Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients

Study Overview
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Brief Summary
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Thirty-eight periodontitis- and diabetes-affected subjects will be randomly allocated to non surgical periodontal treatment with either Full-Mouth Approach (FM-SRP) or Quadrant approach (Q-SRP). Patients will be seen one day and three months (study completion) after treatment. The 24 hours appointment will be occurring after the entire completion of the FM-SRP or the first quadrant of the Q-SRP. In the latter group other sessions of treatment will be performed within the following 3 weeks. At baseline, 24 hours and three months, anthropometric, inflammatory and endothelial parameters will be collected. Periodontal parameters will be checked at baseline and at three months. Main outcome of the study is the level of C-reactive protein 24 hours after treatment.

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

Conditions
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Periodontitis, Diabetes

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 Diabetes Type 2 as measured through international standards Exclusion Criteria: age younger than 18 years and older than 80 years pregnant or lactating females females using contraceptive methods need of antibiotic coverage for periodontal treatment previous periodontal treatment in the last 6 months.

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
Interventional Model Description: single-centre randomized controlled clinical trial with a 3- month follow-up
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>* Non surgical periodontal treatment performed in all dentition within 1-2 appointments in a 24 hour time frame.<br>|
| 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 with one week interval. In each appointment only a quadrant of the dentition will be instrumented. | Procedure: Q-SRP<br>* Non surgical periodontal treatment performed in 4 sessions comprising of a quadrant (1/4) of the dentition each. Performed in 3 weeks time frame.<br>|

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 | 
| Glycemia | Changes in blood glucose level. Unit of measure: mg/dl | Baseline, 24 hours and 3 months after treatment | 
| Glycated Haemoglobin | Changes in Glycated haemoglobin. Unit of measure: mmol/mol | Baseline, 24 hours and 3 months after treatment | 
| Insulin | Changes in Insulin level | 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 |