Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients

NCT03087266 | Completed

• 1 other identifier: 3399/11_A
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Diabetes

Outcome Measures

Primary Outcomes (1)

• Levels C-Reactive Protein

  Changes in C reactive protein (CRP). Unit of measure: mg/L

  Baseline, 24 hours and 3 months after treatment

Secondary Outcomes (15)

• Full Mouth Plaque Score (FMPS)

  Baseline and 3 months after treatment

• Full Mouth Bleeding Score (FMBS)

  Baseline and 3 months after treatment

• Pocket probing depth (PPD)

  Baseline and 3 months after treatment

• Clinical attachment level (CAL)

  Baseline and 3 months after treatment

• Recession of the gingival margin (REC)

  Baseline and 3 months after treatment

Study Arms (2)

Full- Mouth Scaling and Root Planing

EXPERIMENTAL

FM-SRP Non-surgical periodontal treatment will be performed in all dentition within 24 hours.

Procedure: FM-SRP

Quadrant Scaling and Root Planing

ACTIVE COMPARATOR

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.

Procedure: Q-SRP

Interventions

FM-SRP PROCEDURE

Non surgical periodontal treatment performed in all dentition within 1-2 appointments in a 24 hour time frame.

Full- Mouth Scaling and Root Planing

Q-SRP PROCEDURE

Non surgical periodontal treatment performed in 4 sessions comprising of a quadrant (1/4) of the dentition each. Performed in 3 weeks time frame.

Quadrant Scaling and Root Planing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected by Periodontal disease
• % of periodontal pockets of the entire dentition
• % bleeding on probing of the entire dentition
• documented radiographic bone loss
• Diagnosis of Diabetes Type 2 as measured through international standards

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University Hospital of Pisa

Pisa, 56126, Italy

Location

Related Publications (1)

• 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.

  PMID: 36517997 DERIVED

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Filippo Graziani, DDS, MClinDent, PhD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Periodontology

Model Details: single-centre randomized controlled clinical trial with a 3- month follow-up

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 22, 2017
• Study Start: June 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

IT (1)