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- Ensaio Clínico NCT01860495
Gingival Crevicular Fluid Bone Morphogenetic Protein - 2 Release Profile Following the Use of Perforated Membrane (MPM)
21 de maio de 2013 atualizado por: Ahmed Y Gamal, Al-Azhar University
Gingival Crevicular Fluid Bone Morphogenetic Protein - 2 Release Profile Following the Use of Modified Perforated Membrane Barriers in Localized Intrabony Defects (An in Vivo Study)
One of the most important elements suggested to be provided through membrane perforations to augment regeneration are cell released growth factors from the overlying periosteal and gingival cells.
A direct correlation could exist between the number of such cells and their available released growth factors.
To test this assumption, this study was designed to evaluate levels of bone morphogenetic protein-2 in gingival crevicular fluid (GCF) during the early stages of healing for sites treated by MPM compared to that of the occlusive barrier membranes.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The subjects were recruited consecutively from the list of patients seeking care for periodontal problems at the Department of Periodontology of the Faculty of Dental Medicine, Al Azhar University, Cairo, Egypt, between March 2012 to December 2012.
The criteria implemented for patient inclusion were: 1) no systemic diseases which could influence the outcome of the therapy; 2) good compliance with the plaque control instructions following initial therapy; 3) teeth involved were all vital with score 0 mobility ; 4) each subject contributed matched pairs of two or three walled intrabony interproximal defects in premolar or molar teeth 5) the selected 2- or 3-wall intrabony defect depth ranged from 3-5 mm as detected in diagnostic periapical radiographs; 6) selected pocket depth (PD) ≥ 6 mm and clinical attachment level (CAL) ≥ 5 mm at the site of endosseous defect four weeks following initial cause-related therapy 7) endosseous radiographic defect angle ≤55 and ≥15 8) availability for the follow-up and maintenance program; 9) absence of periodontal treatment for the previous year; 10) absence of systemic medication or antibiotic treatment for the previous 6 months; 11) absence of a smoking habit and 12) absence of occlusal interferences.
Pregnant females were excluded from participating in the study.
Patients were also excluded from the study if they presented with opened interproximal contact, or inadequate compliance with the oral hygiene maintenance schedule.
The experimental protocol was approved by the Ethical Committee of El Azhar University (OMD - 45 - 2012, clinical trial registration number: Al Azhar University 22-31).
Research procedures were explained to all patients and they agreed to participate in the study and signed the appropriate informed consent form of Al Azhar University.
Tipo de estudo
Observacional
Inscrição (Real)
15
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Cairo Governorate, Egito, 1123
- Al Azhar Universty
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
31 anos a 51 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
Fifteen non-smoking patients (8 males and 7 females) who were 31 to 51 years of age at the time of baseline examination (mean age 33.8 ± 6.1) with severe chronic periodontitis (Armitage 1999) participated in this prospective, randomized and blinded clinical trial.
The subjects were recruited consecutively from the list of patients seeking care for periodontal problems at the Department of Periodontology of the Faculty of Dental Medicine, Al Azhar University, Cairo, Egypt, between March 2012 to December 2012.
The experimental protocol was approved by the Ethical Committee of El Azhar University (OMD - 45 - 2012).
Research procedures were explained to all patients and they agreed to participate in the study and signed the appropriate informed consent form of Al Azhar University.
Descrição
Inclusion Criteria:
- no systemic diseases which could influence the outcome of the therapy;
- good compliance with the plaque control instructions following initial therapy;
- teeth involved were all vital with score 0 mobility ;
- each subject contributed matched pairs of two or three walled intrabony interproximal defects in premolar or molar teeth
- the selected 2- or 3-wall intrabony defect depth ranged from 3-5 mm as detected in diagnostic periapical radiographs;
- selected pocket depth (PD) ≥ 6 mm and clinical attachment level (CAL) ≥ 5 mm at the site of endosseous defect four weeks following initial cause-related therapy
- endosseous radiographic defect angle ≤55 and ≥15
- availability for the follow-up and maintenance program;
- absence of periodontal treatment for the previous year;
- absence of systemic medication or antibiotic treatment for the previous 6 months;
- absence of a smoking habit and
- absence of occlusal interferences.
Exclusion Criteria:
- Pregnant females were excluded from participating in the study.
- Patients were also excluded from the study if they presented with opened interproximal contact, or inadequate compliance with the oral hygiene maintenance schedule.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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perforated membrane group
perforated membrane group (G1- 15 sites)
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perforated membrane that could give a chance for posetive contributionn of periosteal and gingival mesenchymal stem cells in periodontal regeneration
Outros nomes:
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occlusive membrane group
occlusive collagen membrane that are tradetionally used in guided tissue regeneration , control occlusive group (G2-15 sites)
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tradetional occlusive collagen membrane
Outros nomes:
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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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gingival cervicular fluid BMP-2 level
Prazo: 30 days
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Using capillary tube (5 µl), gingival cervicular fluid (GCF) samples were collected (Sueda et al, 1969) by a single examiner (MA) who was masked to the attribution of the sites to MPM or OM.
Following the isolation and drying of the selected site with cotton rolls, a fisher brand disposable micropipettes €, placed intrasulculary at the mesiofacial line angle of the selected site to a maximum depth of 2 mm below the gingival margin.
Micropipettes were left in place until 5ul of fluid was collected.
Gingival cervicular fluid (GCF) samples were collected one day, 3, 7, 14, 21, and 30 days after therapy and diluted in saline solution (50 µl) for bone morphogenetic protein-2 level evaluation.
Samples were labeled, carried in a dark container and kept at -80 C until used.
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30 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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intrabony components (defect bony filling)
Prazo: 9 months
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Clinical and radiographic measurements (pocket depth, attachement level, gingival index , plaque index, intrabony level) were reassessed at 3, 6, and 9 months after surgery.
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9 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Ahmed Y Gamal, PhD, Al Azhar universty, faculty of dentistry, cairo, egypt
- Diretor de estudo: Mohamed M Aziz, BCH, al azhar universty, cairo, egypt
- Diretor de estudo: Mohamed M Helmy, MSD, Al Azhar Universty
- Cadeira de estudo: Vencint J Iacono, PhD, Stony Brook Uiversty
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de março de 2012
Conclusão Primária (Real)
1 de maio de 2012
Conclusão do estudo (Real)
1 de dezembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
19 de maio de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de maio de 2013
Primeira postagem (Estimativa)
22 de maio de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
22 de maio de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de maio de 2013
Última verificação
1 de maio de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ahmedgamal
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