- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07814716
Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars
Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars: a Randomised Clinical Trial
Visão geral do estudo
Status
Condições
Descrição detalhada
Hypomineralised second primary molars are more susceptible to post-eruptive enamel breakdown, carious lesions, hypersensitivity, and premature tooth loss. Although preformed stainless steel crowns have demonstrated favourable clinical performance in primary molars, orthodontic bands may represent a less invasive restorative approach for maintaining affected teeth until physiological exfoliation. However, their clinical performance in hypomineralised primary teeth has not been investigated.
This parallel-group randomised clinical trial will include 30 children presenting at least one hypomineralised second primary molar with extensive post-eruptive enamel breakdown or a cavitated carious lesion requiring restorative treatment. Participants will be randomly allocated to receive either an orthodontic band cemented with glass ionomer luting cement after restoration of the cavitated lesion or a preformed stainless steel crown placed using the Hall technique. When more than one tooth is eligible, one index tooth will be randomly selected for the primary analysis.
Clinical assessments will be performed immediately after treatment and at 6, 12, and 18 months. Marginal adaptation, retention, and carious lesions adjacent to the restoration margins will be assessed using modified United States Public Health Service criteria. Biofilm accumulation will be assessed using the Silness and Löe Plaque Index. Treatment acceptability will be evaluated immediately after treatment using separate questionnaires for children and caregivers. Physiological exfoliation during follow-up will be recorded separately and will not be considered treatment failure.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, Brasil, 59056-000
- Recrutamento
- Federal University of Rio Grande do Norte
-
Contato:
- Lavínia L. Costa, Master's
- Número de telefone: +55 84 998987405
- E-mail: lavinialourencocosta@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Children aged 5-10 years.
- Presence of at least one second primary molar affected by hypomineralised second primary molars requiring restorative treatment.
- Hypomineralisation associated with post-eruptive enamel breakdown involving more than one tooth surface or a cavitated carious lesion involving more than one surface and classified as code 5 or 6 according to the International Caries Detection and Assessment System.
Exclusion Criteria:
- Extensive carious lesion with subgingival margins.
- Clinical or radiographic signs of pulpal inflammation or necrosis.
- Advanced physiological root resorption indicating imminent exfoliation of the eligible tooth.
- Previous restorative treatment of the eligible tooth.
- Presence of bruxism.
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: Bands
Participants allocated to this arm will receive selective removal of softened carious dentine when carious tissue is present, followed by restoration of the cavity with conventional glass ionomer restorative cement (GC Gold Label 9).
A prefabricated stainless steel orthodontic band will then be adapted to the index tooth and cemented with glass ionomer luting cement (Meron).
|
Selective removal of softened carious dentine, when present, followed by restoration with conventional glass ionomer cement and placement of a prefabricated stainless steel orthodontic band cemented with glass ionomer luting cement.
|
|
Comparador Ativo: Crowns
articipants allocated to this arm will receive a preformed stainless steel crown placed using the Hall technique, without caries removal, local anaesthesia, or tooth preparation.
When a large cavity is present, glass ionomer restorative cement (GC Gold Label 9) will be placed at its base without prior caries removal.
The crown will be cemented with glass ionomer luting cement (Meron).
|
Placement of a preformed stainless steel crown using the Hall technique, without caries removal, local anaesthesia, or tooth preparation.
The crown will be cemented with glass ionomer luting cement.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Marginal adaptation
Prazo: 18 months after treatment
|
Marginal adaptation will be assessed using modified United States Public Health Service criteria: Alpha, continuous margin without a detectable gap; Bravo, minor discontinuity not requiring clinical intervention; and Charlie, marginal defect requiring repair or replacement.
Alpha and Bravo will be considered clinically satisfactory, whereas Charlie will be considered a failure.
|
18 months after treatment
|
|
Retention
Prazo: 18 months after treatment
|
Retention will be classified as Alpha when the orthodontic band or stainless steel crown remains firmly cemented and functional, or Charlie when it is lost or dislodged and requires recementation or replacement.
Alpha will be considered successful retention and Charlie a failure.
|
18 months after treatment
|
|
Presence of carious lesions
Prazo: 18 months after treatment
|
Carious lesions adjacent to the restoration margins will be assessed clinically and classified as Alpha when absent or Charlie when present.
Alpha will be considered clinically satisfactory and Charlie a failure.
|
18 months after treatment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Biofilm accumulation
Prazo: Immediately after treatment and at 6, 12, and 18 months
|
Biofilm accumulation will be assessed using the Silness and Löe Plaque Index, ranging from 0 to 3: 0, absence of biofilm; 1, thin biofilm film along the free gingival margin; 2, moderate accumulation within the gingival sulcus; and 3, abundant accumulation within the gingival sulcus.
Lower scores indicate less biofilm accumulation.
|
Immediately after treatment and at 6, 12, and 18 months
|
|
Child-reported treatment acceptability
Prazo: Immediately after treatment
|
Acceptability will be assessed using a five-item questionnaire.
Each item will be scored from 0 to 4, resulting in a total score ranging from 0 to 20.
The negatively worded item will be reverse-scored.
Higher total scores indicate greater treatment acceptability.
|
Immediately after treatment
|
|
Caregiver-reported treatment acceptability
Prazo: Immediately after treatment
|
Acceptability will be assessed using a five-item questionnaire.
Each item will be scored from 0 to 4, resulting in a total score ranging from 0 to 20.
Higher total scores indicate greater treatment acceptability.
|
Immediately after treatment
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Bekes K, Steffen R, Kramer N. Hypomineralised second primary molars: the Wurzburg concept. Eur Arch Paediatr Dent. 2024 Aug;25(4):597-602. doi: 10.1007/s40368-024-00913-7. Epub 2024 May 28.
- Talekar AL, Waggoner WF, Silotry TMH, Musale PK, Chaudhari GS. Prospective, Randomized, Clinical Evaluation of Preformed Zirconia Crowns and Stainless Steel Crowns on Permanent First Molars: 12-Month Results. Pediatr Dent. 2023 May 15;45(3):232-239.
- Bagattoni S, Gozzi I, Lunardon C, Gatto MR, Piana G, Lardani L. Orthodontic Bands for Preventing Post-Eruptive Breakdown in Molars Affected by Molar Incisor Hypomineralisation. Eur J Paediatr Dent. 2025 Sep 1;26(3):212-217. doi: 10.23804/ejpd.2025.2380. Epub 2025 Apr 1.
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
- 8.054.527
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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 .