Periodontitis, Diabetes
Conditions
Brief summary
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.
Interventions
Sponsors
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
single-centre randomized controlled clinical trial with a 3- month follow-up
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels C-Reactive Protein | Baseline, 24 hours and 3 months after treatment | Changes in C reactive protein (CRP). Unit of measure: mg/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) | Baseline, 24 hours and 3 months after treatment | Changes in SBP Unit of measure: mmHg |
| Full Mouth Plaque Score (FMPS) | Baseline and 3 months after treatment | Changes in FMPS. Unit of Measure: % |
| Full Mouth Bleeding Score (FMBS) | Baseline and 3 months after treatment | Changes in FMBS. Unit of Measure: % |
| Pocket probing depth (PPD) | Baseline and 3 months after treatment | Changes in PPD. Unit of measure: mm |
| Clinical attachment level (CAL) | Baseline and 3 months after treatment | Changes in CAL. Unit of measure: mm |
| Recession of the gingival margin (REC) | Baseline and 3 months after treatment | Changes in REC. Unit of measure: mm |
| Triglycerides | Baseline, 24 hours and 3 months after treatment | Changes in triglycerides. Unit of measure: mmol/L |
| Insulin | Baseline, 24 hours and 3 months after treatment | Changes in Insulin level |
| High-density lipoprotein (HDL) | Baseline, 24 hours and 3 months after treatment | Changes in HDL. Unit of measure: mmol/L |
| Cholesterol | Baseline, 24 hours and 3 months after treatment | Changes in total cholesterol, Unit of measure: mmol/L |
| Glycemia | Baseline, 24 hours and 3 months after treatment | Changes in blood glucose level. Unit of measure: mg/dl |
| Glycated Haemoglobin | Baseline, 24 hours and 3 months after treatment | Changes in Glycated haemoglobin. Unit of measure: mmol/mol |
| Diastolic Blood Pressure (DBP) | Baseline, 24 hours and 3 months after treatment | Changes in DBP. Unit of measure: mmHg |
| Endothelial Function | Baseline, 24 hours and 3 months after treatment | Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: % |
| Low-density lipoprotein (LDL) | Baseline, 24 hours and 3 months after treatment | Changes in LDL. Unit of measure: mmol/L |
Countries
Italy
Outcome results
None listed