Periodontal Treatment and Ischemic Stroke

NCT04956211 | Unknown

• 1 other identifier: NP1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A bulk of observational evidence suggests an association between periodontitis and recurrent vascular events in ischemic stroke survivors. One plausible biological mechanism relies on the systemic inflammatory response posed by periodontitis together with changes in the normal function of the vascular endothelium which might lead to recurrence in these population. A non-pharmacological anti-inflammatory treatment (non-surgical periodontal therapy) has shown to reduce systemic inflammatory markers and improve endothelial function. Therefore, we propose to carry out a 1-year follow-up pilot randomized controlled clinical trial to investigate whether control of local and systemic inflammation as well as improve function of the vascular endothelium can lead to reduce the risk of recurrence in patients diagnosed from ischemic stroke.

Conditions

Stroke, Ischemic; Periodontitis

Keywords

endothelium; inflammation; recurrence

Outcome Measures

Primary Outcomes (1)

• IL-6 serum levels

  Concentrations of IL-6 in serum will be measured by ELISA technique

  from baseline to 6 months after therapy

Secondary Outcomes (8)

• Other inflammatory markers

  from baseline to 6 months after therapy

• Flow-mediated dilatation (brachial artery)

  from baseline to 6 months after therapy

• Intima-media thickness (carotid artery)

  from baseline to 6 months after therapy

• Recurrent vascular events

  from baseline to 12 months after therapy

• Lipid fractions

  from baseline to 6 months after therapy

Study Arms (2)

Non-surgical periodontal therapy

EXPERIMENTAL

Oral hygiene instructions will be given to all individuals. Any hopeless tooth or categorised as irrational to treat at baseline visit will be extracted at the treatment visit(s). Patients will receive a standard regimen of scaling and root planing of the root surfaces under local analgesia (depending on the severity in one or two sessions within 2 days) with curettes and ultrasonic instruments .

Procedure: Periodontal therapy

Conventional periodontal therapy

ACTIVE COMPARATOR

Oral hygiene instructions will be given to all individuals. Any hopeless tooth or categorised as irrational to treat at baseline visit will be extracted at the treatment visit(s). Supragingival cleaning and polishing of all dentition will be delivered to individuals in this group.

Procedure: Periodontal therapy

Interventions

Periodontal therapy PROCEDURE

Patients will receive a standard regimen of scaling and root planing of the root surfaces under local analgesia (depending on the severity in one or two sessions within 2 days) with curettes and ultrasonic instruments.

Conventional periodontal therapy; Non-surgical periodontal therapy

Eligibility Criteria

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

You may qualify if:

• Aged \>18 years old.
• Non-severely disabling initial ischemic stroke (mRS≤3) in the last 90 days.
• With diagnosis of severe periodontitis (generalized stage III-IV).
• Presence of at least 10 teeth in the mouth.

You may not qualify if:

• Patients receiving periodontal treatment in the last 12 months.
• Stroke due to intracranial hemorrhage, dissection, veno-occlusive disease, drugs, trauma or vasculitis.
• Previous neurological impairment that would make detection of a subsequent event difficult.
• Comorbidities that may limit survival \<12 months.
• Brain CT/MRI that shows a lesion other than stroke as a cause of syndrome.
• History of medical conditions requiring antibiotic prophylaxis prior to dental exam.
• Pregnants or breastfeeding.
• Known allergy or hypersensitivity to local anesthesia thst cannot be medically managed.
• Patients with bleeding disorders or

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

University of Santiago de Compostela

Santiago de Compostela, A Coruña, 15782, Spain

Location

Related Publications (1)

• Ye Z, Cao Y, Miao C, Liu W, Dong L, Lv Z, Iheozor-Ejiofor Z, Li C. Periodontal therapy for primary or secondary prevention of cardiovascular disease in people with periodontitis. Cochrane Database Syst Rev. 2022 Oct 4;10(10):CD009197. doi: 10.1002/14651858.CD009197.pub5.

  PMID: 36194420 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Periodontitis; Inflammation; Recurrence

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Yago Leira, PhD

  Health Research Institute of Santiago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 9, 2021
• Study Start: September 29, 2021
• Primary Completion: November 11, 2022
• Study Completion: December 29, 2023
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)