Acute-phase Response & Periodontal Treatment in Obese Patients

Obesity Clinical Trial

— PERIO-OBESE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122977
• Other study ID #: 3399/11_B
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2022
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-Phase Reaction
• Obesity
• Periodontal Diseases

Intervention

Procedure:
• FM-SRP
Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.
• Q-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.

Locations

Country	Name	City	State
Italy	University Hospital of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels C-Reactive Protein	Changes in C reactive protein (CRP). Unit of measure: mg/L	Baseline, 24 hours and 3 months after treatment
Secondary	Full Mouth Plaque Score (FMPS)	Changes in FMPS. Unit of Measure: %	Baseline and 3 months after treatment
Secondary	Full Mouth Bleeding Score (FMBS)	Changes in FMBS. Unit of Measure: %	Baseline and 3 months after treatment
Secondary	Pocket probing depth (PPD)	Changes in PPD. Unit of Measure: mm	Baseline and 3 months after treatment
Secondary	Clinical attachment level (CAL)	Changes in CAL. Unit of Measure: mm	Baseline and 3 months after treatment
Secondary	Recession of the gingival margin (REC)	Changes in REC. Unit of Measure: mm	Baseline and 3 months after treatment
Secondary	Triglycerides	Changes in triglycerides. Unit of measure: mmol/L	Baseline, 24 hours and 3 months after treatment
Secondary	Low-density lipoprotein (LDL)	Changes in LDL. Unit of measure: mmol/L	Baseline, 24 hours and 3 months after treatment
Secondary	High-density lipoprotein (HDL)	Changes in HDL. Unit of measure: mmol/L	Baseline, 24 hours and 3 months after treatment
Secondary	Cholesterol	Changes in total cholesterol. Unit of measure: mmol/L	Baseline, 24 hours and 3 months after treatment
Secondary	Glycaemia	Changes in blood glucose level; Unit of measure: mg/dL	Baseline, 24 hours and 3 months after treatment
Secondary	Glycated Hemoglobin	Changes in Glycated Hemoglobin level; Unit of measure: mmol/mol	Baseline and 3 months after treatment
Secondary	Insulin	Changes in Insulin level; Unit of measure: µU/mL	Baseline, 24 hours and 3 months after treatment
Secondary	Systolic Blood Pressure (SBP)	Changes in SBP; Unit of measure: mmHg	Baseline, 24 hours and 3 months after treatment
Secondary	Diastolic Blood Pressure (DBP)	Changes in DBP; Unit of measure: mmHg	Baseline, 24 hours and 3 months after treatment
Secondary	Endothelial Function	Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: %	Baseline, 24 hours and 3 months after treatment