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Effect of a Maintenance Protocol After Surgical Treatment of Peri-implantitis

5 de outubro de 2022 atualizado por: Universidad Complutense de Madrid

Effect of a Maintenance Protocol Based on the Surgical Treatment of Peri-implantitis and Implant Surface Decontamination With Glycine Powder Air-polishing

This study was designed as a 12-month, two arms, randomized clinical trial to evaluate the efficacy of a supportive treatment protocol (SPIT). Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups. After ultrasonic debridement, the affected implant surfaces of the test group were treated with glycine powder air-polishing, while implants in the control group a rubber cup and polishing paste was used. Maintenance visits were carried every 3 months and clinical, radiological, microbiological and biochemical variables were registered at baseline (6 months after surgery) and after a follow-up period of 12 months (18 months after surgery).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Study design:

This study was designed as a 12-month, two arms, RCT to evaluate the efficacy of a SPIC protocol. Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups. After ultrasonic debridement, the affected implant surfaces of the test group were treated with glycine powder air-polishing, while implants in the control group a rubber cup and polishing paste was used. Maintenance visits were carried every 3 months and clinical, radiological, microbiological and biochemical variables were registered at baseline (6 months after surgery) and after a follow-up period of 12 months (18 months after surgery).

Interventions:

At the 6-month evaluation after the surgery, the baseline data for the present study were obtained and patients were randomised using a computerized block randomization protocol to one of the following SPIC protocols. In the test group, implant surfaces were treated with glycine powder air-polishing after ultrasonic instrumentation; the specific nozzle was activated subgingivally and circumferentially around the implant for 1 minute. In the control group, implants were cleaned with a rubber cup and polishing paste after ultrasonic instrumentation. This SPIC visits were carried out at 6 (baseline visit), 9, 12, 15 and 18 months after surgery.

Tipo de estudo

Intervencional

Inscrição (Real)

30

Estágio

  • Não aplicável

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

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Presence of at least one implant with peri-implantitis, defined as: radiographic evidence of bone loss >2 mm, inflammation of the peri-implant mucosa as defined by positive BoP and/or suppuration, and at least one site with PD ≥ 5 mm.
  • Based on the radiographic examination, the affected implant should not have a vertical peri-implant defect. Positive selection was based on the presence of pe-ri-implant lesions wider than 4 mm, with an angle greater than 35 º.
  • In patients with a history of periodontitis, periodontal therapy should have been provided at least 6 months prior to the initiation of the study.

Exclusion Criteria:

  • Presence of relevant medical conditions and/or systemic medications that would contraindicate the surgical procedure or modify the tissue response after therapy.
  • Patients requiring antibiotic prophylaxis.
  • Heavy smokers (> 10 cigarettes/day).
  • Pregnant or lactating women

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

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Glycine - Test
Polishing treatment with glycine powder air-polishing after ultrasonic plaque debridement.
Procedimento: Glycine air powder
Every 3 months, ultrasonic instrumentation was carried out with an specific implant tip coated with Polyether Ether Ketone (PEEK), activated subgingivally and circumferentially around the implant. Then, the implants were treated with glycine powder air-polishing.
Comparador Ativo: Rubber cup - Control
Polishing treatment with a rubber cup and polishing paste after ultrasonic debridement
Procedimento: Rubber cup polishing
Every 3 months, ultrasonic instrumentation was carried out with an specific implant tip coated with Polyether Ether Ketone (PEEK), activated subgingivally and circumferentially around the implant. Then, the implants were treated with rubber cup and a polishing paste.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Probing Pocket Depth
Prazo: Baseline, 6 and 18 months after the surgical procedure
Changes in Probing Pocket Depth measured in milimeters with a manual periodontal probe
Baseline, 6 and 18 months after the surgical procedure

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Distance of Gingival Recession
Prazo: Baseline, 6 and 18 months after the surgical procedure
Recession distance of the mucosal margin relative to the restoration margin (REC) at the implant (6 sites/implant) measured in milimeters with a manual periodontal probe
Baseline, 6 and 18 months after the surgical procedure
Bleeding on Probing index
Prazo: Baseline, 6 and 18 months after the surgical procedure
Rate of Presence / absence Bleeding on Probing at the implant (6 sites/implant)
Baseline, 6 and 18 months after the surgical procedure
Plaque Index
Prazo: Baseline, 6 and 18 months after the surgical procedure
Rate of Presence / absence of Plaque at the implant (6 sites/implant)
Baseline, 6 and 18 months after the surgical procedure
Suppuration Index
Prazo: Baseline, 6 and 18 months after the surgical procedure
Rate of Presence / absence of suppuration at the implant (6 sites/implant)
Baseline, 6 and 18 months after the surgical procedure
Radiographic bone loss distance measured from the prosthetic connection platform to the bottom of the intraosseous defect
Prazo: Baseline, 6 and 18 months after the surgical procedure
Intraoral standardised radiographs of the site of interest measured in digital intraoral radiographs using an image-processing software
Baseline, 6 and 18 months after the surgical procedure
Concentration of the selected cytokines measured in pg/ml (IL1B; Il-6; IL-8; Tumoral Necrosis Factor Alpha)
Prazo: Baseline, 6 and 18 months after the surgical procedure
Samples taken from the gingival crevicular fluid (GCF) were taken from each included implant from the deepest PD site with positive BoP, at baseline and at the final evaluation, always prior to microbiological sampling. Samples were taken using the filter paper technique. After isolation of the area with cotton rolls and gentle cleaning with air and a gauze to remove supragingival biofilm deposits and potential saliva contamination, a paper strip of standard length and height was inserted into the peri-implant pocket, until mild resistance was felt and left in place for 30 seconds. The soaked volume of GCF was measured using the Periotron 8000® device. Subsequently, the paper strips were inserted in micro-centrifuge plastic tubes and immediately stored at -80°C until further processing. Analyses were carried out using a Luminex System (Luminex® 200, Luminex Corporation, Austin, TX, USA) to determine volume of the following biomarkers: IL-1β, IL-6, IL-8 and TNF-α.
Baseline, 6 and 18 months after the surgical procedure
Presence of putative periodontal pathogens
Prazo: Baseline, 6 and 18 months after the surgical procedure
Sample from the deepest site in the evaluated implant using two consecutive sterile paper-points kept in place for 10 seconds and then transferred into a screw-capped vial, containing 1.5 mL of reduced transport fluid (RTF). Samples were transferred to the microbiological laboratory within 2 hours and homogenized by vortexing for 30 seconds and serially diluted in phosphate buffer saline (PBS). Then, 0.1 mL of each dilution was plated manually on the specific medium Dentaid-1, for the detection of Aggregatibacter actinomycetemcomitans, and incubated for 3 days in air with 5% CO2 at 37ºC. Samples were also plated into a non-selective blood agar plate, supplemented with haemine (5 mg/l), menadione (1 mg/l) and 5% sterile horse blood, with 7-14 days of anaerobic incubation.
Baseline, 6 and 18 months after the surgical procedure
Frequency of detection of putative periodontal pathogens
Prazo: Baseline, 6 and 18 months after the surgical procedure
Sample from the deepest site in the evaluated implant using two consecutive sterile paper-points kept in place for 10 seconds and then transferred into a screw-capped vial, containing 1.5 mL of reduced transport fluid (RTF). Samples were transferred to the microbiological laboratory within 2 hours and homogenized by vortexing for 30 seconds and serially diluted in phosphate buffer saline (PBS). Then, 0.1 mL of each dilution was plated manually on the specific medium Dentaid-1, for the detection of Aggregatibacter actinomycetemcomitans, and incubated for 3 days in air with 5% CO2 at 37ºC. Samples were also plated into a non-selective blood agar plate, supplemented with haemine (5 mg/l), menadione (1 mg/l) and 5% sterile horse blood, with 7-14 days of anaerobic incubation.
Baseline, 6 and 18 months after the surgical procedure
Proportions of putative periodontal pathogens
Prazo: Baseline, 6 and 18 months after the surgical procedure
Sample from the deepest site in the evaluated implant using two consecutive sterile paper-points kept in place for 10 seconds and then transferred into a screw-capped vial, containing 1.5 mL of reduced transport fluid (RTF). Samples were transferred to the microbiological laboratory within 2 hours and homogenized by vortexing for 30 seconds and serially diluted in phosphate buffer saline (PBS). Then, 0.1 mL of each dilution was plated manually on the specific medium Dentaid-1, for the detection of Aggregatibacter actinomycetemcomitans, and incubated for 3 days in air with 5% CO2 at 37ºC. Samples were also plated into a non-selective blood agar plate, supplemented with haemine (5 mg/l), menadione (1 mg/l) and 5% sterile horse blood, with 7-14 days of anaerobic incubation.
Baseline, 6 and 18 months after the surgical procedure
Counts of putative periodontal pathogens
Prazo: Baseline, 6 and 18 months after the surgical procedure
Sample from the deepest site in the evaluated implant using two consecutive sterile paper-points kept in place for 10 seconds and then transferred into a screw-capped vial, containing 1.5 mL of reduced transport fluid (RTF). Samples were transferred to the microbiological laboratory within 2 hours and homogenized by vortexing for 30 seconds and serially diluted in phosphate buffer saline (PBS). Then, 0.1 mL of each dilution was plated manually on the specific medium Dentaid-1, for the detection of Aggregatibacter actinomycetemcomitans, and incubated for 3 days in air with 5% CO2 at 37ºC. Samples were also plated into a non-selective blood agar plate, supplemented with haemine (5 mg/l), menadione (1 mg/l) and 5% sterile horse blood, with 7-14 days of anaerobic incubation.
Baseline, 6 and 18 months after the surgical procedure

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Universidad Complutense de Madrid

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 (Real)

1 de janeiro de 2013

Conclusão Primária (Real)

1 de agosto de 2021

Conclusão do estudo (Real)

1 de agosto de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

26 de setembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de outubro de 2022

Primeira postagem (Real)

10 de outubro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de outubro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de outubro de 2022

Última verificação

1 de setembro de 2022

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • EMS/MTO

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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