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Free Gingival Graft Adjunct With Low Level Laser Therapy

Primary Purpose

Wounds and Injuries, Transplants, Gingival Recession, Localized

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CheseeTM Diode Laser
Clinical examination
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries focused on measuring Free gingival graft, Low level laser therapy, Shrinkage

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients >18 years old
  • Patients presenting Class I or II Miller gingival recession on vital incisors in the mandibular anterior region with no caries or restoration
  • The included teeth had also keratinized gingiva <2 mm; PI and GI<1.
  • The patients had to be systemically healthy and non-smokers.

Exclusion Criteria:

  • Patients presenting active periodontal disease and probing depth >3 mm; taking medications that would interfere with the wound-healing process or that contraindicate the surgical procedure;
  • Pregnant or lactating women;
  • Patients who underwent periodontal surgery in the study area;
  • Patients with orthodontic therapy in progress were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Test group

    Control group

    Arm Description

    Free Gingival Graft (FGG) + Low Level Laser Therapy (LLLT) + Clinical Examination The test group received LLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) at the FGG sites with a wavelength of 810 nm and output power of 0.1 W, for 60 s, with an energy density of 6 J/cm2 in the continuous wave mode (spot size:0.5 cm). The laser beam was directed perpendicularly toward the tissue in the noncontact mode. The laser was irradiated at the recipient sites immediately after surgery and 1, 3, 7, and 14 days later.

    Free Gingival Graft (FGG)+Placebo Low Level Laser Therapy (PLLLT) + Clinical Examination The control group received PLLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) same as test group without pushing the start button

    Outcomes

    Primary Outcome Measures

    Graft shrinkage
    The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months.

    Secondary Outcome Measures

    Epithelization
    Epithelization was determined via bubbling test by using 3% hydrogen peroxide (H2O2). This test was carried out at 7, 14, 21, and 28 days after surgery.

    Full Information

    First Posted
    January 26, 2018
    Last Updated
    February 7, 2018
    Sponsor
    Abant Izzet Baysal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03425695
    Brief Title
    Free Gingival Graft Adjunct With Low Level Laser Therapy
    Official Title
    Free Gingival Graft Adjunct With Low Level Laser Therapy: A Randomized Placebo- Controlled Parallel Group Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    September 2017 (Actual)
    Study Completion Date
    September 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Abant Izzet Baysal 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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The present placebo-controlled parallel design clinical study was planned to determine the effect of low level laser therapy on clinical periodontal conditions and dimensions of free gingival graft as well as postoperative pain levels in the surgical area.
    Detailed Description
    Background: Shrinkage of the free gingival graft (FGG) and patient's discomfort during healing period are important concerns. Therefore, this study aimed to evaluate the effect of low level laser therapy (LLLT) in terms of enhancing wound healing, reducing graft shrinkage and postoperative pain. Methods: Thirty patients were randomly assigned to receive either FGG+ LLLT (test, n = 15) or FGG + placebo LLLT (control, n = 15). In the test group, a diode laser (aluminum-gallium-arsenide, 810 nm, 0.1 W, continuous mode, time of irradiation:60 s, energy density: 6 J/cm2, spot size:0.5 cm) was applied immediately after the FGG surgery and 1,3,7, and 14 days later. The control group received the same sequence of irradiation with the laser-off. Comparison of the graft surface areas between groups at 1st, 3rd and 6th months were made with an image-analyzing software. Complete wound epithelization, visual analogue scale (VAS) pain score of recipient site and the number of analgesic used were evaluated after the surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wounds and Injuries, Transplants, Gingival Recession, Localized, Low-Level Light Therapy
    Keywords
    Free gingival graft, Low level laser therapy, Shrinkage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized placebo-controlled parallel design
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test group
    Arm Type
    Experimental
    Arm Description
    Free Gingival Graft (FGG) + Low Level Laser Therapy (LLLT) + Clinical Examination The test group received LLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) at the FGG sites with a wavelength of 810 nm and output power of 0.1 W, for 60 s, with an energy density of 6 J/cm2 in the continuous wave mode (spot size:0.5 cm). The laser beam was directed perpendicularly toward the tissue in the noncontact mode. The laser was irradiated at the recipient sites immediately after surgery and 1, 3, 7, and 14 days later.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    Free Gingival Graft (FGG)+Placebo Low Level Laser Therapy (PLLLT) + Clinical Examination The control group received PLLLT with a diode laser (CheseeTM Diode Laser, Wuhan, China ) same as test group without pushing the start button
    Intervention Type
    Device
    Intervention Name(s)
    CheseeTM Diode Laser
    Intervention Description
    low level laser therapy was utilized adjunct with free gingival graft.
    Intervention Type
    Other
    Intervention Name(s)
    Clinical examination
    Intervention Description
    The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months. Epithelization was determined via bubbling test by using 3% hydrogen peroxide (H2O2) at 7, 14, 21, and 28 days after surgery.
    Primary Outcome Measure Information:
    Title
    Graft shrinkage
    Description
    The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months.
    Time Frame
    1-, 3-, and 6-months after FGG surgery
    Secondary Outcome Measure Information:
    Title
    Epithelization
    Description
    Epithelization was determined via bubbling test by using 3% hydrogen peroxide (H2O2). This test was carried out at 7, 14, 21, and 28 days after surgery.
    Time Frame
    7, 14, 21, and 28 days after FGG surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients >18 years old Patients presenting Class I or II Miller gingival recession on vital incisors in the mandibular anterior region with no caries or restoration The included teeth had also keratinized gingiva <2 mm; PI and GI<1. The patients had to be systemically healthy and non-smokers. Exclusion Criteria: Patients presenting active periodontal disease and probing depth >3 mm; taking medications that would interfere with the wound-healing process or that contraindicate the surgical procedure; Pregnant or lactating women; Patients who underwent periodontal surgery in the study area; Patients with orthodontic therapy in progress were excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    AIBU Faculty of Dentistry
    Organizational Affiliation
    Abant Izzet Baysal University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Free Gingival Graft Adjunct With Low Level Laser Therapy

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