Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients (PERIO-DIA)
Primary Purpose
Periodontitis, Diabetes
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
FM-SRP
Q-SRP
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
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 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.
Sites / Locations
- University Hospital of Pisa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Full- Mouth Scaling and Root Planing
Quadrant Scaling and Root Planing
Arm Description
FM-SRP Non-surgical periodontal treatment will be performed in all dentition within 24 hours.
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.
Outcomes
Primary Outcome Measures
Levels C-Reactive Protein
Changes in C reactive protein (CRP). Unit of measure: mg/L
Secondary Outcome Measures
Full Mouth Plaque Score (FMPS)
Changes in FMPS. Unit of Measure: %
Full Mouth Bleeding Score (FMBS)
Changes in FMBS. Unit of Measure: %
Pocket probing depth (PPD)
Changes in PPD. Unit of measure: mm
Clinical attachment level (CAL)
Changes in CAL. Unit of measure: mm
Recession of the gingival margin (REC)
Changes in REC. Unit of measure: mm
Triglycerides
Changes in triglycerides. Unit of measure: mmol/L
Low-density lipoprotein (LDL)
Changes in LDL. Unit of measure: mmol/L
High-density lipoprotein (HDL)
Changes in HDL. Unit of measure: mmol/L
Cholesterol
Changes in total cholesterol, Unit of measure: mmol/L
Glycemia
Changes in blood glucose level. Unit of measure: mg/dl
Glycated Haemoglobin
Changes in Glycated haemoglobin. Unit of measure: mmol/mol
Insulin
Changes in Insulin level
Systolic Blood Pressure (SBP)
Changes in SBP Unit of measure: mmHg
Diastolic Blood Pressure (DBP)
Changes in DBP. Unit of measure: mmHg
Endothelial Function
Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: %
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03087266
Brief Title
Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients
Acronym
PERIO-DIA
Official Title
Acute-phase Response Following Full-mouth Versus Quadrant Non-surgical Periodontal Treatment in Diabetes-affected Subjects: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
November 2020 (Actual)
Study Completion Date
November 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-centre randomized controlled clinical trial with a 3- month follow-up
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full- Mouth Scaling and Root Planing
Arm Type
Experimental
Arm Description
FM-SRP Non-surgical periodontal treatment will be performed in all dentition within 24 hours.
Arm Title
Quadrant Scaling and Root Planing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
FM-SRP
Intervention Description
Non surgical periodontal treatment performed in all dentition within 1-2 appointments in a 24 hour time frame.
Intervention Type
Procedure
Intervention Name(s)
Q-SRP
Intervention Description
Non surgical periodontal treatment performed in 4 sessions comprising of a quadrant (1/4) of the dentition each. Performed in 3 weeks time frame.
Primary Outcome Measure Information:
Title
Levels C-Reactive Protein
Description
Changes in C reactive protein (CRP). Unit of measure: mg/L
Time Frame
Baseline, 24 hours and 3 months after treatment
Secondary Outcome Measure Information:
Title
Full Mouth Plaque Score (FMPS)
Description
Changes in FMPS. Unit of Measure: %
Time Frame
Baseline and 3 months after treatment
Title
Full Mouth Bleeding Score (FMBS)
Description
Changes in FMBS. Unit of Measure: %
Time Frame
Baseline and 3 months after treatment
Title
Pocket probing depth (PPD)
Description
Changes in PPD. Unit of measure: mm
Time Frame
Baseline and 3 months after treatment
Title
Clinical attachment level (CAL)
Description
Changes in CAL. Unit of measure: mm
Time Frame
Baseline and 3 months after treatment
Title
Recession of the gingival margin (REC)
Description
Changes in REC. Unit of measure: mm
Time Frame
Baseline and 3 months after treatment
Title
Triglycerides
Description
Changes in triglycerides. Unit of measure: mmol/L
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Low-density lipoprotein (LDL)
Description
Changes in LDL. Unit of measure: mmol/L
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
High-density lipoprotein (HDL)
Description
Changes in HDL. Unit of measure: mmol/L
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Cholesterol
Description
Changes in total cholesterol, Unit of measure: mmol/L
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Glycemia
Description
Changes in blood glucose level. Unit of measure: mg/dl
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Glycated Haemoglobin
Description
Changes in Glycated haemoglobin. Unit of measure: mmol/mol
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Insulin
Description
Changes in Insulin level
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Systolic Blood Pressure (SBP)
Description
Changes in SBP Unit of measure: mmHg
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Diastolic Blood Pressure (DBP)
Description
Changes in DBP. Unit of measure: mmHg
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Endothelial Function
Description
Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: %
Time Frame
Baseline, 24 hours and 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filippo Graziani, DDS, MClinDent, PhD
Organizational Affiliation
University of Pisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Pisa
City
Pisa
ZIP/Postal Code
56126
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients
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