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
About this trial
This is an interventional treatment trial for Frenulum; Hypertrophy
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
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
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
Learn more about this trial
Pain Perception and Wound Healing After Laser-assisted Frenectomy in Children
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