Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients

Diabetes Clinical Trial

— PERIO-DIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087266
• Other study ID #: 3399/11_A
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: November 2020

Study information

• Verified date: November 2020
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute-Phase Reaction
• Diabetes
• Diabetes Mellitus
• Periodontitis

Intervention

Procedure:
• FM-SRP
Non surgical periodontal treatment performed in all dentition within 1-2 appointments in a 24 hour time frame.
• 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.

Locations

Country	Name	City	State
Italy	University Hospital of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

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