Perio Treatment & Cerebrovascular Function

NCT ID: NCT05506917

Last Updated: 2022-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-12

Study Completion Date

2023-09-30

Brief Summary

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Periodontitis has been linked to increased risk of cerebrovascular disease. Impaired brain hemodynamics has been suggested as early markers of cerebral macro and microangiopathy. Therefore, the aim of this clinical trial will be to assess the potential effect of periodontal treatment on cerebral hemodynamics in otherwise healthy patients with severe periodontitis over 6 months.

Detailed Description

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Conditions

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Periodontitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

pre-post comparison study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Periodontal treatment group

Patients will receive an intensive (non surgical) regimen of scaling and root planing of the root surfaces under local analgesia (depending on the severity in one session or two sessions within 2 days). Any tooth that from the baseline examination is defined as hopeless or irrational to treat will be extracted at the oral hygiene visit. After the 2 months re-assessment individuals if presenting with at least one periodontal pocket of 6 mm in depth will undergo additional corrective periodontal therapy consisting of periodontal surgery and re-instrumentation under local analgesia. If surgical periodontal therapy is not indicated, appropriate re-instrumentation of the sites will be performed.

Group Type EXPERIMENTAL

periodontal treatment

Intervention Type PROCEDURE

Patients will receive an intensive (non surgical) regimen of scaling and root planing of the root surfaces under local analgesia (depending on the severity in one session or two sessions within 2 days). Any tooth that from the baseline examination is defined as hopeless or irrational to treat will be extracted at the oral hygiene visit. After the 2 months re-assessment individuals if presenting with at least one periodontal pocket of 6 mm in depth will undergo additional corrective periodontal therapy consisting of periodontal surgery and re-instrumentation under local analgesia. If surgical periodontal therapy is not indicated, appropriate re-instrumentation of the sites will be performed.

Interventions

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periodontal treatment

Patients will receive an intensive (non surgical) regimen of scaling and root planing of the root surfaces under local analgesia (depending on the severity in one session or two sessions within 2 days). Any tooth that from the baseline examination is defined as hopeless or irrational to treat will be extracted at the oral hygiene visit. After the 2 months re-assessment individuals if presenting with at least one periodontal pocket of 6 mm in depth will undergo additional corrective periodontal therapy consisting of periodontal surgery and re-instrumentation under local analgesia. If surgical periodontal therapy is not indicated, appropriate re-instrumentation of the sites will be performed.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Otherwise healthy subjects with severe periodontitis.

Exclusion Criteria

* \<10 teeth
* current smokers
* undergo periodontal treatment within the last 6 months.
* receive antibiotics or anti-inflammatory drugs within the last 3 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Santiago de Compostela

OTHER

Sponsor Role lead

Responsible Party

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Yago Leira Feijoo

Postoctoral resseacher and clinical supervisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yago Leira, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Santiago de Compostela

Locations

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University of Santiago de Compostela

Santiago de Compostela, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Yago Leira, PhD

Role: CONTACT

881812415

María Vázquez, DDS

Role: CONTACT

881812415

Facility Contacts

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Yago Leira, PhD

Role: primary

Maria Vazquez, DDS

Role: backup

Other Identifiers

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PT-01

Identifier Type: -

Identifier Source: org_study_id

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