The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations (DWT)
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations: An 18-Month Randomized Clinical Trial
This randomized clinical trial will evaluate whether the decoupling with time technique improves the clinical performance of Class II posterior composite restorations compared with conventional composite restoration techniques. The study will also assess postoperative hypersensitivity and the additional operative time required to perform the decoupling with time technique. Participants will receive a posterior composite restoration and will be followed for 18 months. Clinical performance will be evaluated using the Modified United States Public Health Service (USPHS) criteria, and postoperative hypersensitivity will be assessed before treatment, 1 week after restoration placement, and at 6, 12, and 18 months. The study will help determine whether the additional time required for the decoupling with time technique is associated with improved clinical outcomes.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This randomized clinical trial will evaluate the effect of the decoupling with time technique on the clinical performance of posterior composite restorations in Class II cavities.
The study will include eligible participants requiring posterior Class II composite restorations. Participants will be randomly allocated to either the decoupling with time group or the conventional restoration group.
In the decoupling with time group, following cavity preparation, immediate dentin sealing will be performed using a universal adhesive system applied with a selective enamel-etching strategy. A conventional flowable resin composite will then be applied as an initial stress-reducing layer with a thickness of approximately 0.5-1.0 mm. A 5-minute waiting period will be allowed before completion of the composite restoration. Deep margin elevation will not be performed as part of the study protocol.
The control group will receive a conventional posterior composite restoration according to the standardized restorative protocol without the decoupling with time waiting period.
The primary outcome will be postoperative hypersensitivity, assessed using the Modified United States Public Health Service (USPHS) criteria. Hypersensitivity will be assessed pre-operatively, at 1 week after restoration placement, and at 6, 12, and 18 months after restoration placement.
The clinical performance of the restorations will be evaluated using the Modified USPHS criteria immediately after restoration placement and at 6, 12, and 18 months. The evaluated clinical parameters will include marginal integrity, fracture and retention, marginal discoloration, anatomic form, proximal contact, surface texture, radiographic evaluation, and secondary caries.
The total operative time required to complete each restoration will also be recorded in minutes using a digital stopwatch, starting from the beginning of the restorative procedure and ending upon completion of the restoration. This will allow assessment of whether the additional operative time associated with the decoupling with time technique is associated with improved clinical outcomes.
Participants will be followed for 18 months to evaluate the clinical performance of the restorations and postoperative hypersensitivity over time.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Mahetab Mahmoud Abd Elhameed, Master's candidate
- Número de telefone: 201151895247
- E-mail: mahetab.mahmoud@dentistry.cu.edu.eg
Estude backup de contato
- Nome: Omar Shaalan, Assoc. Professor of Conservati
- Número de telefone: 201122665661
- E-mail: omar.shaalan@dentistry.cu.edu.eg
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients aged between 20 and 40 years.
- Patients with posterior carious Class II lesions.
- Good oral hygiene.
- Favorable occlusion.
- Absence of deleterious oral habits.
Exclusion Criteria:
- Teeth showing signs of irreversible pulpitis.
- Teeth with secondary caries.
- Teeth with old restorations.
- Endodontically treated teeth.
- Patients with a history of adverse reactions to the test material.
- Patients with poor oral hygiene.
- Patients with systemic disease.
- Patients with severe periodontal disease.
- Uncooperative patients.
- Patients unable to attend the scheduled recall visits.
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 |
|---|---|
|
Experimental: Decoupling With Time Group
Participants assigned to this group will receive a Class II posterior composite restoration using the decoupling with time technique. Immediate dentin sealing will be performed using a universal adhesive system with a selective enamel-etching strategy, followed by application of a 0.5-1.0 mm layer of conventional flowable resin composite. A 5-minute waiting period will be allowed before completion of the composite restoration. |
Immediate dentin sealing using a universal adhesive system with a selective enamel-etching strategy, followed by application of a 0.5-1.0 mm layer of conventional flowable resin composite and a 5-minute waiting period before completion of the posterior composite restoration. |
|
Comparador Ativo: Conventional Composite Group
Participants assigned to this group will receive a conventional Class II posterior composite restoration without the decoupling with time procedure or the additional 5-minute waiting period. |
Conventional Class II posterior composite restoration without the decoupling with time procedure. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postoperative Hypersensitivity
Prazo: Pre-operatively, 1 week, 6 months, 12 months, and 18 months after restoration placement.
|
Postoperative hypersensitivity will be assessed clinically using the Modified United States Public Health Service (USPHS) criteria. The assessment will be performed before the restorative procedure and at the specified follow-up visits after restoration placement. |
Pre-operatively, 1 week, 6 months, 12 months, and 18 months after restoration placement.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Clinical Performance of Posterior Composite Restorations
Prazo: Immediately after restoration placement, 6 months, 12 months, and 18 months after restoration placement.
|
Clinical performance of the restorations will be evaluated using the Modified United States Public Health Service (USPHS) criteria. The evaluated parameters will include marginal integrity, fracture and retention, marginal discoloration, anatomic form, proximal contact, surface texture, radiographic evaluation, and secondary caries. |
Immediately after restoration placement, 6 months, 12 months, and 18 months after restoration placement.
|
|
Total Operative Time
Prazo: During the restorative procedure.
|
The total time required to complete each restorative procedure will be measured in minutes using a digital stopwatch, starting from the beginning of the restorative procedure and ending upon completion of the restoration. |
During the restorative procedure.
|
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
Palavras-chave
Outros números de identificação do estudo
- Cons-DWT-C.Perf-2026
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