search
Back to results

Perio Treatment & Cerebrovascular Function

Primary Purpose

Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
periodontal treatment
Sponsored by
University of Santiago de Compostela
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Santiago de CompostelaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Periodontal treatment group

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pulsatility index
Gosling's pulsatility index (PI) of the middle cerebral artery will be calculated according to the following formula: PI = (Vmax -Vmin)/Vmean
Resistivity index
Resistivity index (RI) of the middle cerebral artery will be calculated according to the following formula: RI = (Vmax -Vmin)/Vmax
Serum high sensitivity C-reactive protein (hs-CRP)
Levels of hs-CRP in serum will be measured by ELISA (mg/L)
Brachial flow-mediated dilatation
After detection of brachial artery vasomotion, ultrasound evaluation will be made on the dominant forearm. Two- dimensional brachial artery imaging and measurements were performed in all patients by the same operator. Straight segments of the artery will be chosen above the antecubital fosse, perpendicular to the ultrasound beam and along its long axis. Flow-mediated dilatation caused by shear-induced endothelial nitric oxide production will be detected after occlusion of the forearm circulation. A longitudinal image will be used to measure brachial artery diameter; a blood pressure cuff will be inflated on the upper arm to 300 mmHg for 4 min and then deflated, and after 45 s to 1 min, a second longitudinal scan will be obtained, to calculate the brachial artery diameter.
Carotid intima-media thickness
The image will be focused on the posterior (far) wall of the left carotid artery. A minimum of four measurements of the common carotid far wall was taken 10 mm proximal to the bifurcation, to derive the mean carotid intima-media thickness. The presence of an atheroma plaque will be evaluated in the common and internal carotid extracranial arteries as well as the bifurcations according to standardized scanning and reading protocols. Plaque will be defined as a focal structure that encroaches into the arterial lumen at least 0.5 mm or 50% of the surrounding intima-media thickness value, or demonstrates a thickness >1.5 mm as measured from the media-adventitia interface to the intima- lumen interface.
Probing pocket depth
Will be measured from the free gingival margin to the bottom of the sulcus or pocket (in mm)
Clinical attachment level
measured from the cemento-enamel junction (CEJ) to the bottom of the sulcus or pocket (in mm)
Full-mouth bleeding score
Defined as the number of sites with gingival bleeding on probing (BoP) divided by the total number of sites per mouth, multiplied by 100 (%)
Full-mouth plaque score
Defined as the number of sites with detectable supragingival dental plaque divided by the total number of sites per mouth, multiplied by 100 (%)

Full Information

First Posted
August 12, 2022
Last Updated
August 18, 2022
Sponsor
University of Santiago de Compostela
search

1. Study Identification

Unique Protocol Identification Number
NCT05506917
Brief Title
Perio Treatment & Cerebrovascular Function
Official Title
Impact of Periodontal Treatment on Brain Hemodynamics
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santiago de Compostela

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pre-post comparison study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Periodontal treatment group
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
periodontal treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cerebrovascular reactivity (CvR) (%)
Description
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).
Time Frame
Baseline-6 months
Secondary Outcome Measure Information:
Title
Pulsatility index
Description
Gosling's pulsatility index (PI) of the middle cerebral artery will be calculated according to the following formula: PI = (Vmax -Vmin)/Vmean
Time Frame
Baseline-6 months
Title
Resistivity index
Description
Resistivity index (RI) of the middle cerebral artery will be calculated according to the following formula: RI = (Vmax -Vmin)/Vmax
Time Frame
Baseline-6 months
Title
Serum high sensitivity C-reactive protein (hs-CRP)
Description
Levels of hs-CRP in serum will be measured by ELISA (mg/L)
Time Frame
Baseline-6 months
Title
Brachial flow-mediated dilatation
Description
After detection of brachial artery vasomotion, ultrasound evaluation will be made on the dominant forearm. Two- dimensional brachial artery imaging and measurements were performed in all patients by the same operator. Straight segments of the artery will be chosen above the antecubital fosse, perpendicular to the ultrasound beam and along its long axis. Flow-mediated dilatation caused by shear-induced endothelial nitric oxide production will be detected after occlusion of the forearm circulation. A longitudinal image will be used to measure brachial artery diameter; a blood pressure cuff will be inflated on the upper arm to 300 mmHg for 4 min and then deflated, and after 45 s to 1 min, a second longitudinal scan will be obtained, to calculate the brachial artery diameter.
Time Frame
Baseline-6 months
Title
Carotid intima-media thickness
Description
The image will be focused on the posterior (far) wall of the left carotid artery. A minimum of four measurements of the common carotid far wall was taken 10 mm proximal to the bifurcation, to derive the mean carotid intima-media thickness. The presence of an atheroma plaque will be evaluated in the common and internal carotid extracranial arteries as well as the bifurcations according to standardized scanning and reading protocols. Plaque will be defined as a focal structure that encroaches into the arterial lumen at least 0.5 mm or 50% of the surrounding intima-media thickness value, or demonstrates a thickness >1.5 mm as measured from the media-adventitia interface to the intima- lumen interface.
Time Frame
Baseline-6 months
Title
Probing pocket depth
Description
Will be measured from the free gingival margin to the bottom of the sulcus or pocket (in mm)
Time Frame
Baseline-3 months-6 months
Title
Clinical attachment level
Description
measured from the cemento-enamel junction (CEJ) to the bottom of the sulcus or pocket (in mm)
Time Frame
Baseline-3 months-6 months
Title
Full-mouth bleeding score
Description
Defined as the number of sites with gingival bleeding on probing (BoP) divided by the total number of sites per mouth, multiplied by 100 (%)
Time Frame
Baseline-3 months-6 months
Title
Full-mouth plaque score
Description
Defined as the number of sites with detectable supragingival dental plaque divided by the total number of sites per mouth, multiplied by 100 (%)
Time Frame
Baseline-3 months-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yago Leira, PhD
Phone
881812415
Email
yagoleira@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
María Vázquez, DDS
Phone
881812415
Email
mariavazquezreza@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yago Leira, PhD
Organizational Affiliation
University of Santiago de Compostela
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Santiago de Compostela
City
Santiago De Compostela
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yago Leira, PhD
Email
yagoleira@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Vazquez, DDS
Email
mariavazquezreza@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
only upon request to PI

Learn more about this trial

Perio Treatment & Cerebrovascular Function

We'll reach out to this number within 24 hrs