Perio Treatment & Cerebrovascular Function

Periodontitis Clinical Trial

Official title:

Impact of Periodontal Treatment on Brain Hemodynamics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506917
• Other study ID #: PT-01
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: September 2023

Study information

• Verified date: August 2022
• Source: University of Santiago de Compostela
• Contact: Yago Leira, PhD
• Phone: 881812415
• Email: yagoleira[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Spain	University of Santiago de Compostela	Santiago De Compostela

Sponsors (1)

Lead Sponsor	Collaborator
University of Santiago de Compostela

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pulsatility index	Gosling's pulsatility index (PI) of the middle cerebral artery will be calculated according to the following formula: PI = (Vmax -Vmin)/Vmean	Baseline-6 months
Secondary	Resistivity index	Resistivity index (RI) of the middle cerebral artery will be calculated according to the following formula: RI = (Vmax -Vmin)/Vmax	Baseline-6 months
Secondary	Serum high sensitivity C-reactive protein (hs-CRP)	Levels of hs-CRP in serum will be measured by ELISA (mg/L)	Baseline-6 months
Secondary	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.	Baseline-6 months
Secondary	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.	Baseline-6 months
Secondary	Probing pocket depth	Will be measured from the free gingival margin to the bottom of the sulcus or pocket (in mm)	Baseline-3 months-6 months
Secondary	Clinical attachment level	measured from the cemento-enamel junction (CEJ) to the bottom of the sulcus or pocket (in mm)	Baseline-3 months-6 months
Secondary	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 (%)	Baseline-3 months-6 months
Secondary	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 (%)	Baseline-3 months-6 months