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- Ensaio Clínico NCT07591948
The Effect of Low-Level Laser Therapy on Accelerating Tooth Movement and Reducing Pain During Orthodontic Treatment (LLLT)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Patients aged 15-30 years requiring fixed orthodontic treatment.
- Extraction treatment plan with bilateral canine retraction.
- Good oral hygiene and periodontal health.
- No systemic diseases or medications affecting bone metabolism.
Exclusion Criteria:
Previous orthodontic treatment.
- Smoking or alcohol consumption.
- Pregnancy or lactation.
- Use of analgesics or anti-inflammatory drugs during the study period.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Falso: The control group
The control group will receive a sham laser treatment using the same device and procedure as the LLLT group, but without emitting the laser beam.
Both the patients and the operator will be blinded to the treatment allocation
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All participants will receive standard orthodontic treatment using appliances. The type of tooth movement studied will include, (e.g., canine retraction, molar distalization). Orthodontic adjustments will be performed at intervals (e.g., every 4 weeks) by a single calibrated orthodontist to ensure consistency of force application. Force magnitude will be monitored using (e.g., strain gauges, force measuring devices) at each adjustment The LLLT group will receive laser treatment using a Ga-As-Al diode laser operating at a wavelength of 810 nm. The laser parameters will be as follows: Participants receive low-level laser therapy in addition to standard orthodontic treatment. • The laser device used is a Ga-As-Al diode laser with a wavelength of 810 nm, power output of 100 mW, and energy density of 5 J/cm² (Sousa et al., 2011). • Laser application is performed at specific time points: immediately after bracket placement, on days 3, 7, and 14, and then monthly until the end of the study.
Outros nomes:
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Comparador Ativo: Laser therapy group
The LLLT group will receive laser treatment using a Ga-As-Al diode laser operating at a wavelength of 810 nm
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All participants will receive standard orthodontic treatment using appliances. The type of tooth movement studied will include, (e.g., canine retraction, molar distalization). Orthodontic adjustments will be performed at intervals (e.g., every 4 weeks) by a single calibrated orthodontist to ensure consistency of force application. Force magnitude will be monitored using (e.g., strain gauges, force measuring devices) at each adjustment The LLLT group will receive laser treatment using a Ga-As-Al diode laser operating at a wavelength of 810 nm. The laser parameters will be as follows: Participants receive low-level laser therapy in addition to standard orthodontic treatment. • The laser device used is a Ga-As-Al diode laser with a wavelength of 810 nm, power output of 100 mW, and energy density of 5 J/cm² (Sousa et al., 2011). • Laser application is performed at specific time points: immediately after bracket placement, on days 3, 7, and 14, and then monthly until the end of the study.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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tooth movement measurement
Prazo: Tooth Movement Measurement • Method: Cephalometric radiographs will be taken at baseline, 4 weeks, and 8 weeks to assess tooth movement. Linear measurements will be made between specific cephalometric landmarks by a calibrated and blinded examiner using
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Tooth Movement Measurement • Method: Cephalometric radiographs will be taken at baseline, 4 weeks, and 8 weeks to assess tooth movement.
Linear measurements will be made between specific cephalometric landmarks by a calibrated and blinded examiner using digital imaging software.
• Parameters: The distance between the canine and second premolar is measured at baseline and at monthly intervals until the end of the study.
• Tool: Digital calipers and specialized software (e.g., OrthoAnalyzer) are used for precise measurements (Ren et al., 2003).
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Tooth Movement Measurement • Method: Cephalometric radiographs will be taken at baseline, 4 weeks, and 8 weeks to assess tooth movement. Linear measurements will be made between specific cephalometric landmarks by a calibrated and blinded examiner using
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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pain assessment
Prazo: Timing: Pain is assessed at baseline (before treatment) and at 6 hours, 24 hours, 3 days, 7 days, and 14 days after the application of orthodontic force and LLLT/sham irr
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Pain Assessment • Tool: Visual Analog Scale (VAS) is used to measure pain levels.
• Timing: Pain is assessed at baseline (before treatment) and at 6 hours, 24 hours, 3 days, 7 days, and 14 days after the application of orthodontic force and LLLT/sham irradiation.
• Procedure: Participants mark their pain level on a 10 cm line, where 0 indicates no pain and 10 indicates the worst pain imaginable
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Timing: Pain is assessed at baseline (before treatment) and at 6 hours, 24 hours, 3 days, 7 days, and 14 days after the application of orthodontic force and LLLT/sham irr
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Colaboradores e Investigadores
Patrocinador
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- (OR:06/05/2025)
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