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Acute-phase Response & Periodontal Treatment in Obese Patients (PERIO-OBESE)

Primary Purpose

Periodontal Diseases, Obesity

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
FM-SRP
Q-SRP
Sponsored by
University of Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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 Obesity as measured through Body Mass Index (BMI) superior than 30

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 statin and/or acetylsalicylic acid
  • BMI > 35

Sites / Locations

  • University Hospital of Pisa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full mouth scaling and root planing

Quadrant scaling and root planing

Arm Description

FM-SRP Non surgical periodontal treatment will be performed in all dentition within 24 hours

Q-SRP Non 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2017
Last Updated
November 2, 2022
Sponsor
University of Pisa
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1. Study Identification

Unique Protocol Identification Number
NCT03122977
Brief Title
Acute-phase Response & Periodontal Treatment in Obese Patients
Acronym
PERIO-OBESE
Official Title
Acute-phase Response Following Full-mouth Versus Quadrant Non-surgical Periodontal Treatment in Obese Subjects: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 no surgical periodontal treatment in obese patients affected by periodontitis.
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 obese patients with periodontitis. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full mouth scaling and root planing
Arm Type
Experimental
Arm Description
FM-SRP Non surgical periodontal treatment will be performed in all dentition within 24 hours
Arm Title
Quadrant scaling and root planing
Arm Type
Active Comparator
Arm Description
Q-SRP Non 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.
Intervention Type
Procedure
Intervention Name(s)
FM-SRP
Other Intervention Name(s)
Full mouth scaling and root planing
Intervention Description
Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.
Intervention Type
Procedure
Intervention Name(s)
Q-SRP
Other Intervention Name(s)
Quadrant scaling and root planing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Levels C-Reactive Protein
Description
Changes in C reactive protein (CRP). Unit of measure: mg/L
Time Frame
Baseline, 24 hours and 3 months after treatment
Secondary Outcome Measure Information:
Title
Full Mouth Plaque Score (FMPS)
Description
Changes in FMPS. Unit of Measure: %
Time Frame
Baseline and 3 months after treatment
Title
Full Mouth Bleeding Score (FMBS)
Description
Changes in FMBS. Unit of Measure: %
Time Frame
Baseline and 3 months after treatment
Title
Pocket probing depth (PPD)
Description
Changes in PPD. Unit of Measure: mm
Time Frame
Baseline and 3 months after treatment
Title
Clinical attachment level (CAL)
Description
Changes in CAL. Unit of Measure: mm
Time Frame
Baseline and 3 months after treatment
Title
Recession of the gingival margin (REC)
Description
Changes in REC. Unit of Measure: mm
Time Frame
Baseline and 3 months after treatment
Title
Triglycerides
Description
Changes in triglycerides. Unit of measure: mmol/L
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Low-density lipoprotein (LDL)
Description
Changes in LDL. Unit of measure: mmol/L
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
High-density lipoprotein (HDL)
Description
Changes in HDL. Unit of measure: mmol/L
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Cholesterol
Description
Changes in total cholesterol. Unit of measure: mmol/L
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Glycaemia
Description
Changes in blood glucose level; Unit of measure: mg/dL
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Glycated Hemoglobin
Description
Changes in Glycated Hemoglobin level; Unit of measure: mmol/mol
Time Frame
Baseline and 3 months after treatment
Title
Insulin
Description
Changes in Insulin level; Unit of measure: μU/mL
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Systolic Blood Pressure (SBP)
Description
Changes in SBP; Unit of measure: mmHg
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Diastolic Blood Pressure (DBP)
Description
Changes in DBP; Unit of measure: mmHg
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Endothelial Function
Description
Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: %
Time Frame
Baseline, 24 hours and 3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Obesity as measured through Body Mass Index (BMI) superior than 30 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 statin and/or acetylsalicylic acid BMI > 35
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filippo Graziani, DDS, PhD
Organizational Affiliation
University of Pisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Pisa
City
Pisa
ZIP/Postal Code
56121
Country
Italy

12. IPD Sharing Statement

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Acute-phase Response & Periodontal Treatment in Obese Patients

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