Acute-phase Response & Periodontal Treatment in Patients With Hypertension

NCT03122990 | Completed

• 1 other identifier: 3399/11_C
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Hypertension

Outcome Measures

Primary Outcomes (1)

• Levels C-Reactive Protein

  Changes in C reactive protein (CRP). Unit of measure: mg/L

  Baseline, 24 hours and 3 months after treatment

Secondary Outcomes (15)

• Full Mouth Plaque Score (FMPS)

  Baseline and 3 months after treatment

• Full Mouth Bleeding Score (FMBS)

  Baseline and 3 months after treatment

• Pocket probing depth (PPD)

  Baseline and 3 months after treatment

• Clinical attachment level (CAL)

  Baseline and 3 months after treatment

• Recession of the gingival margin (REC)

  Baseline and 3 months after treatment

Study Arms (2)

Full mouth scaling and root planing

EXPERIMENTAL

FM-SRP No surgical periodontal treatment will be performed in all dentition within 24 hours

Procedure: FM-SRP

Quadrant Scaling and Root Planing

ACTIVE COMPARATOR

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

Interventions

FM-SRP PROCEDURE

Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.

Also known as: Full mouth scaling and root planing

Full mouth scaling and root planing

Q-SRP PROCEDURE

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.

Also known as: Quadrant scaling and root planing

Quadrant Scaling and Root Planing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University Hospital of Pisa

Pisa, 56121, Italy

Location

MeSH Terms

Conditions

Periodontitis; Hypertension

Interventions

Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Filippo Graziani, DDS, PhD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Periodontology

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: April 21, 2017
• Study Start: June 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

IT (1)