Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atherosclerotic Plaque Responsible for Ischemic Stroke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Cardiovascular disease is the world's leading cause of death. Atherothrombosis is a common cause of ischemic stroke.

A strong epidemiological link has been established between periodontitis and the risk of stroke. It shares common risk factors with atherothrombosis, and its severe form is associated with low-grade systemic inflammation and daily low-intensity bacteremia. Atherothrombosis is a frequent cause of ischemic stroke.

Periodontal bacteria have been found within atheromatous plaques, correlated with a greater risk of rupture.

Thus, periodontitis could be a modifiable risk factor for atherothrombosis and future vascular events: its early diagnosis and treatment could have a major impact on cardiovascular prevention.

Hypothesis: In patients with periodontitis who have had an ischemic stroke, periodontal treatment may reduce atherosclerotic plaque activity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Minor ischemic stroke of the anterior circulation (NIHSS ≤ 5) of atherothrombotic origin according to the TOAST scale <30 days

Atheroma plaque of the ipsilateral carotid bulb >30% not eligible for intervention (endarterectomy or angioplasty-stenting)

Severe periodontitis (stage 3 or 4)

Disqualifiers

< 6 teeth

Without independent oral hygiene

Contraindications to PET scan

Known allergy to fluoro-deoxyglucose and its excipient

Trial design

Design model

Parallel

Treatments tested in this trial

  • periodontal treatment strategy

    Procedure/Surgery

    Periodontal treatment sessions (Experimental Group only) (1 to 3 months) after randomization

Treatment groups

157 Participants
are divided into 2 treatment groups
Group A: Group with periodontal treatment strategyExperimental treatment 1 intervention
Group B: Group without periodontal treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold).

The evolution of the metabolic activity of the atherosclerotic plaque measured by the Target-to-Background ratio (TBR) measured by PET scan after injection of 18-FDG at 6 months versus at baseline in percentage evolution (relative evolution) and in number of patients for whom the TBR becomes \<1.6 (threshold).

Time frame
At 6 months
2

Number of patients with Target-to-Background (TBR) becomes <1.6 (threshold).

The evolution of the metabolic activity of the atherosclerotic plaque measured by the Target-to-Background ratio (TBR) measured by PET scan after injection of 18-FDG at 6 months versus at baseline in percentage evolution (relative evolution) and in number of patients for whom the TBR becomes \<1.6 (threshold).

Time frame
At 6 months

Secondary outcomes

1

Absolute change on Target-to-Background (TBR) ratio

Nominal change in atherosclerotic plaque metabolic activity measured by Target-to-Background (TBR) ratio measured by PET scan after 18-FDG injection at 6 months versus at baseline (absolute change).

Time frame
At 6 months
2

Proportion of TBR success becomes <1.6

Time frame
At 6 months
3

cardiovascular event

Time frame
At 12 months
4

ischemic stroke

Time frame
At 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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