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Laser Assisted Nonsurgical Periodontal Treatment

Primary Purpose

Chronic Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasonics
Gracey Curettes
Er:YAG Laser
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring chronic periodontitis, laser

Eligibility Criteria

28 Years - 58 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Greater than 25 years, Clinical diagnosis of moderate to advanced chronic periodontitis, Pocket depth ≥ 5 mm or clinic attachment level ≥ 4 mm at least in two interproximal areas (not on the same tooth), Along with very good oral hygiene scores (GI≤1and PI≤1), At least 4 teeth in each quadrant, Teeth with subgingival plaque sample is collected has no restoration or prothesis

Exclusion Criteria:

Periodontal treatment ( root planning or surgical periodontal treatment) had done before, Systemic disease that could influence the outcome of periodontal therapy, Prophylaxis regime mandatory during periodontal treatment, Use of any drug that could influence the outcome of periodontal therapy, Use of antibiotics within the last 3 months, Use of anti-inflammatory drugs within the last 3 months, Use of removable prothesis Pregnancy, lactation or use of hormone contraceptives, Smoking

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Ultrasonics & Gracey Curettes

    Ultrasonics & Gracey Curettes & Laser

    Arm Description

    Scaling and root planning is done with ultrasonics and gracey curettes in 24 hours with two visits.

    Scaling and root planning is done with ultrasonics, gracey curettes and Er:YAG laser in 24 hours with two visits.

    Outcomes

    Primary Outcome Measures

    Probing Pocket Depth 3
    to measure the probing pocket depth of all teeth
    Clinic Attachment Level 3
    to measure the Clinic Attachment Level of all teeth
    Subgingival Plak Sample 1
    quantitative changes on red complex bacterias
    Probing Pocket Depth 6
    to measure theProbing Pocket Depth of all teeth
    Clinic Attachment Level 6
    to measure the Clinic Attachment Level of all teeth
    Subgingival Plak Sample 3
    quantitative changes on red complex bacterias
    Subgingival Plak Sample 6
    quantitative changes on red complex bacterias

    Secondary Outcome Measures

    Bleeding On Probing 3
    to record the Bleeding On Probing of all teeth
    Bleeding On Probing 6
    to record the Bleeding On Probing of all teeth
    Plak Index 3
    to record the plak index of all teeth
    Plak Index 6
    to record the plak index of all teeth

    Full Information

    First Posted
    November 7, 2017
    Last Updated
    December 29, 2017
    Sponsor
    Bezmialem Vakif University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03387371
    Brief Title
    Laser Assisted Nonsurgical Periodontal Treatment
    Official Title
    Clinical and Microbiologic Effects of Nonsurgical Periodontal Treatment Combined With an Erbium: Yttrium Aluminium Garnet Laser
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 18, 2016 (Actual)
    Primary Completion Date
    January 20, 2018 (Anticipated)
    Study Completion Date
    January 20, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bezmialem Vakif University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Periodontitis is a chronic inflammatory disease caused by mixed infections with the subgingival microbiota being organized as a biofilm that, if untreated, may result in breakdown of the periodontal tissues in susceptible individuals. Evidence from intervention studies shows that mechanical root debridement significantly improves periodontal health by halting the progression of periodontal tissue breakdown. In order to improve effectiveness and efficacy of the removal of the subgingival biofilm, Er:YAG laser therapy has recently been recommended as an alternative to conventional scaling procedures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    chronic periodontitis, laser

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasonics & Gracey Curettes
    Arm Type
    Active Comparator
    Arm Description
    Scaling and root planning is done with ultrasonics and gracey curettes in 24 hours with two visits.
    Arm Title
    Ultrasonics & Gracey Curettes & Laser
    Arm Type
    Experimental
    Arm Description
    Scaling and root planning is done with ultrasonics, gracey curettes and Er:YAG laser in 24 hours with two visits.
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasonics
    Intervention Description
    ultrasonic scalers
    Intervention Type
    Device
    Intervention Name(s)
    Gracey Curettes
    Intervention Description
    Spesific gracey curettes
    Intervention Type
    Device
    Intervention Name(s)
    Er:YAG Laser
    Intervention Description
    2940 nm wavelenght Er:YAG laser
    Primary Outcome Measure Information:
    Title
    Probing Pocket Depth 3
    Description
    to measure the probing pocket depth of all teeth
    Time Frame
    3. month
    Title
    Clinic Attachment Level 3
    Description
    to measure the Clinic Attachment Level of all teeth
    Time Frame
    3. month
    Title
    Subgingival Plak Sample 1
    Description
    quantitative changes on red complex bacterias
    Time Frame
    1. month
    Title
    Probing Pocket Depth 6
    Description
    to measure theProbing Pocket Depth of all teeth
    Time Frame
    6. month
    Title
    Clinic Attachment Level 6
    Description
    to measure the Clinic Attachment Level of all teeth
    Time Frame
    6. month
    Title
    Subgingival Plak Sample 3
    Description
    quantitative changes on red complex bacterias
    Time Frame
    3. month
    Title
    Subgingival Plak Sample 6
    Description
    quantitative changes on red complex bacterias
    Time Frame
    6. month
    Secondary Outcome Measure Information:
    Title
    Bleeding On Probing 3
    Description
    to record the Bleeding On Probing of all teeth
    Time Frame
    3. month
    Title
    Bleeding On Probing 6
    Description
    to record the Bleeding On Probing of all teeth
    Time Frame
    6. month
    Title
    Plak Index 3
    Description
    to record the plak index of all teeth
    Time Frame
    3. month
    Title
    Plak Index 6
    Description
    to record the plak index of all teeth
    Time Frame
    6. month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Years
    Maximum Age & Unit of Time
    58 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Greater than 25 years, Clinical diagnosis of moderate to advanced chronic periodontitis, Pocket depth ≥ 5 mm or clinic attachment level ≥ 4 mm at least in two interproximal areas (not on the same tooth), Along with very good oral hygiene scores (GI≤1and PI≤1), At least 4 teeth in each quadrant, Teeth with subgingival plaque sample is collected has no restoration or prothesis Exclusion Criteria: Periodontal treatment ( root planning or surgical periodontal treatment) had done before, Systemic disease that could influence the outcome of periodontal therapy, Prophylaxis regime mandatory during periodontal treatment, Use of any drug that could influence the outcome of periodontal therapy, Use of antibiotics within the last 3 months, Use of anti-inflammatory drugs within the last 3 months, Use of removable prothesis Pregnancy, lactation or use of hormone contraceptives, Smoking

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31050949
    Citation
    Zengin Celik T, Saglam E, Ercan C, Akbas F, Nazaroglu K, Tunali M. Clinical and Microbiological Effects of the Use of Erbium: Yttrium-Aluminum-Garnet Laser on Chronic Periodontitis in Addition to Nonsurgical Periodontal Treatment: A Randomized Clinical Trial-6 Months Follow-Up. Photobiomodul Photomed Laser Surg. 2019 Mar;37(3):182-190. doi: 10.1089/photob.2018.4510. Epub 2019 Feb 21.
    Results Reference
    derived

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    Laser Assisted Nonsurgical Periodontal Treatment

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