Clinical trial NCT03087266: Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Diabetes
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2017-03-22
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
Intervention model description: single-centre randomized controlled clinical trial with a 3- month follow-up
Primary purpose: TREATMENT

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.


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.

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: Glycemia
timeFrame: Baseline, 24 hours and 3 months after treatment
measure: Glycated Haemoglobin
timeFrame: Baseline, 24 hours 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, MClinDent, PhD
role: PRINCIPAL_INVESTIGATOR
References: