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Completed

NCT Number: NCT03122977

Acute-phase Response & Periodontal Treatment in Obese Patients

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.

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Key information

Conditions

Periodontal Diseases Body Weight Mouth Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Pisa

Pisa, 56121, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FM-SRP

Procedure

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

Other names: 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.

Other names: Quadrant scaling and root planing

Primary outcomes

  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 outcomes

  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: %

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

Acute-phase Response Following Full-mouth Versus Quadrant Non-surgical Periodontal Treatment in Obese Subjects: A Randomized Clinical Trial

Acronym: PERIO-OBESE

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Apr 21, 2017
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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