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Acute-phase Response & Periodontal Treatment in Obese Patients

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狀態
贊助商
University of Pisa

關鍵詞

抽象

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.

描述

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.

日期

最後驗證: 04/30/2018
首次提交: 03/07/2017
提交的預估入學人數: 04/17/2017
首次發布: 04/20/2017
上次提交的更新: 04/30/2018
最近更新發布: 05/01/2018
實際學習開始日期: 05/31/2016
預計主要完成日期: 05/31/2019
預計完成日期: 12/31/2019

狀況或疾病

Periodontal Diseases
Obesity

干預/治療

Procedure: Full mouth scaling and root planing

Procedure: Quadrant scaling and root planing

-

手臂組

干預/治療
Experimental: Full mouth scaling and root planing
FM-SRP Non surgical periodontal treatment will be performed in all dentition within 24 hours
Procedure: Full mouth scaling and root planing
Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.
Active Comparator: Quadrant scaling and root planing
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: Quadrant scaling and root planing
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.

資格標準

有資格學習的年齡 18 Years 至 18 Years
有資格學習的性別All
接受健康志願者
標準

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

結果

主要結果指標

1. Levels C-Reactive Protein [Baseline, 24 hours and 3 months after treatment]

Changes in C reactive protein (CRP). Unit of measure: mg/L

次要成果指標

1. Full Mouth Plaque Score (FMPS) [Baseline and 3 months after treatment]

Changes in FMPS. Unit of Measure: %

2. Full Mouth Bleeding Score (FMBS) [Baseline and 3 months after treatment]

Changes in FMBS. Unit of Measure: %

3. Pocket probing depth (PPD) [Baseline and 3 months after treatment]

Changes in PPD. Unit of Measure: mm

4. Clinical attachment level (CAL) [Baseline and 3 months after treatment]

Changes in CAL. Unit of Measure: mm

5. Recession of the gingival margin (REC) [Baseline and 3 months after treatment]

Changes in REC. Unit of Measure: mm

6. Triglycerides [Baseline, 24 hours and 3 months after treatment]

Changes in triglycerides. Unit of measure: mmol/L

7. Low-density lipoprotein (LDL) [Baseline, 24 hours and 3 months after treatment]

Changes in LDL. Unit of measure: mmol/L

8. High-density lipoprotein (HDL) [Baseline, 24 hours and 3 months after treatment]

Changes in HDL. Unit of measure: mmol/L

9. Cholesterol [Baseline, 24 hours and 3 months after treatment]

Changes in total cholesterol. Unit of measure: mmol/L

10. Glycaemia [Baseline, 24 hours and 3 months after treatment]

Changes in blood glucose level; Unit of measure: mg/dL

11. Glycated Hemoglobin [Baseline and 3 months after treatment]

Changes in Glycated Hemoglobin level; Unit of measure: mmol/mol

12. Insulin [Baseline, 24 hours and 3 months after treatment]

Changes in Insulin level; Unit of measure: μU/mL

13. Systolic Blood Pressure (SBP) [Baseline, 24 hours and 3 months after treatment]

Changes in SBP; Unit of measure: mmHg

14. Diastolic Blood Pressure (DBP) [Baseline, 24 hours and 3 months after treatment]

Changes in DBP; Unit of measure: mmHg

15. Endothelial Function [Baseline, 24 hours and 3 months after treatment]

Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: %

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