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

May 1, 2020 updated by: ŞİRİN GÜNER ONUR, Trakya University

Evaluation of Pain Perception and Wound Healing After Laser-assisted Frenectomy in Pediatric Patients: a Retrospective Comparative Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 3 hours, 1, 3, 7 and 14 postoperative days.
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.
1, 3, 7 and 14 postoperative days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trakya University

Investigators

  • Study Chair: SIRIN GUNER ONUR, PhD, Trakya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (ACTUAL)

April 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2020

Last Update Submitted That Met QC Criteria

May 1, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUTF-BAEK 2019/481

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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