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

Frenulum; Hypertrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368715
• Other study ID #: TUTF-BAEK 2019/481
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2019

Study information

• Verified date: May 2020
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Frenulum; Hypertrophy
• Hypertrophy

Intervention

Device:
• Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 3 hours, 1, 3, 7 and 14 postoperative days.
Primary	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.	1, 3, 7 and 14 postoperative days.