Acute-phase Response & Periodontal Treatment in Patients With Hypertension

Not Applicable

Completed

• Conditions: Periodontitis; Hypertension
• Interventions: Procedure: FM-SRP; Procedure: Q-SRP

• Registration Number: NCT03122990
• Lead Sponsor: University of Pisa

Brief Summary

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.

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 Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-21
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full mouth scaling and root planing	FM-SRP	FM-SRP No surgical periodontal treatment will be performed in all dentition within 24 hours
Quadrant Scaling and Root Planing	Q-SRP	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Pisa; 🇮🇹 Pisa, Italy