Diode Laser Versus Conventional Frenectomy in Children

NCT07853599 | Not Yet Recruiting

• 1 other identifier: VYYU-PEDO-FREN-2026-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frenulum; Hypertrophy; Diode Laser; Frenectomy; RT-PCR

Keywords

Frenectomy; Maxillary Labial Frenum; Inflammatory Biomarkers

Outcome Measures

Primary Outcomes (8)

• Relative IL1B Gene Expression in Gingival Crevicular Fluid

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (4)

• Relative SOST Gene Expression in Gingival Crevicular Fluid

  Baseline (Day 0) and postoperative Days 3, 7, and 14

• Postoperative Analgesic Use

  Postoperative Days 3, 7, and 14

• Postoperative Feeding Difficulty

  Postoperative Days 3, 7, and 14

• Postoperative Daily Comfort

  Postoperative Days 3, 7, and 14

Study Arms (2)

Diode Laser Frenectomy

EXPERIMENTAL

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

Conventional Scalpel Frenectomy

ACTIVE COMPARATOR

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

Interventions

Diode Laser Frenectomy PROCEDURE

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.

Diode Laser Frenectomy

Conventional Scalpel Frenectomy PROCEDURE

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.

Conventional Scalpel Frenectomy

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yüzüncü Yıl University Faculty of Dentistry

Van, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Burçin AVCI

  Van Yüzüncü Yıl Universityc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burçin AVCI, DDS

CONTACT

+905359558140; burcinavci@yyu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is open-label because the diode laser and conventional scalpel procedures are visibly and technically different, making masking of the treating clinician and participants impractical.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Eligible participants will be randomly allocated in a 1:1 ratio to two parallel treatment groups: diode laser frenectomy or conventional scalpel frenectomy. Clinical and molecular outcomes will be evaluated at baseline and during postoperative follow-up.

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 14, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)