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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03122990
Other study ID # 3399/11_C
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2016
Est. completion date June 30, 2019

Study information

Verified date November 2020
Source University of Pisa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 30, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy University Hospital of Pisa Pisa

Sponsors (1)

Lead Sponsor Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

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