Pain After Diode Laser Frenectomy in Children (PED-FREN)

Afyonkarahisar Health Sciences University

Status: Not yet enrolling

Conditions: Frenectomy; Abnormal Labial Frenum Frenectomy

Treatments: Procedure: Diode Laser-Assisted Frenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07706023

25.DUS.005

25.DUS.005.DENIZ

Details and patient eligibility

About

This prospective single-group clinical study aims to evaluate postoperative pain following diode laser-assisted frenectomy in pediatric patients and to assess the agreement between different pediatric pain assessment scales. Children aged 8 to 14 years who require diode laser-assisted frenectomy will be treated according to the standard clinical protocol at the Pediatric Dentistry Clinic of Afyonkarahisar Health Sciences University. Postoperative pain will be evaluated once daily for seven consecutive days using the Wong-Baker FACES Pain Rating Scale, the Modified Emoji Pain Scale (MEPS), and gender-specific pain assessment scales. The primary objective is to characterize the time course of postoperative pain during the first postoperative week. Secondary objectives include evaluating the agreement and correlation between the different pain assessment instruments used in pediatric patients. The findings are expected to contribute to the identification of reliable pain assessment methods and to improve postoperative pain evaluation following diode laser-assisted frenectomy in children.

Full description

Diode laser-assisted frenectomy has become an increasingly preferred technique in pediatric dentistry because it provides effective soft tissue management with reduced intraoperative bleeding, minimal tissue trauma, and improved postoperative comfort. Although postoperative pain is an important determinant of treatment acceptance and patient satisfaction in children, limited evidence is available regarding the temporal pattern of pain following diode laser-assisted frenectomy and the agreement between different pediatric pain assessment instruments.

This prospective single-group clinical study was conducted at the Pediatric Dentistry Clinic of Afyonkarahisar Health Sciences University. Pediatric patients aged 8 to 14 years requiring diode laser-assisted frenectomy were consecutively enrolled after obtaining written informed consent from their parents or legal guardians. All surgical procedures were performed by the same clinician using a diode laser according to the standard clinical protocol. No comparison group was included.

The primary objective of the study is to evaluate postoperative pain during the first seven postoperative days. Pain intensity is assessed once daily using the Wong-Baker FACES Pain Rating Scale, the Modified Emoji Pain Scale (MEPS), and gender-specific pediatric pain scales. The study also aims to determine the level of agreement and correlation between these pain assessment instruments and to characterize postoperative pain trajectories throughout the first postoperative week.

The findings are expected to improve the understanding of postoperative pain following diode laser-assisted frenectomy in children and to provide evidence regarding the clinical applicability and consistency of different pediatric pain assessment tools. The results may contribute to the selection of appropriate pain assessment methods in pediatric dental practice and support postoperative pain monitoring in children undergoing soft tissue laser surgery.

Enrollment: 53 estimated patients

Sex: All

Ages: 8 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children aged 8 to 14 years.
• Patients requiring diode laser-assisted frenectomy based on clinical indication.
• American Society of Anesthesiologists (ASA) Physical Status I or II.
• Ability of the participant and parent/legal guardian to understand the study procedures.
• Written informed consent obtained from the parent or legal guardian, with assent obtained from the child when appropriate.

Exclusion criteria

• Presence of systemic diseases or medical conditions that could influence wound healing or pain perception.
• Current use of analgesic, anti-inflammatory, corticosteroid, or psychotropic medications.
• History of allergy or contraindication to local anesthetic agents.
• Acute oral infection at the surgical site.
• Previous oral soft tissue surgery in the same anatomical region.
• Inability or unwillingness to complete the postoperative pain assessment forms for seven consecutive days.
• Withdrawal of consent at any time during the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Diode Laser-Assisted Frenectomy

Experimental group

Description:

Pediatric patients underwent diode laser-assisted frenectomy according to the standard clinical protocol. Postoperative pain was assessed once daily for seven consecutive days using validated pediatric pain assessment scales.

Treatment:

Procedure: Diode Laser-Assisted Frenectomy