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

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: Completed
• Conditions: Hypertension; Periodontitis
• Intervention / Treatment: Procedure: FM-SRP; Procedure: Q-SRP

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: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Levels C-Reactive Protein	Changes in C reactive protein (CRP). Unit of measure: mg/L	Baseline, 24 hours and 3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full Mouth Plaque Score (FMPS)	Changes in FMPS. Unit of Measure: %	Baseline and 3 months after treatment
Full Mouth Bleeding Score (FMBS)	Changes in FMBS. Unit of Measure: %	Baseline and 3 months after treatment
Triglycerides	Changes in triglycerides. Unit of measure: mmol/L	Baseline, 24 hours and 3 months after treatment
Low-density lipoprotein (LDL)	Changes in LDL. Unit of measure: mmol/L	Baseline, 24 hours and 3 months after treatment
High-density lipoprotein (HDL)	Changes in HDL. Unit of measure: mmol/L	Baseline, 24 hours and 3 months after treatment
Endothelial Function	Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: %	Baseline, 24 hours and 3 months after treatment
Pocket probing depth (PPD)	Changes in PPD. Unit of Measure: mm	Baseline and 3 months after treatment
Clinical attachment level (CAL)	Changes in CAL. Unit of Measure: mm	Baseline and 3 months after treatment
Recession of the gingival margin (REC)	Changes in REC. Unit of Measure: mm	Baseline and 3 months after treatment
Cholesterol	Changes in total cholesterol. Unit of measure: mmol/L	Baseline, 24 hours and 3 months after treatment
Glycaemia	Changes in blood glucose level; Unit of measure: mg/dL	Baseline, 24 hours and 3 months after treatment
Glycated Hemoglobin	Changes in Glycated Hemoglobin level; Unit of measure: mmol/mol	Baseline and 3 months after treatment
Insulin	Changes in Insulin level; Unit of measure: μU/mL	Baseline, 24 hours and 3 months after treatment
Systolic Blood Pressure (SBP)	Changes in SBP; Unit of measure: mmHg	Baseline, 24 hours and 3 months after treatment
Diastolic Blood Pressure (DBP)	Changes in DBP; Unit of measure: mmHg	Baseline, 24 hours and 3 months after treatment

Collaborators and Investigators

• Sponsor: University of Pisa

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (ACTUAL): April 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Inflammation; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Hypertension; Periodontitis; Acute-Phase Reaction
• Other Study ID 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