Perio Treatment & Cerebrovascular Function

NCT05506917 | Unknown

• 1 other identifier: PT-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Cerebrovascular reactivity (CvR) (%)

  CvR to hypercapnia was evaluated by means of the breath-holding index (BHI). Two dual 2-MHz transducers fitted on a headband and placed on the temporal bone windows were used to obtain a bilateral continuous measurement of mean flow velocity in the middle cerebral arteries. Depth of insonation ranged from 48 to 52 mm. The BHI is obtained by dividing the percentage increase in mean flow velocity occurring during breath holding by the length of time (seconds) subjects hold their breath af- ter a normal inspiration (\[mean flow velocity at the end of breath holding minus mean flow velocity at rest divided by mean flow velocity at rest\] multipled by 100 divided by seconds of breath holding).

  Baseline-6 months

Secondary Outcomes (9)

• Pulsatility index

  Baseline-6 months

• Resistivity index

  Baseline-6 months

• Serum high sensitivity C-reactive protein (hs-CRP)

  Baseline-6 months

• Brachial flow-mediated dilatation

  Baseline-6 months

• Carotid intima-media thickness

  Baseline-6 months

Study Arms (1)

Periodontal treatment group

EXPERIMENTAL

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.

Procedure: periodontal treatment

Interventions

periodontal treatment 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.

Periodontal treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Otherwise healthy subjects with severe periodontitis.

You may not qualify if:

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

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

University of Santiago de Compostela

Santiago de Compostela, Spain

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Study Officials

• Yago Leira, PhD

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yago Leira, PhD

CONTACT

881812415; yagoleira@gmail.com

María Vázquez, DDS

CONTACT

881812415; mariavazquezreza@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postoctoral resseacher and clinical supervisor

Model Details: pre-post comparison study

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 18, 2022
• Study Start: July 12, 2022
• Primary Completion: April 1, 2023
• Study Completion: September 1, 2023
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)