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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

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

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Locais de estudo

      • Cairo Governorate, Egito, 1123
        • Al Azhar Universty

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:

  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.

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

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Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
perforated membrane group
perforated membrane group (G1- 15 sites)
perforated membrane that could give a chance for posetive contributionn of periosteal and gingival mesenchymal stem cells in periodontal regeneration
Outros nomes:
  • collagen membranes
occlusive membrane group
occlusive collagen membrane that are tradetionally used in guided tissue regeneration , control occlusive group (G2-15 sites)
tradetional occlusive collagen membrane
Outros nomes:
  • guided tissue membranes

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
gingival cervicular fluid BMP-2 level
Prazo: 30 days
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.
30 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
intrabony components (defect bony filling)
Prazo: 9 months
Clinical and radiographic measurements (pocket depth, attachement level, gingival index , plaque index, intrabony level) were reassessed at 3, 6, and 9 months after surgery.
9 months

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

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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

Outros números de identificação do estudo

  • ahmedgamal

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