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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full- Mouth Scaling and Root Planing | Experimental | FM-SRP Non-surgical periodontal treatment will be performed in all dentition within 24 hours. |
|
| Quadrant Scaling and Root Planing | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FM-SRP | Procedure | Non surgical periodontal treatment performed in all dentition within 1-2 appointments in a 24 hour time frame. |
|
| 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 |
| 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: % |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Filippo Graziani, DDS, MClinDent, PhD | University of Pisa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Pisa | Pisa | 56126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36517997 | Derived | Graziani F, Gennai S, Marruganti C, Peric M, Ghiadoni L, Marhl U, Petrini M. Acute-phase response following one-stage full-mouth versus quadrant non-surgical periodontal treatment in subjects with comorbid type 2 diabetes: A randomized clinical trial. J Clin Periodontol. 2023 Apr;50(4):487-499. doi: 10.1111/jcpe.13760. Epub 2023 Jan 22. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D044882 | Glucose Metabolism Disorders |
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single-centre randomized controlled clinical trial with a 3- month follow-up
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| Q-SRP | Procedure | Non surgical periodontal treatment performed in 4 sessions comprising of a quadrant (1/4) of the dentition each. Performed in 3 weeks time frame. |
|
| 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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |