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NCT Number: NCT03087266

Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients

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.

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Key information

Conditions

Periodontitis Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Pisa

Pisa, 56126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FM-SRP

Procedure

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

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.

Primary outcomes

  1. Levels C-Reactive Protein

    Time frame: Baseline, 24 hours and 3 months after treatment

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

Secondary outcomes

  1. Full Mouth Plaque Score (FMPS)

    Time frame: Baseline and 3 months after treatment

    Changes in FMPS. Unit of Measure: %

  2. Full Mouth Bleeding Score (FMBS)

    Time frame: Baseline and 3 months after treatment

    Changes in FMBS. Unit of Measure: %

  3. Pocket probing depth (PPD)

    Time frame: Baseline and 3 months after treatment

    Changes in PPD. Unit of measure: mm

  4. Clinical attachment level (CAL)

    Time frame: Baseline and 3 months after treatment

    Changes in CAL. Unit of measure: mm

  5. Recession of the gingival margin (REC)

    Time frame: Baseline and 3 months after treatment

    Changes in REC. Unit of measure: mm

  6. Triglycerides

    Time frame: Baseline, 24 hours and 3 months after treatment

    Changes in triglycerides. Unit of measure: mmol/L

  7. Low-density lipoprotein (LDL)

    Time frame: Baseline, 24 hours and 3 months after treatment

    Changes in LDL. Unit of measure: mmol/L

  8. High-density lipoprotein (HDL)

    Time frame: Baseline, 24 hours and 3 months after treatment

    Changes in HDL. Unit of measure: mmol/L

  9. Cholesterol

    Time frame: Baseline, 24 hours and 3 months after treatment

    Changes in total cholesterol, Unit of measure: mmol/L

  10. Glycemia

    Time frame: Baseline, 24 hours and 3 months after treatment

    Changes in blood glucose level. Unit of measure: mg/dl

  11. Glycated Haemoglobin

    Time frame: Baseline, 24 hours and 3 months after treatment

    Changes in Glycated haemoglobin. Unit of measure: mmol/mol

  12. Insulin

    Time frame: Baseline, 24 hours and 3 months after treatment

    Changes in Insulin level

  13. Systolic Blood Pressure (SBP)

    Time frame: Baseline, 24 hours and 3 months after treatment

    Changes in SBP Unit of measure: mmHg

  14. Diastolic Blood Pressure (DBP)

    Time frame: Baseline, 24 hours and 3 months after treatment

    Changes in DBP. Unit of measure: mmHg

  15. Endothelial Function

    Time frame: Baseline, 24 hours and 3 months after treatment

    Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: %

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Acronym: PERIO-DIA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2017
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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