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Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics

Primary Purpose

Chronic Periodontitis, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Periodontal ultrasonic debridement
Debridement plus low-level laser therapy
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring periodontal treatment, low-level light therapy

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age ≥ 35; diagnosis of type 2 diabetes for ≥ 5 years; diabetes treatment with oral hypoglycemic agents or insulin supplementation and diet; glycated hemoglobin (HbA1c) levels from 6.5% to 11%; at least 15 teeth (excluding third molars and teeth indicated for extraction); and moderate to severe generalized chronic periodontitis.

Exclusion Criteria:

  • The exclusion criteria were: medical conditions that required prophylactic antimicrobial coverage; periodontal mechanical therapy in the previous 6 months; antimicrobial therapies in the previous 6 months; anti-inflammatory therapies in the previous 6 months; systemic conditions other than diabetes that could affect the progression of chronic periodontitis; current use of medication that could interfere with periodontal response to treatment; pregnancy or lactation; and smoking.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Active Comparator

    Arm Label

    Periodontal ultrasonic debridement

    Low-level laser therapy

    Arm Description

    Periodontal pockets received ultrasonic periodontal debridement intervention.

    Periodontal pockets received ultrasonic periodontal debridement plus low-level laser therapy intervention.

    Outcomes

    Primary Outcome Measures

    Probing depth change from baseline to 30, 90, and 180 days through periodontal probing

    Secondary Outcome Measures

    Clinical attachment level change from baseline to 30, 90, and 180 days through periodontal probing
    Gingival recession change from baseline to 30, 90, and 180 days through periodontal probing
    Bleeding on probing change from baseline to 30, 90, and 180 days through periodontal probing
    Plaque index change from baseline to 30, 90, and 180 days through periodontal probing

    Full Information

    First Posted
    June 10, 2016
    Last Updated
    July 8, 2016
    Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho
    Collaborators
    Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02817152
    Brief Title
    Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics
    Official Title
    Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics: Split-mouth Double-blind Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (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
    Universidade Estadual Paulista Júlio de Mesquita Filho
    Collaborators
    Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients.
    Detailed Description
    The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients. Twenty poorly-controlled type 2 diabetic patients with moderate to severe generalized chronic periodontitis were selected. Two periodontal pockets with Probing Depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm received ultrasonic periodontal debridement (UPD) only (control group) or UPD with LLLT (test group). Clinical measures, such as PD, CAL, Gingival Recession (GR), Bleeding on Probing (BoP), and Plaque Index (PI), were collected and compared at baseline, 30, 90, and 180 days. The adjunct application of LLLT to UPD had no additional benefits for PD reduction and CAL gain, meaning that both investigated therapies were efficient for the treatment of chronic periodontitis in type 2 diabetics. Nevertheless, additional LLLT application showed better results for GR then UPD only.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis, Diabetes Mellitus
    Keywords
    periodontal treatment, low-level light therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Periodontal ultrasonic debridement
    Arm Type
    Sham Comparator
    Arm Description
    Periodontal pockets received ultrasonic periodontal debridement intervention.
    Arm Title
    Low-level laser therapy
    Arm Type
    Active Comparator
    Arm Description
    Periodontal pockets received ultrasonic periodontal debridement plus low-level laser therapy intervention.
    Intervention Type
    Procedure
    Intervention Name(s)
    Periodontal ultrasonic debridement
    Other Intervention Name(s)
    periodontal debridement, ultrasonic debridement
    Intervention Description
    Periodontal pockets received periodontal ultrasonic debridement intervention.
    Intervention Type
    Device
    Intervention Name(s)
    Debridement plus low-level laser therapy
    Other Intervention Name(s)
    low-level light therapy, low-power laser therapy, low-intensity laser therapy
    Intervention Description
    Ultrasonic debridement plus low-level laser therapy.
    Primary Outcome Measure Information:
    Title
    Probing depth change from baseline to 30, 90, and 180 days through periodontal probing
    Time Frame
    baseline, 30 days, 90 days, 180 days
    Secondary Outcome Measure Information:
    Title
    Clinical attachment level change from baseline to 30, 90, and 180 days through periodontal probing
    Time Frame
    baseline, 30 days, 90 days, 180 days
    Title
    Gingival recession change from baseline to 30, 90, and 180 days through periodontal probing
    Time Frame
    baseline, 30 days, 90 days, 180 days
    Title
    Bleeding on probing change from baseline to 30, 90, and 180 days through periodontal probing
    Time Frame
    baseline, 30 days, 90 days, 180 days
    Title
    Plaque index change from baseline to 30, 90, and 180 days through periodontal probing
    Time Frame
    baseline, 30 days, 90 days, 180 days
    Other Pre-specified Outcome Measures:
    Title
    Glycated hemoglobin
    Time Frame
    Baseline, 180 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age ≥ 35; diagnosis of type 2 diabetes for ≥ 5 years; diabetes treatment with oral hypoglycemic agents or insulin supplementation and diet; glycated hemoglobin (HbA1c) levels from 6.5% to 11%; at least 15 teeth (excluding third molars and teeth indicated for extraction); and moderate to severe generalized chronic periodontitis. Exclusion Criteria: The exclusion criteria were: medical conditions that required prophylactic antimicrobial coverage; periodontal mechanical therapy in the previous 6 months; antimicrobial therapies in the previous 6 months; anti-inflammatory therapies in the previous 6 months; systemic conditions other than diabetes that could affect the progression of chronic periodontitis; current use of medication that could interfere with periodontal response to treatment; pregnancy or lactation; and smoking.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mauro P Santamaria, DDS, MS, PhD
    Organizational Affiliation
    UPECLIN HC FM Botucatu Unesp
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    20932157
    Citation
    Aykol G, Baser U, Maden I, Kazak Z, Onan U, Tanrikulu-Kucuk S, Ademoglu E, Issever H, Yalcin F. The effect of low-level laser therapy as an adjunct to non-surgical periodontal treatment. J Periodontol. 2011 Mar;82(3):481-8. doi: 10.1902/jop.2010.100195. Epub 2010 Oct 8.
    Results Reference
    result

    Learn more about this trial

    Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics

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