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Pain Perception and Wound Healing After Laser-assisted Frenectomy in Children

Primary Purpose

Frenulum; Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frenulum; Hypertrophy

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged between 8-13
  • Patients with high frenulum insertion
  • Patients without any systemic condition
  • Patients treated with either treated Er:Cr;YSGG or 940 nm diode laser for labial frenectomy
  • Patients who were followed up after day 1,7 and 14 for wound healing.
  • Patients who were followed up after 3 hours, 1,7,14 days for pain perception

Exclusion Criteria:

  • Patients with systemic condition
  • Patients who were not treated with Er:Cr;YSGG or 940 nm diode laser for labial frenectomy
  • Patients whose follow up was not properly completed

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    2780 nm Er:Cr;YSGG laser treated group

    940 nm Diode laser treated group

    Arm Description

    Patients treated with Er:Cr;YSGG laser for labial frenectomy

    Patients treated with 940 nm Diode laser for labial frenectomy

    Outcomes

    Primary Outcome Measures

    Assesment of pain perception changes after laser assisted frenectomy procedure
    Evaluation of changes in pain scores were evaluated with Wong-Baker Faces Pain Rating Scale which consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Children were asked to select the facial expression that best represented their pain. Score 1 represents there is no pain, score 5 presents moderate pain and score 10 is the higher score which represents the worst pain.
    Assessment of wound surface area measurement changes after laser assisted frenectomy procedure
    Evalution of wound healing. Remaining wound area (RWA): The defect area was measured after 1, 3, 7 and 14 postoperative days.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 23, 2020
    Last Updated
    May 1, 2020
    Sponsor
    Trakya University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04368715
    Brief Title
    Pain Perception and Wound Healing After Laser-assisted Frenectomy in Children
    Official Title
    Evaluation of Pain Perception and Wound Healing After Laser-assisted Frenectomy in Pediatric Patients: a Retrospective Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (Actual)
    Primary Completion Date
    December 2018 (Actual)
    Study Completion Date
    December 2019 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is based on the records of the patients treated for labial frenectomy with a dental laser at the Department of Padiatric Dentistry from January 2017 to December 2017. Patients younger than 15 years were included and in total 22 patients who matched the inclusion criteria were investigated in the study. The analyzed data included age, gender, frenelum insertion type, type of dental laser, and postoperative pain perception.
    Detailed Description
    This study is based on the records of the patients who received laser-assisted frenectomy treatment due to mucogingival problems at pediatric dentistry department during two year period. Twenty-two patients treated with either Er,Cr:YSGG laser 2780 nm or 940 nm diode laser were selected who fulfilled the study's inclusion criteria. The analyzed data included age, gender, frenelum insertion type, type of dental laser, postoperative pain perception and wound healing. Post-operative pain was reported with Wong-Baker Faces Pain Rating Scale after 3 hours 1, 7 and 14 days. Wound surface healing was evaluated through photography. Images were uploaded to the software and the changes in the wound area were measured in square millimeters at the day of frenectomy and on days 1, 7, and 14 postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frenulum; Hypertrophy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Double- blinded
    Allocation
    Non-Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2780 nm Er:Cr;YSGG laser treated group
    Arm Type
    Experimental
    Arm Description
    Patients treated with Er:Cr;YSGG laser for labial frenectomy
    Arm Title
    940 nm Diode laser treated group
    Arm Type
    Experimental
    Arm Description
    Patients treated with 940 nm Diode laser for labial frenectomy
    Intervention Type
    Device
    Intervention Name(s)
    Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser
    Primary Outcome Measure Information:
    Title
    Assesment of pain perception changes after laser assisted frenectomy procedure
    Description
    Evaluation of changes in pain scores were evaluated with Wong-Baker Faces Pain Rating Scale which consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Children were asked to select the facial expression that best represented their pain. Score 1 represents there is no pain, score 5 presents moderate pain and score 10 is the higher score which represents the worst pain.
    Time Frame
    After 3 hours, 1, 3, 7 and 14 postoperative days.
    Title
    Assessment of wound surface area measurement changes after laser assisted frenectomy procedure
    Description
    Evalution of wound healing. Remaining wound area (RWA): The defect area was measured after 1, 3, 7 and 14 postoperative days.
    Time Frame
    1, 3, 7 and 14 postoperative days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Aged between 8-13 Patients with high frenulum insertion Patients without any systemic condition Patients treated with either treated Er:Cr;YSGG or 940 nm diode laser for labial frenectomy Patients who were followed up after day 1,7 and 14 for wound healing. Patients who were followed up after 3 hours, 1,7,14 days for pain perception Exclusion Criteria: Patients with systemic condition Patients who were not treated with Er:Cr;YSGG or 940 nm diode laser for labial frenectomy Patients whose follow up was not properly completed
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SIRIN GUNER ONUR, PhD
    Organizational Affiliation
    Trakya University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33337937
    Citation
    Onur SG. Evaluation of Pain Perception and Wound Healing After Laser-Assisted Frenectomy in Pediatric Patients: A Retrospective Comparative Study. Photobiomodul Photomed Laser Surg. 2021 Mar;39(3):204-210. doi: 10.1089/photob.2020.4886. Epub 2020 Dec 18.
    Results Reference
    derived

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    Pain Perception and Wound Healing After Laser-assisted Frenectomy in Children

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