Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients
NCT ID: NCT03087266
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2016-06-01
2020-11-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Full- Mouth Scaling and Root Planing
FM-SRP Non-surgical periodontal treatment will be performed in all dentition within 24 hours.
FM-SRP
Non surgical periodontal treatment performed in all dentition within 1-2 appointments in a 24 hour time frame.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* pregnant or lactating females
* females using contraceptive methods
* need of antibiotic coverage for periodontal treatment
* previous periodontal treatment in the last 6 months.
18 Years
80 Years
ALL
No
Sponsors
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University of Pisa
OTHER
Responsible Party
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Filippo Graziani, DDS MClinDent PhD
Professor of Periodontology
Principal Investigators
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Filippo Graziani, DDS, MClinDent, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pisa
Locations
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University Hospital of Pisa
Pisa, , Italy
Countries
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References
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Graziani F, Gennai S, Marruganti C, Peric M, Ghiadoni L, Marhl U, Petrini M. Acute-phase response following one-stage full-mouth versus quadrant non-surgical periodontal treatment in subjects with comorbid type 2 diabetes: A randomized clinical trial. J Clin Periodontol. 2023 Apr;50(4):487-499. doi: 10.1111/jcpe.13760. Epub 2023 Jan 22.
Other Identifiers
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3399/11_A
Identifier Type: -
Identifier Source: org_study_id