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Diode Laser Versus Conventional Frenectomy in Children

26 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

8 jaar tot 12 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Actieve vergelijker: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Relative IL1B Gene Expression in Gingival Crevicular Fluid
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Relative SOST Gene Expression in Gingival Crevicular Fluid
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Yuzuncu Yil University

Onderzoekers

  • Hoofdonderzoeker: Burçin AVCI, Van Yüzüncü Yıl Universityc

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

14 oktober 2027

Studie voltooiing (Geschat)

30 november 2027

Studieregistratiedata

Eerst ingediend

26 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 september 2026

Eerst geplaatst (Werkelijk)

2 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

26 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • VYYU-PEDO-FREN-2026-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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