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

NCT04368715 | Completed

• 1 other identifier: TUTF-BAEK 2019/481
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Frenulum; Hypertrophy

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

2780 nm Er:Cr;YSGG laser treated group

EXPERIMENTAL

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

940 nm Diode laser treated group

EXPERIMENTAL

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

Interventions

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

2780 nm Er:Cr;YSGG laser treated group; 940 nm Diode laser treated group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Related Publications (1)

• 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.

  PMID: 33337937 DERIVED

MeSH Terms

Conditions

Hypertrophy

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• SIRIN GUNER ONUR, PhD

  Trakya University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double- blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 30, 2020
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share