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

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ClinicalTrials.gov Identifier: NCT03122977
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Filippo Graziani, DDS MClinDent PhD, 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 no surgical periodontal treatment in obese patients affected by periodontitis.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Obesity Procedure: FM-SRP Procedure: Q-SRP Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute-phase Response Following Full-mouth Versus Quadrant Non-surgical Periodontal Treatment in Obese Subjects: A Randomized Clinical Trial
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : January 1, 2020

Arm Intervention/treatment
Experimental: Full mouth scaling and root planing
FM-SRP Non surgical periodontal treatment will be performed in all dentition within 24 hours
Procedure: FM-SRP
Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.
Other Name: Full mouth scaling and root planing

Active Comparator: Quadrant scaling and root planing
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.
Procedure: 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.
Other Name: Quadrant scaling and root planing




Primary Outcome Measures :
  1. Levels C-Reactive Protein [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in C reactive protein (CRP). Unit of measure: mg/L


Secondary Outcome Measures :
  1. Full Mouth Plaque Score (FMPS) [ Time Frame: Baseline and 3 months after treatment ]
    Changes in FMPS. Unit of Measure: %

  2. Full Mouth Bleeding Score (FMBS) [ Time Frame: Baseline and 3 months after treatment ]
    Changes in FMBS. Unit of Measure: %

  3. Pocket probing depth (PPD) [ Time Frame: Baseline and 3 months after treatment ]
    Changes in PPD. Unit of Measure: mm

  4. Clinical attachment level (CAL) [ Time Frame: Baseline and 3 months after treatment ]
    Changes in CAL. Unit of Measure: mm

  5. Recession of the gingival margin (REC) [ Time Frame: Baseline and 3 months after treatment ]
    Changes in REC. Unit of Measure: mm

  6. Triglycerides [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in triglycerides. Unit of measure: mmol/L

  7. Low-density lipoprotein (LDL) [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in LDL. Unit of measure: mmol/L

  8. High-density lipoprotein (HDL) [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in HDL. Unit of measure: mmol/L

  9. Cholesterol [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in total cholesterol. Unit of measure: mmol/L

  10. Glycaemia [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in blood glucose level; Unit of measure: mg/dL

  11. Glycated Hemoglobin [ Time Frame: Baseline and 3 months after treatment ]
    Changes in Glycated Hemoglobin level; Unit of measure: mmol/mol

  12. Insulin [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in Insulin level; Unit of measure: μU/mL

  13. Systolic Blood Pressure (SBP) [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in SBP; Unit of measure: mmHg

  14. Diastolic Blood Pressure (DBP) [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in DBP; Unit of measure: mmHg

  15. Endothelial Function [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: %



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122977


Contacts
Contact: Morena Petrini, DDS, PhD +3905093073

Locations
Italy
University Hospital of Pisa Recruiting
Pisa, Italy, 56121
Contact: Filippo Graziani, DDS, PhD    0039050992939    filippo.graziani@med.unipi.it   
Sponsors and Collaborators
University of Pisa
Investigators
Principal Investigator: Filippo Graziani, DDS, PhD University of Pisa

Responsible Party: Filippo Graziani, DDS MClinDent PhD, Professor of Periodontology, University of Pisa
ClinicalTrials.gov Identifier: NCT03122977     History of Changes
Other Study ID Numbers: 3399/11_B
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

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

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Acute-Phase Reaction
Mouth Diseases
Stomatognathic Diseases
Inflammation
Pathologic Processes