Clinical trial NCT03122977: Acute-phase Response & Periodontal Treatment in Obese Patients
Official title: Acute-phase Response Following Full-mouth Versus Quadrant Non-surgical Periodontal Treatment in Obese Subjects: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Obesity
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Levels C-Reactive Protein
timeFrame: Baseline, 24 hours and 3 months after treatment
Secondary outcomes:
measure: Full Mouth Plaque Score (FMPS)
timeFrame: Baseline and 3 months after treatment
measure: Full Mouth Bleeding Score (FMBS)
timeFrame: Baseline and 3 months after treatment
measure: Pocket probing depth (PPD)
timeFrame: Baseline and 3 months after treatment
measure: Clinical attachment level (CAL)
timeFrame: Baseline and 3 months after treatment
measure: Recession of the gingival margin (REC)
timeFrame: Baseline and 3 months after treatment
measure: Triglycerides
timeFrame: Baseline, 24 hours and 3 months after treatment
measure: Low-density lipoprotein (LDL)
timeFrame: Baseline, 24 hours and 3 months after treatment
measure: High-density lipoprotein (HDL)
timeFrame: Baseline, 24 hours and 3 months after treatment
measure: Cholesterol
timeFrame: Baseline, 24 hours and 3 months after treatment
measure: Glycaemia
timeFrame: Baseline, 24 hours and 3 months after treatment
measure: Glycated Hemoglobin
timeFrame: Baseline and 3 months after treatment
measure: Insulin
timeFrame: Baseline, 24 hours and 3 months after treatment
measure: Systolic Blood Pressure (SBP)
timeFrame: Baseline, 24 hours and 3 months after treatment
measure: Diastolic Blood Pressure (DBP)
timeFrame: Baseline, 24 hours and 3 months after treatment
measure: Endothelial Function
timeFrame: Baseline, 24 hours and 3 months after treatment
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University Hospital of Pisa
Study officials:
affiliation: University of Pisa
name: Filippo Graziani, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: