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

U

University of Pisa

Status

Completed

Conditions

Hypertension
Periodontitis

Treatments

Procedure: Q-SRP
Procedure: FM-SRP

Study type

Interventional

Funder types

Other

Identifiers

NCT03122990
3399/11_C

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Full mouth scaling and root planing
Experimental group
Description:
FM-SRP No surgical periodontal treatment will be performed in all dentition within 24 hours
Treatment:
Procedure: FM-SRP
Quadrant Scaling and Root Planing
Active Comparator group
Description:
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.
Treatment:
Procedure: Q-SRP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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