Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition
10 de agosto de 2026 atualizado por: Wroclaw Medical University
Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition. Randomised Control Study
Evidence for the undeniable role of microscrews in anchorage control, as well as their other advantages, such as ease of insertion and removal techniques, have led to their routine use in orthodontics.
Treatment with microscrews, despite its obvious advantages, is associated with the risk of complications, the etiology of which is multifactorial.
Identifying (and subsequently controlling) as many of them as possible through research constitutes an ongoing challenge for scientists.
This pursuit defined the purpose of the present study: to determine whether a type of TISAD insertion technique - self-drilling or self-tapping - as well as the patient's sex and maxillary quadrant constitute predisposing factors for the occurrence of certain complications.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
1008
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Patients between 20 and 40 y.o. with indication for microimplant insertion in the maxilla to reinforce anchorage during en bloc distalisation.
Exclusion Criteria:
- Smoking,
- Inadequate oral hygiene
- Chronic diseases (e.g. diabetes)
- Tooth loss
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
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 |
|---|---|
|
Experimental: Insertion with self-drilling technique
Each patient received two microimplants both using self- drilling method.
In accordance with the principles of a randomized controlled trial, the choice between the self-drilling and self-tapping techniques was alternated between patients by a flip of a coin performed by a dental assistant.
|
Patients received 2 miniscrews using self-drilling method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated complications were:
|
|
Experimental: Insertion with self-tapping technique
Each patient received two microimplants both using self-tapping method.
In accordance with the principles of a randomized controlled trial, the choice between the self-drilling and self-tapping techniques was alternated between patients by a flip of a coin performed by a dental assistant.
|
Patients received 2 miniscrews using self-tapping method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated factors were:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Assessing the presence of peri-implantitis
Prazo: The occurrence of inflammation was recorded during subsequent follow-up visits (first 2 weeks after implantation and then every 6 weeks, until the distalization was completed, assessed up to 12 months).
|
Hypertrophy of the gingiva and/or redness and/or tendency to bleed was noted as the inflammation presence.
|
The occurrence of inflammation was recorded during subsequent follow-up visits (first 2 weeks after implantation and then every 6 weeks, until the distalization was completed, assessed up to 12 months).
|
|
Assessing the presence of pain lasting longer than 48 hours after implantation.
Prazo: 2 weeks after implantation
|
Two weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.
|
2 weeks after implantation
|
|
Assessing the presence of root perforation
Prazo: Immediately after implantation
|
Root perforation was diagnosed in CBCT performed after the procedure.
|
Immediately after implantation
|
|
Assesing the presence of microimplant fracture
Prazo: During implantation
|
Microimplant fracture was diagnosed during implantation, reported by the clinician.
|
During implantation
|
|
Assessing the stability of miniscrews
Prazo: During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.
|
The mobility of the miniscrews was checked clinically with cotton tweezers at each visit.
Miniscrews that could not sustain orthodontic force and required replacement because of mobility were considered failures.
|
During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de janeiro de 2015
Conclusão Primária (Real)
31 de março de 2024
Conclusão do estudo (Real)
14 de maio de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
21 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de agosto de 2026
Primeira postagem (Real)
12 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de agosto de 2026
Última verificação
1 de junho de 2024
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- SUBZ.B190.24.005
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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