EFFECT OF PERIODONTAL TREATMENT ON ALZHEIMER DISEASE-ASSOCIATED OUTCOMES

NCT07233512 | Enrolling By Invitation DMC

• 1 other identifier: B7072021000057
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alzheimer's disease; periodontitis; neuroinflammation; randomized controlled trial; cognitive function

Outcome Measures

Primary Outcomes (1)

• Cognitive status using pre-clinical Alzheimer cognitive composite (PACC)

  The Preclinical Alzheimer Cognitive Composite (PACC) is a sensitive neuropsychological tool designed to detect subtle cognitive decline in the early stages of Alzheimer's disease (AD). It combines several tests assessing memory, executive function, and global cognition, including the Free and Cued Selective Reminding Test (FCSRT), Logical Memory delayed recall, Digit Symbol Substitution Test, and Mini-Mental State Examination. Each test score is standardized into z-scores and averaged to produce a composite reflecting global cognition. The PACC is validated as a primary outcome measure in AD prevention trials, showing strong correlations with amyloid and tau biomarkers, and enabling early detection of cognitive decline before dementia onset.

  From enrollment to the end of the study at 24 months for the test group. And from 6 months until the end of the study at 24 months

Study Arms (3)

TEST GROUP

EXPERIMENTAL

Test group: 35 patients diagnosed with both mild to moderate stage of AD and periodontal disease.This group will receive immediatly complete periodontal treatment: an initial periodontal therapy (step 1 and 2) along with any needed dental extractions, and with an intensive supportive periodontal care follow-up (every 3 months). At 12 months from baseline, patients will receive an additional periodontal surgical therapy (step 3 of periodontal therapy). and/or an intensive supportive periodontal care (SPC) follow-up every 3 months (step 4)

Procedure: INITIAL PERIODONTAL THERAPY

CONTROL GROUP

ACTIVE COMPARATOR

o Control group: 35 patients diagnosed with both mild to moderate stage of AD and periodontal disease. This group will receive a delayed periodontal therapy (step 1, 2, and 3 ) 6 months after the test group along with a regular supportive periodontal care follow-up (every 6 months). At 12 months from baseline, patients will receive an additional periodontal surgical therapy (step 3 of periodontal therapy) and/or an intensive supportive periodontal care (SPC) follow-up every 3 months (step 4)

Procedure: INITIAL PERIODONTAL THERAPY

COMMON GROUP

EXPERIMENTAL

At the 12-month mark, all participants-regardless of initial group allocation-will be merged into a single cohort. At this stage, additional periodontal surgical therapy (Step 3) will be administered, followed by intensified supportive periodontal care (Step 4), consisting of maintenance visits every 3 months for the remainder of the study period.

Procedure: INITIAL PERIODONTAL THERAPY

Interventions

INITIAL PERIODONTAL THERAPY PROCEDURE

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.

Also known as: HOPELESS TOOTH EXTRACTION, ADDITIONAL PERIODONTAL SURGICAL THERAPY

COMMON GROUP; CONTROL GROUP; TEST GROUP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have to suffer from AD
• Must agree to have brain imaging (without contra-indication for MRI)
• Possess a minimum of 10 residual teeth
• Have an MMSE score greater than 15
• Exhibit a DPSI score of ≥ 3+ indicating advanced periodontal disease

You may not qualify if:

• Participation in another clinical trial (30 days)
• Contra-indication for MRI
• Use of antibiotics in the past 3 months
• Immunosuppressive drugs or chemotherapy

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead
• Eklund foundation Malmö: collaborator

Study Sites (1)

CHU de Liège, Université de Liège Domaine du Sart Tilman

Liège, 4000, Belgium

Location

Related Publications (15)

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MeSH Terms

Conditions

Alzheimer Disease; Periodontitis; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontist - Oral surgeon

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 17, 2023
• Primary Completion (Estimated): September 10, 2029
• Study Completion (Estimated): September 10, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

BE (1)