the Objective of This Research is to Compare the Clinical Effectiveness of the Conventional Lingual Arch Space Maintainers With Three-dimensional Printed Space Maintainers.
Comparative Evaluation of the Conventional and Three-Dimensional Printed Lower Lingual Arch Space Maintainers A Randomized Clinical Trial
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Introduction and Review of literature Primary teeth serve to preserve inborn space until permanent teeth erupt, in addition they help with speech and mastication. It is appropriate to highlight the primary dentition's function as the best space maintainer for permanent teeth. It is possible that premature primary tooth loss will cause undesirable primary and permanent tooth movements, including a loss in arch length. If there is not enough arch length, it is more likely to predict malocclusions such as crowding and ectopic eruption as well as tooth impaction.
Since the largest space loss occurs within a month of losing the deciduous teeth, it is best to use a space maintainer as soon as possible after early tooth loss. Space maintainers are the orthodontic appliance of choice for preventing space loss because they preserve space within the oral cavity.
Conventional space maintainers have significant drawbacks despite their clinical effectiveness. These include the need for patient compliance, extended chairside times, multiple steps in the fabrication process, technique-sensitive impressions and lab procedures, solder failure, and caries formation at band margins.
These disadvantages in the conventional space maintainer recommend the need for more advanced appliance designs and materials, one of which is three-dimensional (3D) printing, The process involves creating 3D objects using a digitally scanned and layered design of the entire object. The design is preserved using a "Standard Tessellation Language" (STL) file.
So, the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Reham M. Assistant Professor, PhD
- Número de telefone: +966545318171
- E-mail: reham_mohamed@dent.suez.edu.eg
Estude backup de contato
- Nome: Rim M. Lecturer, PhD
- Número de telefone: +201222726567
- E-mail: rim_fathalla@dent.suez.edu.eg
Locais de estudo
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Ismailia Governorate
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Ismailia, Ismailia Governorate, Egito, 41522
- Recrutamento
- Suez Canal University
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Contato:
- Reham M. Principle investigator, Assistant professor
- Número de telefone: 0545318171
- E-mail: reham_mohamed@dent.suez.edu.eg
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Contato:
- Rim M. Co-investigator, Lecturer
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Apparently, healthy cooperative children have recently prematurely loss of more than one mandibular primary molar in any of the quadrants, full erupted mandibular first permanent molars in both sides, and whose lower permanent incisors have erupted
- The permanent successors of the lost primary molars were not expected to erupt within 6 months
- Angle's class 1 occlusion with normal primary molar relation
- Caries-free and periodontally healthy abutment teeth
- Absence of parafunctional habits or abnormal occlusion conditions such as crossbite, open bite, or deep bite.
- Children's age ranges from 7 to 9 years-old
- Radiographically, presence of permanent successors, more than one millimeter of bone covering the successor tooth germ, and/or only about one-third of the root of the permanent tooth has been formed.
- Parents and children were accepting the new treatment modality.
Exclusion Criteria:
- children exhibited poor oral hygiene, para-functional oral habits, severe crowding, space loss, and abnormal occlusion
- Extraction of primary molars exceeding three months.
- Radiographically, absence of permanent successor.
- uncooperative children
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Group I
Conventional spacemaintainer
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Two bands will be selected and checked for fit and adaptation around the distal abutment teeth, then an alginate impression will be taken and will be sent to the laboratory for fabrication
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Experimental: Group II
3D printed spacemaintainer
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An intraoral scan for the patients' lower arch will be taken using a 3D digital dental scanner.
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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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Patient satisfaction and pain experienced using the Wong-Baker Faces Test
Prazo: 9 months
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Patient satisfaction and pain experienced during conventional and digital impression and cementation will be evaluated using the Wong-Baker Faces test and subsequently recorded for clinical satisfaction at 3 months, 6 months and 9 months for both patient groups to evaluate appliance acceptance and convenience for the patients.
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9 months
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Gingival health will be evaluated using Sillness and Loe Gingival Index
Prazo: 9 months
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gingival health will be evaluated by Sillness and Loe Gingival Index Evaluation of the gingival health according to the (GI) described by (Loe and Silness, 1963): Score Criteria for the Gingival Index 0 No inflammation.
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9 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Impression taking experience for the patient assessed by 6-questions survey
Prazo: Day 1
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Questions Answer by Yes (√) or (No) ×
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Day 1
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
- 930/2024
- Organization's Unique Protocol (930/2024)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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