PeriodontitisNCT05506917
Perio Treatment & Cerebrovascular Function
A study testing periodontal treatment in people with Periodontitis, run by University of Santiago de Compostela at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jul 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Otherwise healthy subjects with severe periodontitis.
Who cannot join
- <10 teeth
- current smokers
- undergo periodontal treatment within the last 6 months.
- receive antibiotics or anti-inflammatory drugs within the last 3 months.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Santiago de Compostela
Santiago de Compostela
Yago Leira, PhD, yagoleira@gmail.com
Maria Vazquez, DDS, mariavazquezreza@gmail.com
About this study
Official title: Impact of Periodontal Treatment on Brain Hemodynamics
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
- Being tested
- periodontal treatment
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline-6 months
Secondary outcomes (9)
Pulsatility index
Gosling's pulsatility index (PI) of the middle cerebral artery will be calculated according to the following formula: PI = (Vmax -Vmin)/Vmean
Measured: Baseline-6 months
Resistivity index
Resistivity index (RI) of the middle cerebral artery will be calculated according to the following formula: RI = (Vmax -Vmin)/Vmax
Measured: Baseline-6 months
Serum high sensitivity C-reactive protein (hs-CRP)
Levels of hs-CRP in serum will be measured by ELISA (mg/L)
Measured: Baseline-6 months
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.
Measured: Baseline-6 months
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.
Measured: Baseline-6 months
Probing pocket depth
Will be measured from the free gingival margin to the bottom of the sulcus or pocket (in mm)
Measured: Baseline-3 months-6 months
Clinical attachment level
measured from the cemento-enamel junction (CEJ) to the bottom of the sulcus or pocket (in mm)
Measured: Baseline-3 months-6 months
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 (%)
Measured: Baseline-3 months-6 months
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 (%)
Measured: Baseline-3 months-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start12 Jul 2022
- Primary completionApr 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pre-post comparison study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yago Leira Feijoo, University of Santiago de Compostela
- Investigators
- Yago Leira, PhD, Principal investigator, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506917
- Sponsor's protocol ID
- PT-01
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only upon request to PI
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Periodontal Treatment on Brain Hemodynamics
- ClinicalTrials.gov ID
- NCT05506917
- Acronym / sponsor ID
- PT-01
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre-post comparison study
| Arm | Type | Receives |
|---|---|---|
| Periodontal treatment group | Experimental | Procedure: periodontal treatmentPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Otherwise healthy subjects with severe periodontitis.
Key exclusion criteria (4 listed)
- <10 teeth
- current smokers
- undergo periodontal treatment within the last 6 months.
- receive antibiotics or anti-inflammatory drugs within the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| periodontal treatmentPatients 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 or surgery | Periodontal treatment group |
Primary outcome
Cerebrovascular reactivity (CvR) (%)
Time frame: Baseline-6 months
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).
9 secondary outcomes
Pulsatility index
Time frame: Baseline-6 months
Resistivity index
Time frame: Baseline-6 months
Serum high sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline-6 months
Brachial flow-mediated dilatation
Time frame: Baseline-6 months
Carotid intima-media thickness
Time frame: Baseline-6 months
Probing pocket depth
Time frame: Baseline-3 months-6 months
Clinical attachment level
Time frame: Baseline-3 months-6 months
Full-mouth bleeding score
Time frame: Baseline-3 months-6 months
Full-mouth plaque score
Time frame: Baseline-3 months-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No. only upon request to PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yago Leira, PhD principal investigator
University of Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal treatment in people with Periodontitis, run by University of Santiago de Compostela at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yago Leira, PhD (881812415, yagoleira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular reactivity (CvR) (%) (time frame: Baseline-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.