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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07792720
Effect of Advanced PRF and Hyaluronic Acid on Dental Implant Healing
Clinical Efficacy of A-PRF With Hyaluronic Acid" in Enhancing Bone Formation in Dental Implantation
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Samar A Salamah, BDS
- Número de telefone: +967777277949
- E-mail: samarali777277949@gmail.com
Locais de estudo
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Sana'a
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Sanaa, Sana'a, Iémen
- Recrutamento
- Beauty Smile Dental Center
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Contato:
- Samar A Salamah, BDS
- Número de telefone: +967777277949
- E-mail: samarali777277949@gmail.com
-
Contato:
- Samar A Salamah, BDS
- E-mail: samarali777277949@gmail.com
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Adults aged 18-65 years.
Patients requiring delayed dental implant placement in a posterior mandibular edentulous site
Sufficient residual alveolar bone height and width to permit conventional implant placement without the need for simultaneous guided bone regeneration (GBR), ridge augmentation, or other bone-grafting procedures.
Good general health or a medically controlled and stable systemic condition compatible with elective implant surgery and not expected to materially compromise wound or bone healing.
Non-smokers with no current use of tobacco products.
Acceptable oral hygiene and a periodontal condition compatible with implant surgery following any required professional treatment and reassessment.
Ability and willingness to undergo the required clinical and radiographic assessments, including CBCT examinations at baseline and at the 6-month follow-up.
Ability and willingness to attend the scheduled follow-up visits and comply with the study procedures.
Provision of written informed consent before study participation.
Exclusion Criteria:
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Any uncontrolled systemic disease or medical condition that conensions for conventional implant placement without augmentation.
Requirement for immediate implant placement, simultaneous guided bone regeneration, ridge augmentation, or any other adjunctive bone-grafting procedure.
Inability or unwillingness to complete the required 6-month clinical and radiographic follow-up.traindicates elective implant surgery or may substantially impair wound or bone healing, including uncontrolled diabetes mellitus.
Immunocompromised status or current systemic immunosuppressive therapy.
Current or previous use of oral or parenteral bisphosphonates or other antiresorptive medications associated with a risk of medication-related osteonecrosis of the jaw.
Pregnancy at the time of screening or enrollment.
Unresolved active periodontal disease or active local infection involving the intended implant site, including suppuration.
Inadequate oral hygiene that persists after professional oral-hygiene instruction, necessary periodontal treatment, and reassessment.
Insufficient residual alveolar bone dim
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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Experimental: Dental Implant + A-PRF and Hyaluronic Acid
Participants receive delayed dental implant placement with adjunctive application of advanced platelet-rich fibrin (A-PRF) combined with hyaluronic acid at the implant site.
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A dental implant was surgically placed into a healed edentulous site using a standardized delayed-placement protocol.
This procedure was performed in both the test and control groups.
Autologous advanced platelet-rich fibrin (A-PRF) was prepared from the participants' venous blood using a standardized centrifugation protocol and applied at the dental implant site.
In the test group, A-PRF was used in combination with hyaluronic acid as an adjunct to delayed dental implant placement.
In the test group, 1.5% hyaluronic acid is combined with autologous advanced platelet-rich fibrin (A-PRF) and applied locally at the dental implant site during delayed dental implant placement.
The control group does not receive hyaluronic acid.
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Comparador Ativo: Dental Implant Alone
Participants receive delayed dental implant placement without adjunctive A-PRF or hyaluronic acid.
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A dental implant was surgically placed into a healed edentulous site using a standardized delayed-placement protocol.
This procedure was performed in both the test and control groups.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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CBCT-Derived Peri-Implant Bone Volume
Prazo: Baseline and 6 months after implant placement
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The peri-implant bone volume will be assessed using cone-beam computed tomography (CBCT) at baseline and 6 months after dental implant placement.
Changes in bone volume between baseline and the 6-month follow-up will be evaluated and compared between the test and control groups.
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Baseline and 6 months after implant placement
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CBCT-Derived Peri-Implant Radiographic Density
Prazo: Baseline and 6 months after implant placement
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Peri-implant radiographic density will be assessed using cone-beam computed tomography (CBCT) at baseline and 6 months after dental implant placement.
Changes in radiographic density between baseline and the 6-month follow-up will be evaluated and compared between the test and control groups.
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Baseline and 6 months after implant placement
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Implant Stability Quotient (ISQ)
Prazo: At implant placement and 6 months after implant placement
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Implant stability will be assessed using resonance frequency analysis and expressed as Implant Stability Quotient (ISQ) values.
ISQ will be measured at the time of implant placement and at the 6-month follow-up, and changes will be compared between the test and control groups.
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At implant placement and 6 months after implant placement
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Dental Implant Survival Rate at 6 Months
Prazo: Up to 6 months after implant placement
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Implant survival will be assessed by determining whether the dental implant remains in situ and clinically functional without removal during the 6-month follow-up period.
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Up to 6 months after implant placement
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Samar A salamah, BDS, Sana'a University
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
Outros números de identificação do estudo
- OMFS-033\06\2025
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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