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Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients

Primary Purpose

Chronic Periodontitis, Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nonsurgical periodontal treatment
Dental Prophylaxis
Sponsored by
University of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring dental root planing and scaling, periodontal disease, type 2 diabetes mellitus, glycosylated hemoglobin A

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria were:

  • Diagnostic of T2DM (diagnosed at least 1'5 years prior the study).
  • Presence of generalized chronic periodontitis (With at least 9 teeth present and more than 30% of locations with probing depth (PD) and clinical attachment level (CAL) ≥4mm).

Exclusion criteria included:

  • Patients who received antibiotics the last 15 days, or for a period longer than 10 days the last three months.
  • Having received non-surgical periodontal treatment within the past 6 months.
  • Pregnancy
  • Significant change of medication for diabetes during the course of the study
  • Evidence of other serious systemic disease (ASA III or IV) which may influence periodontal disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment Group

    Control Group

    Arm Description

    The Treatment Group (TG) received full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron, Acteon, Merignac, France) and Gracey curettes (Hu- Friedy, Chicago, USA).Also received Oral Hygienic Instructions

    The Control Group (CG) received periodontal prophylaxis at baseline, by removal of supragingival deposits (plaque and calculus) with ultrasonic scaler. Also received Oral Hygienic Instructions

    Outcomes

    Primary Outcome Measures

    Change from baseline in Glycosylated Hemoglobin (HbA1c)
    Serum levels glycosylated hemoglobin

    Secondary Outcome Measures

    Full Information

    First Posted
    July 11, 2015
    Last Updated
    October 18, 2016
    Sponsor
    University of Barcelona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02652026
    Brief Title
    Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients
    Official Title
    Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Barcelona

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group, Control Group.
    Detailed Description
    Background: Periodontitis and diabetes are both highly prevalent conditions, and the association between these two common diseases has been recognised by dental professionals for many years. Aim: The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). Methods: This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group (TG) (Oral Hygiene Instructions (OHI) + scaling and root planing (RAR) using ultrasound device and Gracey curettes); Control Group (CG) (OHI + supragingival removal of plaque and calculus with ultrasonic device). CG patients receive salvage therapy if a significant worsening of their periodontal status and / or metabolic observed. Periodontal assesment (probing pocket depth (PPD), gingival index (GI), and plaque index (PI)) and systemic assesment (random blood sugar, glycosylated hemoglobin (HbA1C), and salivary cytokines) and bacterial asessment at baseline and 3, 6 months after treatment is performed. There will be a single examiner, blind and calibrated to improve reproducibility. The investigators' hypothesis is that non-surgical periodontal treatment reduces HbA1c, improving metabolic control in patients with DM

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis, Type 2 Diabetes Mellitus
    Keywords
    dental root planing and scaling, periodontal disease, type 2 diabetes mellitus, glycosylated hemoglobin A

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    The Treatment Group (TG) received full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron, Acteon, Merignac, France) and Gracey curettes (Hu- Friedy, Chicago, USA).Also received Oral Hygienic Instructions
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    The Control Group (CG) received periodontal prophylaxis at baseline, by removal of supragingival deposits (plaque and calculus) with ultrasonic scaler. Also received Oral Hygienic Instructions
    Intervention Type
    Procedure
    Intervention Name(s)
    Nonsurgical periodontal treatment
    Other Intervention Name(s)
    Scaling and root planing
    Intervention Description
    Full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France) and Gracey curretes (Hu- Friedy, Chicago, USA).
    Intervention Type
    Procedure
    Intervention Name(s)
    Dental Prophylaxis
    Other Intervention Name(s)
    Removal superficial plaque
    Intervention Description
    Removal superficial plaque using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France)
    Primary Outcome Measure Information:
    Title
    Change from baseline in Glycosylated Hemoglobin (HbA1c)
    Description
    Serum levels glycosylated hemoglobin
    Time Frame
    Baseline and 6 months after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria were: Diagnostic of T2DM (diagnosed at least 1'5 years prior the study). Presence of generalized chronic periodontitis (With at least 9 teeth present and more than 30% of locations with probing depth (PD) and clinical attachment level (CAL) ≥4mm). Exclusion criteria included: Patients who received antibiotics the last 15 days, or for a period longer than 10 days the last three months. Having received non-surgical periodontal treatment within the past 6 months. Pregnancy Significant change of medication for diabetes during the course of the study Evidence of other serious systemic disease (ASA III or IV) which may influence periodontal disease.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jose López-López, Phd
    Organizational Affiliation
    University of Barcelona
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients

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