Clinical trial NCT04368715: 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
Overall status: COMPLETED
Phase: NA
Conditions: Frenulum; Hypertrophy
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assesment of pain perception changes after laser assisted frenectomy procedure
timeFrame: After 3 hours, 1, 3, 7 and 14 postoperative days.
measure: Assessment of wound surface area measurement changes after laser assisted frenectomy procedure
timeFrame: 1, 3, 7 and 14 postoperative days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Trakya University
name: SIRIN GUNER ONUR, PhD
role: STUDY_CHAIR
References:
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.