Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Diode Laser Versus Conventional Frenectomy in Children

26. september 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

8 år til 12 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative IL1B Gene Expression in Gingival Crevicular Fluid
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative SOST Gene Expression in Gingival Crevicular Fluid
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Yuzuncu Yil University

Efterforskere

  • Ledende efterforsker: Burçin AVCI, Van Yüzüncü Yıl Universityc

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

14. oktober 2027

Studieafslutning (Anslået)

30. november 2027

Datoer for studieregistrering

Først indsendt

26. september 2026

Først indsendt, der opfyldte QC-kriterier

26. september 2026

Først opslået (Faktiske)

2. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VYYU-PEDO-FREN-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner