Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients

Not Applicable

Completed

• Conditions: Diabetes; Periodontitis
• Interventions: Procedure: FM-SRP; Procedure: Q-SRP

• Registration Number: NCT03087266
• Lead Sponsor: University of Pisa

Brief Summary

Thirty-eight periodontitis- and diabetes-affected subjects will be randomly allocated to non surgical periodontal treatment with either Full-Mouth Approach (FM-SRP) or Quadrant approach (Q-SRP).

Patients will be seen one day and three months (study completion) after treatment. The 24 hours appointment will be occurring after the entire completion of the FM-SRP or the first quadrant of the Q-SRP. In the latter group other sessions of treatment will be performed within the following 3 weeks.

At baseline, 24 hours and three months, anthropometric, inflammatory and endothelial parameters will be collected. Periodontal parameters will be checked at baseline and at three months.

Main outcome of the study is the level of C-reactive protein 24 hours after treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-22
• Status Verified: 2020-11
• Primary Completion: 2020-11
• Study Completion: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 Diabetes Type 2 as measured through international standards

Exclusion Criteria

• age younger than 18 years and older than 80 years
• pregnant or lactating females
• females using contraceptive methods
• need of antibiotic coverage for periodontal treatment
• previous periodontal treatment in the last 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full- Mouth Scaling and Root Planing	FM-SRP	FM-SRP Non-surgical periodontal treatment will be performed in all dentition within 24 hours.
Quadrant Scaling and Root Planing	Q-SRP	Q-SRP Non-surgical periodontal treatment will be performed in all dentition subdivided in four appointments. Each appointment will be performed with one week interval. In each appointment only a "quadrant" of the dentition will be instrumented.

Primary Outcome Measures

Name	Time	Method
Levels C-Reactive Protein	Baseline, 24 hours and 3 months after treatment	Changes in C reactive protein (CRP). Unit of measure: mg/L

Secondary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure (DBP)	Baseline, 24 hours and 3 months after treatment	Changes in DBP. Unit of measure: mmHg
Clinical attachment level (CAL)	Baseline and 3 months after treatment	Changes in CAL. Unit of measure: mm
Low-density lipoprotein (LDL)	Baseline, 24 hours and 3 months after treatment	Changes in LDL. Unit of measure: mmol/L
Full Mouth Bleeding Score (FMBS)	Baseline and 3 months after treatment	Changes in FMBS. Unit of Measure: %
Recession of the gingival margin (REC)	Baseline and 3 months after treatment	Changes in REC. Unit of measure: mm
Full Mouth Plaque Score (FMPS)	Baseline and 3 months after treatment	Changes in FMPS. Unit of Measure: %
Pocket probing depth (PPD)	Baseline and 3 months after treatment	Changes in PPD. Unit of measure: mm
Triglycerides	Baseline, 24 hours and 3 months after treatment	Changes in triglycerides. Unit of measure: mmol/L
Cholesterol	Baseline, 24 hours and 3 months after treatment	Changes in total cholesterol, 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
Glycated Haemoglobin	Baseline, 24 hours and 3 months after treatment	Changes in Glycated haemoglobin. Unit of measure: mmol/mol
Systolic Blood Pressure (SBP)	Baseline, 24 hours and 3 months after treatment	Changes in SBP 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: %
Glycemia	Baseline, 24 hours and 3 months after treatment	Changes in blood glucose level. Unit of measure: mg/dl
Insulin	Baseline, 24 hours and 3 months after treatment	Changes in Insulin level

Trial Locations

Locations (1)

University Hospital of Pisa; 🇮🇹 Pisa, Italy