Acute-phase Response & Periodontal Treatment in Obese Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periodontal Diseases, Obesity

Intervention / Treatment
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* Procedure: FM-SRP
* Procedure: Q-SRP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full mouth scaling and root planing<br>FM-SRP Non surgical periodontal treatment will be performed in all dentition within 24 hours | Procedure: FM-SRP<br>* Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.<br>* Other names: Full mouth scaling and root planing;|
| Active Comparator: Quadrant scaling and root planing<br>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<br>* 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.<br>* Other names: Quadrant scaling and root planing;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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