Acute-phase Response & Periodontal Treatment in Patients With Hypertension (PERIO-HYPERTEN)

November 3, 2020 updated by: Filippo Graziani, DDS MClinDent PhD, University of Pisa

Acute-phase Response & Periodontal Treatment in Patients With High Blood Pressure

The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical periodontal treatment in patients affected by periodontitis and high blood pressure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Periodontal treatment, consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), will be performed by a single periodontist on patients with periodontitis and hypertension.

The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical periodontal treatment in patients affected by periodontitis and high blood pressure.

Treatment will be provided using both hand and ultrasonic instrumentation with fine tips.

FM-SRP patients will received treatment within 24 h. Q-SRP patients will received four quadrants sessions of periodontal treatment with an interval of 1 week between sessions.

Vital, endothelial function and blood inflammatory parameters will be evaluated at baseline, 24 hours after the first treatment and after 3 months. Periodontal parameters will be evaluated at baseline and after 3 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy, 56121
        • University Hospital of Pisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients affected by Periodontal Disease
  • 20% of periodontal pockets of the entire dentition
  • 20% bleeding on probing of the entire dentition
  • Documented radiographic bone loss
  • Diagnosis of Hypertension as measured through international standards

Exclusion Criteria:

  • age younger than 18 years and older than 80 years
  • pregnant or lactating females
  • need of antibiotic coverage for periodontal treatment
  • treatment with statins and/or acetylsalicylic acid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Full mouth scaling and root planing
FM-SRP No surgical periodontal treatment will be performed in all dentition within 24 hours
Procedure: FM-SRP
Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.
Other Names:
  • Full mouth scaling and root planing
ACTIVE_COMPARATOR: Quadrant Scaling and Root Planing
Q-SRP No surgical periodontal treatment will be performed in all dentition subdivided in four appointments. Each appointment will be performed in one week interval. In each appointment only a "quadrant" of the dentition will be instrumented.
Procedure: Q-SRP
Supra- and sub-gingival mechanical instrumentation of the root surface will be performed in all dentition subdivided in four appointments. Each appointment will be performed in one week interval. In each appointment only a "quadrant" of the dentition will be instrumented.Performed in 3 weeks time frame.
Other Names:
  • Quadrant scaling and root planing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Levels C-Reactive Protein
Time Frame: Baseline, 24 hours and 3 months after treatment
Changes in C reactive protein (CRP). Unit of measure: mg/L
Baseline, 24 hours and 3 months after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Full Mouth Plaque Score (FMPS)
Time Frame: Baseline and 3 months after treatment
Changes in FMPS. Unit of Measure: %
Baseline and 3 months after treatment
Full Mouth Bleeding Score (FMBS)
Time Frame: Baseline and 3 months after treatment
Changes in FMBS. Unit of Measure: %
Baseline and 3 months after treatment
Triglycerides
Time Frame: Baseline, 24 hours and 3 months after treatment
Changes in triglycerides. Unit of measure: mmol/L
Baseline, 24 hours and 3 months after treatment
Low-density lipoprotein (LDL)
Time Frame: Baseline, 24 hours and 3 months after treatment
Changes in LDL. Unit of measure: mmol/L
Baseline, 24 hours and 3 months after treatment
High-density lipoprotein (HDL)
Time Frame: Baseline, 24 hours and 3 months after treatment
Changes in HDL. Unit of measure: mmol/L
Baseline, 24 hours and 3 months after treatment
Endothelial Function
Time Frame: Baseline, 24 hours and 3 months after treatment
Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: %
Baseline, 24 hours and 3 months after treatment
Pocket probing depth (PPD)
Time Frame: Baseline and 3 months after treatment
Changes in PPD. Unit of Measure: mm
Baseline and 3 months after treatment
Clinical attachment level (CAL)
Time Frame: Baseline and 3 months after treatment
Changes in CAL. Unit of Measure: mm
Baseline and 3 months after treatment
Recession of the gingival margin (REC)
Time Frame: Baseline and 3 months after treatment
Changes in REC. Unit of Measure: mm
Baseline and 3 months after treatment
Cholesterol
Time Frame: Baseline, 24 hours and 3 months after treatment
Changes in total cholesterol. Unit of measure: mmol/L
Baseline, 24 hours and 3 months after treatment
Glycaemia
Time Frame: Baseline, 24 hours and 3 months after treatment
Changes in blood glucose level; Unit of measure: mg/dL
Baseline, 24 hours and 3 months after treatment
Glycated Hemoglobin
Time Frame: Baseline and 3 months after treatment
Changes in Glycated Hemoglobin level; Unit of measure: mmol/mol
Baseline and 3 months after treatment
Insulin
Time Frame: Baseline, 24 hours and 3 months after treatment
Changes in Insulin level; Unit of measure: μU/mL
Baseline, 24 hours and 3 months after treatment
Systolic Blood Pressure (SBP)
Time Frame: Baseline, 24 hours and 3 months after treatment
Changes in SBP; Unit of measure: mmHg
Baseline, 24 hours and 3 months after treatment
Diastolic Blood Pressure (DBP)
Time Frame: Baseline, 24 hours and 3 months after treatment
Changes in DBP; Unit of measure: mmHg
Baseline, 24 hours and 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pisa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3399/11_C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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