- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00836797
Radiographic Assessment of Bone Regeneration in Alveolar Sockets With PLGA Scaffold
Phase I Radiographic Assessment of Bone Regeneration in Alveolar Sockets With PLGA Bioscaffold After Teeth Extraction
Visão geral do estudo
Status
Descrição detalhada
A case controlled study design is adopted. Patients who will be having extraction of any tooth including surgical extraction but not due to any periodontal reasons are selected. Consent of the patient will be taken for the procedure and all the effects and possibilities will be explained to the patients. Extraction will be done and scaffold material will be placed inside the socket. Sockets with the scaffold will be the variable studied and the sockets without scaffold placed inside the sockets will be the control group. An OPG x ray will be taken with the head position standardized by a positioning device. A second x-ray will be taken following the same technique after two months (for assessment of bone healing as is practiced normally) and a final x-ray will be taken after 3 months of the first x-ray (normally done in clinics for assessment of socket prior to implantation.
The OPG x ray is taken with the patient biting on a bite plate device fabricated with an embedded wire inside which is radiopague. If the distance from the wire line (the occlusal plane) to the alveolar bony height is 'a' and if the actual diameter of the metallic ball is 'b' and radiographic ball diameter is 'c' then the equation ( a×b)/c will give us the distance of the alveolar bony crest from the wire line. The measurements taken will determine if the distance of the alveolar crest from the wire line remained the same or has increased. If it remains the same, it will suggest that the scaffold material had maintained the socket and prevented alveolar bone resorption, but if the distance increases that will indicate vertical loss of alveolar bone and the extent measured can be compared with sockets without the support of an immediate post-extraction scaffold. This study will determine firstly whether the scaffold allows for bone regeneration in human alveolar sockets in the normal time and secondly whether it would help to preserve alveolar bone height as compared to cases without scaffold.
Consent of the selected patient will be taken for the procedure. Extraction will be done and scaffold material will be placed inside the socket. Socket with the scaffold will be our cases and the socket without scaffold will be the control group in multiple extraction cases. Radiographic assessment will be done to assess bone regeneration at the prescribed pre-extraction stage, at the 2 months bone healing stage and at the 3 months (from initial extraction) implant planning stage as in usual clinical practice . Assessment of the bony height is made with the prescribed formula from the radiographs taken and comparison will be made with the control cases. The following are the criteria for selecting the patients.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Under going extraction of tooth including the surgical extraction.
- Healthy individual with no known medical problems.
- Not allergic to foreign body.
- Extractions which are not due to periodontal causes.
Exclusion Criteria:
- Bony disease.
- Bleeding disorder.
- Allergic to foreign body.
- Mentally retarded persons.
- Diabetic patient.
- Drug addict.
- Extraction due to periodontal disease.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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1 Case with scaffold
This group of patients will be having a placement of PLGA bioscaffold in the alveolar socket after teeth extraction
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2 Control without scaffold
The Alveolar socket will be left to heal and no treatment/scaffold placement will be done
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Preservation of Alveolar height
Prazo: 3 months
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3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tai Weng Fan Victor, BDS FDSRCS, National University of Singapore, Faculty of Dentistry
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- BSI-001-VF
- DSRB A/06/404
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