Periodontal Diseases, Obesity
Conditions
Brief summary
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
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.
Interventions
PROCEDUREFM-SRP
Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.
PROCEDUREQ-SRP
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.
Sponsors
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
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 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
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 |
|---|---|---|
| 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 |
| Low-density lipoprotein (LDL) | Baseline, 24 hours and 3 months after treatment | Changes in LDL. Unit of measure: mmol/L |
| High-density lipoprotein (HDL) | Baseline, 24 hours and 3 months after treatment | Changes in HDL. Unit of measure: mmol/L |
| Full Mouth Plaque Score (FMPS) | Baseline and 3 months after treatment | Changes in FMPS. Unit of Measure: % |
| Glycaemia | Baseline, 24 hours and 3 months after treatment | Changes in blood glucose level; Unit of measure: mg/dL |
| Glycated Hemoglobin | Baseline and 3 months after treatment | Changes in Glycated Hemoglobin level; Unit of measure: mmol/mol |
| Insulin | Baseline, 24 hours and 3 months after treatment | Changes in Insulin level; Unit of measure: μU/mL |
| Systolic Blood Pressure (SBP) | Baseline, 24 hours and 3 months after treatment | Changes in SBP; Unit of measure: mmHg |
| 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: % |
| Cholesterol | Baseline, 24 hours and 3 months after treatment | Changes in total cholesterol. Unit of measure: mmol/L |
Countries
Italy
Outcome results
None listed