 1%. The patients will be trained to maintain good personal oral hygiene, including interdental hygiene (floss, brushes) and water for chemical plaque control containing 0.2% chlorhexidine, 3 - 4 weeks twice a day. This initial periodontal therapy will be carried out at different time points depending on the group (test group and control group).The initial periodontal therapy also include extractions of hopeless teeth. A clinical reevaluation will be conducted three months after completion of the initial periodontal therapy in the test group, and twelve months after baseline in the control group.
Sponsors & Collaborators
-
Eklund foundation Malmö
collaborator UNKNOWN -
Centre Hospitalier Universitaire de Liege
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-17
- Primary Completion
- 2029-09-10
- Completion
- 2029-09-10
Countries
- Belgium
Study Locations
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