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

July 10, 2026 updated by: Özgür Doğan, Afyonkarahisar Health Sciences University

Postoperative Pain Assessment Following Diode Laser-Assisted Frenectomy in Pediatric Patients: A Prospective Single-Group Clinical Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Afyonkarahisar, Turkey (Türkiye), 03300
        • Afyonkarahisar Health Science University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diode Laser-Assisted Frenectomy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale
Time Frame: Daily for 7 consecutive postoperative days
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
Time Frame: Daily for 7 days after diode laser-assisted frenectomy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Afyonkarahisar Health Sciences University

Investigators

  • Study Director: Özgür Doğan, Assoc. Prof. Dr., Afyonkarahisar Health Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 10, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 10, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25.DUS.005.DENIZ
  • 25.DUS.005 (Other Grant/Funding Number: Afyonkarahisar Health Science University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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