Pain After Diode Laser Frenectomy in Children

NCT07706023 | Not Yet Recruiting

• 2 other identifiers: 25.DUS.005.DENIZ25.DUS.005
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abnormal Labial Frenum Frenectomy; Frenectomy

Keywords

Diode Laser; Laser Frenectomy; Pediatric Dentistry; Postoperative Pain; Pain Assessment; Wong-Baker FACES Pain Rating Scale; Modified Emoji Pain Scale; Children; Oral Surgery; Frenulum Abnormalities

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale

  Postoperative pain intensity assessed using the Wong-Baker FACES Pain Rating Scale.

  Daily for 7 consecutive postoperative days

• Postoperative Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale

  Postoperative pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale. Participants recorded their pain level once daily during the first seven postoperative days.

  Daily for 7 days after diode laser-assisted frenectomy

Study Arms (1)

Diode Laser-Assisted Frenectomy

EXPERIMENTAL

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.

Procedure: Diode Laser-Assisted Frenectomy

Interventions

Diode Laser-Assisted Frenectomy PROCEDURE

Diode laser-assisted frenectomy was performed under local anesthesia using a standardized surgical protocol by the same experienced pediatric dentist. Following the procedure, participants received routine postoperative care and were instructed to record postoperative pain 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.

Diode Laser-Assisted Frenectomy

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Science University

Afyonkarahisar, 03300, Turkey (Türkiye)

Location

Related Publications (1)

• Armfield JM. Towards a better understanding of dental anxiety and fear: Cognitions vs. experiences. Eur J Oral Sci. 2010;118(3):259-264. Klingberg G, Broberg AG. Dental fear/anxiety and dental behaviour management problems in children and adolescents. Int J Paediatr Dent. 2007;17(6):391-406. Locker D, Liddell A, Shapiro D. Diagnostic categories of dental anxiety: A population-based study. Behav Res Ther. 1999;37(3):301-307. Remi RV, Anantharaj A, Praveen P, et al. Advances in pediatric dentistry: New approaches to pain control and anxiety reduction in children. J Dent Anesth Pain Med. 2023;23(6):303-315. Eymirli PS, Turgut MD. Laser application in pediatric dentistry: A literature update. Ankara Med J. 2019.

  RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Özgür Doğan, Assoc. Prof. Dr.

  Afyonkarahisar Health Science University

  STUDY DIRECTOR

Central Study Contacts

Özgür Doğan, Assoc. Prof. Dr.

CONTACT

905052777520; ozgurdogan1984@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: All enrolled participants received the same intervention (diode laser-assisted frenectomy). There was no comparison or control group. Postoperative pain was assessed once daily for seven consecutive days using multiple validated pediatric pain assessment scales.

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)