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"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction

4 de fevereiro de 2021 atualizado por: Postgraduate Institute of Dental Sciences Rohtak

"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction: A Split Mouth Randomized Clinical Trial"

Acceleration of orthodontic tooth movement persuades tremendous rise in the interest of adolescents and aduts, as it not only shortens the treatment duration but also lessens the incidence of white spot lesions, root resorption, periodontal and other soft tissue problems. Minimal invasive techniques i.e.both piezocision and micro-osteoperforations had promising results in accelerating tooth movement. Therefore current study will provide evidence for better minimal invasive technique in terms of reducing treatment time and patient comfort.

Visão geral do estudo

Status

Desconhecido

Condições

Angle Class II, Division 1 Malocclusion

Intervenção / Tratamento

Descrição detalhada

Patients with Angle's Class II division 1 malocclusion meeting selection criteria and are indicated for maxillary first premolar extraction, patients will be referred for extraction of the maxillary first premolars , treatment will be initiated by bonding preadjusted MBT 0.022" slot straight wire appliance(Patient will be instructed to report immediately in case of breakage of appliance), after that, leveling and alignment will be done in all subjects, after insertion of 0.019"× 0.025" stainless steel arch wire, alginate impression and periapical radiograph of canine and first molar region will be taken(Before the initiation of canine retraction), randomisation and allocation of two sides of maxillary arch i.e. right and left will be done and active interventions(piezocision and micro-osteoperforations) for each side will be done, immediately maxillary canine retraction will be started with mini-implant and closed NiTi coil spring, patient will be asked to fill pain and discomfort assessment card immediately after initiation of canine retraction., subsequent impressions records will be taken at 4th, 8th, 12th and 16th weeks for measuring rate of maxillary canine retraction, data collection and interpretation of results, further pain assessment cards will be filled after 24 hours, on 7th day and 28th day

Tipo de estudo

Intervencional

Inscrição (Antecipado)

Estágio

Não aplicável

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

Índia
- Haryana
  - Rohtak, Haryana, Índia, 124001
    - Recrutamento
    - Post Graduate Institute of Dental Sciences

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

16 anos a 25 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

Patients with age between 16-25 years
Patients with Angle's class II division 1 malocclusion requiring bilateral extraction of maxillary first premolars.
Overjet of ≤ 10mm
No debilitating systemic disease.
No radiographic evidence of bone loss.
No history of periodontal disease/ therapy.
No smoking habit.
Probing depth of not more than 3mm in all teeth.

Exclusion Criteria:

Presence of any signs and symptoms of gingival and periodontal diseases.
Overjet more than 10mm.
Long-term drug history.
Systemic diseases.
Evidence of bone loss.
Smoking habit.

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: Dobro

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço	Intervenção / Tratamento
Experimental: Piezocision on Experimental Side A Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome to accelerate maxillary canine retraction	Procedimento: Piezocision Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome. These piezocisions will be performed on the buccal cortical bone only, 2-3mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and gingival overlying will be incised first with blade number 15 in a Bard Parker handle . The exact location of incision will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added and then 5mm incision is given in gingiva and overlying mucoperiosteum in a vertical line apically to expose the underlying bone.
Experimental: Micro-osteoperforations on Experimental side B Three MOPs with the help of mini-implant screw driver,mesial and distal to canine(in a vertical line) with the help of minisrew implant driver to accelrate maxillary canine retraction	Procedimento: Micro-osteoperforations Three MOPs mesial and three MOPs distal to canine(in a vertical line) with the help of minisrew implant driver (fig.2). These MOPs will be performed on the buccal cortical bone only, 2-3 mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and no flap will be raised. The exact location of first MOP will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added. The location of second MOP at 5mm apically in a vertical line and third MOP at 5 mm apically to second MOP

Grupo de Participantes / Braço

Intervenção / Tratamento

Experimental: Piezocision on Experimental Side A

Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome to accelerate maxillary canine retraction

Procedimento: Piezocision

Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome. These piezocisions will be performed on the buccal cortical bone only, 2-3mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and gingival overlying will be incised first with blade number 15 in a Bard Parker handle . The exact location of incision will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added and then 5mm incision is given in gingiva and overlying mucoperiosteum in a vertical line apically to expose the underlying bone.

Experimental: Micro-osteoperforations on Experimental side B

Three MOPs with the help of mini-implant screw driver,mesial and distal to canine(in a vertical line) with the help of minisrew implant driver to accelrate maxillary canine retraction

Procedimento: Micro-osteoperforations

Three MOPs mesial and three MOPs distal to canine(in a vertical line) with the help of minisrew implant driver (fig.2). These MOPs will be performed on the buccal cortical bone only, 2-3 mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and no flap will be raised. The exact location of first MOP will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added. The location of second MOP at 5mm apically in a vertical line and third MOP at 5 mm apically to second MOP

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Measurement of rate of canine retraction Prazo: 4th week	Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction	4th week
Measurement of rate of canine retraction Prazo: 8th week	Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction	8th week
Measurement of rate of canine retraction Prazo: 12th week	Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction	12th week
Measurement of rate of canine retraction Prazo: 16th week	Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction	16th week

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Assessment of pain/discomfort level Prazo: at the beginning of canine retraction	The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).	at the beginning of canine retraction
Assessment of pain/discomfort level Prazo: 24 hours	The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).	24 hours
Assessment of pain/discomfort level Prazo: 7th day	The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).	7th day
Assessment of pain/discomfort level Prazo: 28th day	The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).	28th day

Colaboradores e Investigadores

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

Patrocinador

Postgraduate Institute of Dental Sciences Rohtak

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)

25 de dezembro de 2020

Conclusão Primária (Antecipado)

1 de setembro de 2021

Conclusão do estudo (Antecipado)

1 de dezembro de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

14 de dezembro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de fevereiro de 2021

Primeira postagem (Real)

8 de fevereiro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de fevereiro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de fevereiro de 2021

Última verificação

1 de fevereiro de 2021

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

Karan.mahendru

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction