Acute-phase Response & Periodontal Treatment in Obese Patients (PERIO-OBESE)

University of Pisa

Status: Completed

Conditions: Periodontal Diseases; Obesity

Treatments: Procedure: FM-SRP; Procedure: Q-SRP

Study type: Interventional

Funder types: Other

Identifiers

NCT03122977

3399/11_B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Full mouth scaling and root planing

Experimental group

Description:

FM-SRP Non surgical periodontal treatment will be performed in all dentition within 24 hours

Treatment:

Procedure: FM-SRP

Quadrant scaling and root planing

Active Comparator group

Description:

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.

Treatment:

Procedure: Q-SRP