Diode Laser Versus Conventional Frenectomy in Children
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Burçin AVCI, DDS
- Número de telefone: +905359558140
- E-mail: burcinavci@yyu.edu.tr
Locais de estudo
-
-
-
Van, Turquia (Türkiye)
- Van Yüzüncü Yıl University Faculty of Dentistry
-
Contato:
- Burçin AVCI, DDS
- Número de telefone: +905359558140
- E-mail: burcinavci@yyu.edu.tr
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
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. |
|
Comparador Ativo: 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. |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Relative IL1B Gene Expression in Gingival Crevicular Fluid
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Relative SOST Gene Expression in Gingival Crevicular Fluid
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Burçin AVCI, Van Yüzüncü Yıl Universityc
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- VYYU-PEDO-FREN-2026-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .