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

U

University of Pisa

Status

Completed

Conditions

Periodontitis
Diabetes

Treatments

Procedure: FM-SRP
Procedure: Q-SRP

Study type

Interventional

Funder types

Other

Identifiers

NCT03087266
3399/11_A

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

38 participants in 2 patient groups

Full- Mouth Scaling and Root Planing
Experimental group
Description:
FM-SRP Non-surgical periodontal treatment will be performed in all dentition within 24 hours.
Treatment:
Procedure: FM-SRP
Quadrant Scaling and Root Planing
Active Comparator group
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.
Treatment:
Procedure: Q-SRP

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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