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- Ensaio Clínico NCT04043754
Platelet-rich Fibrin and Autogenous Bone vs Membrane and Autogenous Bone in Intrabony Defects
Periodontal Regeneration With Platelet-rich Fibrin (Prf) and Autogenous Bone Graft (Abg) Versus Membrane and Abg in the Treatment of Intrabony Periodontal Defects a Longitudinal Randomized Control Clinical Study
Currently, the most positive documented outcomes of periodontal regenerative therapy (PRT) in intrabony defects (IBDs) have been achieved with a combination of bone grafts ( BGs) and a regeneration material like membranes in guided tissue regeneration ( GTR) technique. Among the graft materials only autogenous bone grafts ( ABGs).and demineralized freeze-dried bone allografts (DFDBA), are considered regenerative materials.
Polypeptide growth factors revealed a potential application in PRT periodontal because are the biological mediators during wound healing and regeneration and autologous platelet concentrates ( PC) constitute a safe and convenient approach to deliver them.
Among PC, platelet-rich fibrin ( PRF) belongs to a group of second-generation blood autologous products prepared by peripheral blood centrifugation without any nonclotting agent, so to obtain a dense three-dimensional clot architecture that concentrates platelets, fibrin, leukocytes, cytokines, and sustain cellular migration. This clot is then compressed to obtain elastic and very strong membranes that can be used directly as membranes or as an agent, after chopping, alone or in combination with BGs.
Several studies demonstrate that PRF is effective in promoting bone regeneration (BR) when used alone or in combination with BG during oral/ periodontal surgery.
To date, there are very few published clinical controlled trials that compare the results of PRF + BGs to the outcomes of PRF / BG alone in the treatment of IBDs and no study about PRF + ABG in the same defects. Only one case report tested the use of PRF + ABG mixed with bovine hydroxyapatite in the treatment of insufficient alveolar ridge width in aesthetic area. The aim of the present study is to verify if the combined use of PRF + ABG in the management of IBDs may be a treatment modality clinically "not inferior" to that with Membrane + ABG.
Visão geral do estudo
Status
Condições
Descrição detalhada
This is a prospective, randomized and controlled clinical trial designed to evaluate the clinical and radiographic outcomes 12 months after two treatment modalities of IBDs: PRF + ABG into defects in the test subjects( TS); membrane + ABG in the control subjects ( CS). The patients enrolled exhibit unfavourable IBDs and all experimental sites will be accessed with a simplified papilla preservation flap ( SPPF) procedure. The filling material (ABG) is common to both treatments: therefore, the investigation will focus on the addictive effect of PRF used in place of MEMBRANE. MEMBRANE is chosen as the active control ( AC) as it is currently considered as the biological "gold standard" agent for the treatment of IBDs.
A non-inferiority trial ( NIT) is designed to prove that using PRF instead of MEMBRANE could achieve a similar result, reducing the treatment's cost and allowing the clinicians to use autogenous material only.
An AC (comparator) is present, but the investigators do not include a third experimental arm, a group of IBDs treated using Open Flap Debridement ( OFD) alone, as it is widely accepted in NITs.
The estimate of the AC effect vs. placebo is assumed from a recent meta-analysis, by the Lower Bound of a 95% Confidence Interval ( CI) of the mean of MEMBRANE + ABG, while an OFD estimate from the corresponding 95%.. The difference between estimates is set as the added benefit of the AC and as a ground for the assay sensitivity.
44 patients affected by moderate-to-severe chronic periodontitis, will be selected for the study. Each patient will participate in the study with a single experimental site. The participants will receive verbal and written information and they will sign a consent form approved by the Ethical Committee of the G. DAnnunzio University of Chieti - medical faculty. The study protocol is in accordance with the Declaration of Helsinki of 1975, revised in Tokyo in 2004. Four months before the surgical treatment, all 44 patients will undergo SRP by ultrasonic instruments and hand curettes and motivational instructions on oral home care.
Non-inferiority margin. A reliable estimate of the expected clinical attachment level ( CAL) gain from an MEMBRANE+ ABG treatment is drawn from a recent meta-analysis, reporting on 548 IBDs in 434 patients.
By literature, CAL gain obtainable by OFD surgical treatments alone is 2.47 mm. The differential effect of using MEMBRANE amounts about 1 .
Each defect will be assigned a defect number and will be randomly allocated to one of the two treatment regimens. Assignment will be performed by a custom made computer-generated table. To conceal allocation, opaque envelopes will be assigned to the specific experimental site and will be opened during surgery Preoperative and 3- 6- 12-months postoperative intraoral standardized radiographs will be taken by the paralleling technique using an individual film-holder device consisting of a bite block rigidly connected to an acrylic dental splint to achieve identical film placement at each evaluation. Pre- and postoperative radiographs will be evaluated by two experienced clinicians who will be masked with respect to the provenience of the radiographs and the clinical measurements. The positions of alveolar crest level and of the bottom of the defect distance and will be marked by a pencil on the radiographs and bottom of the defect will be measured by a millimeter grid. Linear distances between the most coronal interproximal alveolar crest level and the bottom of the defect will be obtained by counting the walls
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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CH
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Chieti, CH, Itália, 66100
- G. D'Annunzio University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- a full-mouth plaque score (FMPS) 25 and a full-mouth bleeding score (FMBS) 26 < 20% at the time of surgery
- to have at least 20 teeth,; at least 1 tooth exhibiting vertical bone loss detected by radiographic examination (alveolar crest level (ACL) - bottom of the defect (BD) distance - -Bone defect depth (BDD) ≥ 4 mm and a probing pocket depth (PPD) ≥ 5mm when evaluated 12 weeks after phase I non- surgical therapy [ scaling and root planing ( SRP)]
Exclusion Criteria:
- no systemic diseases
- no medications affecting periodontal status during the previous 6 months
- not pregnant or lactating; non-smoker
- no periodontal therapy in the 2 previous years, no inadequate endodontic treatment, no dental mobility
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: Pacientes tratados com PRF
A cirurgia periodontal com fibrina rica em plaquetas é realizada, após anestesia local, os SPPFs mucoperiosteais serão aumentados.
O material BG corticoesponjoso autógeno será coletado com raspadores ósseos, a membrana PRF cortada em pequenos pedaços e misturada com o ABG será colocada dentro dos IBDs até que sejam completamente preenchidos.
Em seguida, as outras duas membranas PRF em cada paciente serão adaptadas sobre o defeito enxertado. Por fim, serão realizadas colchões horizontais e suturas interrompidas.
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Os pacientes serão tratados por retalhos cirúrgicos periodontais com adição de PRF + enxerto ósseo
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Comparador Ativo: GTR treated patients
Periodontal surgery with MEMBRANE is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised.
Autogenous corticocancellous BG material will be collected using bone scrapers ; then, ABG will be applied alternatively with MEMBRANE into the IBD according to the "sandwich" technique until the IBD will be completely filled.
Finally the flap will be repositioned and sutures completed by interrupted sutures.
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Patients will be treated by periodontal surgical flaps with the addition of Membrane+ bone graft
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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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Periodontal attachment gain
Prazo: 6 months
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Change of the distance between the cementum-enamel junction and the depth of the probable site
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6 months
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 062019
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