Diode Laser Versus Conventional Frenectomy in Children

September 26, 2026 updated by: Burçin AVCI, Yuzuncu Yil University

Clinical Outcomes and Local Molecular Biomarker Changes in Gingival Crevicular Fluid Following Diode Laser Versus Conventional Frenectomy in Children: A Randomized Clinical Trial

This prospective, randomized, open-label, parallel-group clinical trial aims to compare diode laser frenectomy with conventional scalpel frenectomy in children aged 8-12 years with a clinical indication for maxillary labial frenectomy. Participants will be randomly allocated in a 1:1 ratio to undergo either diode laser or conventional scalpel frenectomy. Postoperative pain, wound healing, analgesic requirement, feeding difficulty, and daily comfort will be evaluated during follow-up. Gingival crevicular fluid samples will be collected at baseline and on postoperative Days 3, 7, and 14 to assess local molecular changes associated with inflammation, tissue injury, wound healing, and periodontal-alveolar remodeling using RT-qPCR.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, randomized, open-label, two-arm, parallel-group clinical trial designed to compare the postoperative clinical and local molecular responses following diode laser and conventional scalpel frenectomy in children.

Children aged 8-12 years with a clinical indication for maxillary labial frenectomy who meet the eligibility criteria will be randomly allocated in a 1:1 ratio to either the diode laser frenectomy group or the conventional scalpel frenectomy group using computer-generated randomization. Because the two surgical procedures are visibly and technically different, masking of the treating clinician and participants is not feasible.

Clinical evaluations will be performed at baseline and during postoperative follow-up. Postoperative pain will be assessed using a 0-10 Visual Analog Scale (VAS), and wound healing will be evaluated using the Landry, Turnbull and Howley Wound Healing Index. Analgesic requirement, feeding difficulty, daily comfort, and other clinical healing findings will also be recorded. Standardized intraoral photographs obtained during follow-up will provide supportive assessment of postoperative wound healing.

Gingival crevicular fluid samples will be collected from the gingival sulcus adjacent to the maxillary central incisors at baseline (Day 0) and on postoperative Days 3, 7, and 14. Two sterile paper points will be used at each sampling time point. Samples will be transferred to RNase-free tubes, transported under cold-chain conditions, and stored at -80°C until molecular analysis.

RNA isolation, complementary DNA synthesis, and RT-qPCR analyses will be performed to evaluate gene expression changes related to inflammation, tissue injury, wound healing, and local periodontal-alveolar remodeling. Planned molecular targets include IL1B, TNF, IL8, FGF2, TGFB1, an LDH metabolism-related target gene, and SOST. GAPDH and ACTB will be used as reference genes. SOST will be evaluated as a secondary exploratory marker of local periodontal-alveolar remodeling.

Changes in clinical and molecular outcomes will be evaluated over time and between treatment groups, including assessment of group, time, and group-by-time effects.

Study Type

Interventional

Enrollment (Estimated)

20

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

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

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 8-12 years.
  • Presence of a clinical indication for maxillary labial frenectomy.
  • Systemically healthy.
  • No previous frenulum surgery in the relevant region.
  • Ability to attend scheduled clinical follow-up and gingival crevicular fluid sampling visits.
  • Written informed consent provided by a parent or legal guardian.
  • Age-appropriate assent provided by the child.
  • Adequate cooperation to undergo the planned clinical procedures and gingival crevicular fluid sampling.

Exclusion Criteria:

  • Presence of a systemic disease or condition that may affect wound healing or inflammatory responses.
  • Active local infection or clinically significant inflammation in the relevant region.
  • Use of systemic antibiotics, anti-inflammatory drugs, or corticosteroids within the previous month.
  • Regular use of medications known to affect wound healing or inflammatory responses.
  • Inadequate cooperation preventing completion of the surgical procedure or gingival crevicular fluid sampling.
  • Absence of parental/legal guardian consent or child assent.
  • Inability to complete the scheduled follow-up and sampling visits.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diode Laser Frenectomy

Children aged 8-12 years assigned to this arm will undergo maxillary labial frenectomy using a diode laser. Clinical evaluations and gingival crevicular fluid sampling will be performed at baseline (Day 0) and on postoperative Days 3, 7, and 14.
Procedure: Diode Laser Frenectomy

Maxillary labial frenectomy will be performed using a Woodpecker LX16 Plus diode laser under standardized clinical conditions. The procedure will be carried out by the Department of Periodontology. Laser parameters, including wavelength, power, operating mode, fiber diameter, and application technique, will be standardized according to the final study protocol.
Active Comparator: Conventional Scalpel Frenectomy

Children aged 8-12 years assigned to this arm will undergo maxillary labial frenectomy using a conventional surgical scalpel. Clinical evaluations and gingival crevicular fluid sampling will be performed at baseline (Day 0) and on postoperative Days 3, 7, and 14.
Procedure: Conventional Scalpel Frenectomy

Maxillary labial frenectomy will be performed using a conventional surgical scalpel under standardized clinical conditions. The procedure will be carried out by the Department of Periodontology according to the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative IL1B Gene Expression in Gingival Crevicular Fluid
Time Frame: Baseline (Day 0) and postoperative Days 3, 7, and 14

Relative IL1B gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative TNF Gene Expression in Gingival Crevicular Fluid
Time Frame: Baseline (Day 0) and postoperative Days 3, 7, and 14

Relative TNF gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative IL8 Gene Expression in Gingival Crevicular Fluid
Time Frame: Baseline (Day 0) and postoperative Days 3, 7, and 14

Relative IL8 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative FGF2 Gene Expression in Gingival Crevicular Fluid
Time Frame: Baseline (Day 0) and postoperative Days 3, 7, and 14

Relative FGF2 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative TGFB1 Gene Expression in Gingival Crevicular Fluid
Time Frame: Baseline (Day 0) and postoperative Days 3, 7, and 14

Relative TGFB1 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Baseline (Day 0) and postoperative Days 3, 7, and 14
Relative LDHA Gene Expression in Gingival Crevicular Fluid
Time Frame: Baseline (Day 0) and postoperative Days 3, 7, and 14

Relative LDHA gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
Baseline (Day 0) and postoperative Days 3, 7, and 14
Postoperative Wound Healing Assessed Using the Landry, Turnbull and Howley Wound Healing Index
Time Frame: Postoperative Days 3, 7, and 14

Postoperative wound healing will be evaluated using the Landry, Turnbull and Howley Wound Healing Index. Healing will be scored from 1 (very poor healing) to 5 (excellent healing). Scores will be compared between treatment groups and across postoperative follow-up time points.
Postoperative Days 3, 7, and 14
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
Time Frame: Postoperative Days 3, 7, and 14

Postoperative pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be compared between treatment groups and across postoperative follow-up time points.
Postoperative Days 3, 7, and 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative SOST Gene Expression in Gingival Crevicular Fluid
Time Frame: Baseline (Day 0) and postoperative Days 3, 7, and 14

Relative SOST gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. SOST will be evaluated as an exploratory marker of local periodontal-alveolar remodeling following frenectomy.
Baseline (Day 0) and postoperative Days 3, 7, and 14
Postoperative Analgesic Use
Time Frame: Postoperative Days 3, 7, and 14

Postoperative analgesic use will be recorded during follow-up. The number of analgesic doses taken by each participant will be documented and compared between the diode laser and conventional scalpel frenectomy groups.
Postoperative Days 3, 7, and 14
Postoperative Feeding Difficulty
Time Frame: Postoperative Days 3, 7, and 14

Feeding difficulty will be assessed using a 0-10 numerical rating scale, where 0 indicates no difficulty with eating and 10 indicates the greatest possible difficulty. Scores will be compared between the diode laser and conventional scalpel frenectomy groups.
Postoperative Days 3, 7, and 14
Postoperative Daily Comfort
Time Frame: Postoperative Days 3, 7, and 14

Daily comfort will be assessed using a 0-10 numerical rating scale, where 0 indicates extreme discomfort and 10 indicates complete comfort. Scores will be compared between the diode laser and conventional scalpel frenectomy groups.
Postoperative Days 3, 7, and 14

Collaborators and Investigators

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

Sponsor

Yuzuncu Yil University

Investigators

  • Principal Investigator: Burçin AVCI, Van Yüzüncü Yıl Universityc

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)

November 1, 2026

Primary Completion (Estimated)

October 14, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

September 26, 2026

First Submitted That Met QC Criteria

September 26, 2026

First Posted (Actual)

October 2, 2026

Study Record Updates

Last Update Posted (Actual)

October 2, 2026

Last Update Submitted That Met QC Criteria

September 26, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VYYU-PEDO-FREN-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are not planned to be shared because the study involves pediatric participants and molecular biomarker data. De-identified aggregate results will be reported in scientific publications in accordance with applicable ethical and institutional requirements.

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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