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

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ClinicalTrials.gov Identifier: NCT04368715
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
ŞİRİN GÜNER ONUR, Trakya University

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.

Condition or disease Intervention/treatment Phase
Frenulum; Hypertrophy Device: Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double- blinded
Primary Purpose: Treatment
Official Title: Evaluation of Pain Perception and Wound Healing After Laser-assisted Frenectomy in Pediatric Patients: a Retrospective Comparative Study
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2780 nm Er:Cr;YSGG laser treated group
Patients treated with Er:Cr;YSGG laser for labial frenectomy
Device: Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser
Experimental: 940 nm Diode laser treated group
Patients treated with 940 nm Diode laser for labial frenectomy
Device: Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser



Primary Outcome Measures :
  1. Assesment of pain perception changes after laser assisted frenectomy procedure [ Time Frame: After 3 hours, 1, 3, 7 and 14 postoperative days. ]
    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.

  2. Assessment of wound surface area measurement changes after laser assisted frenectomy procedure [ Time Frame: 1, 3, 7 and 14 postoperative days. ]
    Evalution of wound healing. Remaining wound area (RWA): The defect area was measured after 1, 3, 7 and 14 postoperative days.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368715


Sponsors and Collaborators
Trakya University
Investigators
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Study Chair: SIRIN GUNER ONUR, PhD Trakya University
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Responsible Party: ŞİRİN GÜNER ONUR, Assist. Prof. Dr., Trakya University
ClinicalTrials.gov Identifier: NCT04368715    
Other Study ID Numbers: TUTF-BAEK 2019/481
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertrophy
Pathological Conditions, Anatomical