Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients (PERIO-DIA)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Periodontitis
• Intervention / Treatment: Procedure: FM-SRP; Procedure: Q-SRP

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56126
    • University Hospital of Pisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full- Mouth Scaling and Root Planing; FM-SRP Non-surgical periodontal treatment will be performed in all dentition within 24 hours.	Procedure: FM-SRP; Non surgical periodontal treatment performed in all dentition within 1-2 appointments in a 24 hour time frame.
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 with one week interval. In each appointment only a "quadrant" of the dentition will be instrumented.	Procedure: Q-SRP; Non surgical periodontal treatment performed in 4 sessions comprising of a quadrant (1/4) of the dentition each. Performed in 3 weeks time frame.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pisa
• Investigators: Principal Investigator: Filippo Graziani, DDS, MClinDent, PhD, University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Inflammation; Endocrine System Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Diabetes Mellitus; Periodontitis; Acute-Phase Reaction
• Other Study ID Numbers: 3399/11_A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No