Clinical Evaluation of Postoperative Healing After Conventional And Laser Assisted Frenectomy Operations
9 de junho de 2018 atualizado por: Marmara University
The aim of this randomized controlled parallel-designed study was to evaluate clinical healing and patient comfort after conventional and diode laser assisted frenectomy operations in case of high papillary frenulum attachment.
Forty-eight patients with high papillary frenulum attachments were included in the study.
Patients were randomly divided into three groups; conventional frenectomy operation (Group C), frenectomy operation using diode laser (Group L) and diode laser asissted frenectomy with horizontal incision on the periosteum (Group L+P).
Postoperative pain, difficulty in speaking and eating scores were assessed postoperative 3 hours and 1, 7, 14, 21 and 45 days using Visual Analogue Scale (VAS).
Evaluation of epithelialization of the wound surface was carried out via hydrogen peroxide to the surface using a dental injector at postoperative 7, 14, 21 and 45 days.
Plaque index, gingival index, bleeding on probing and probing depth were assessed at baseline and postoperative 7, 14, 21 and 45 days.
All data were compared between groups and within each group.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
48
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
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Systemically healthy, nonsmoker, aged between 18 and 65, high papillary frenulum attachment diagnosed according to Mirko et al (Mirko et al, 1974), not received any periodontal treatment within the last 3 months, presence of at least central, lateral incisors and canines at the upper jaw, and consent to participate in the study.
Exclusion Criteria:
- Any systemic disease that might interfere with the prognosis of periodontal disease (i.e., diabetes mellitus, HIV infection), smoking, antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months that might affect the outcome of the study, any physical limitations or restrictions that might preclude normal oral hygiene procedures.
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Conventional Frenectomy
For the conventional surgery, after application of local infiltration anesthesia of articaine HCL associated with epinephrine 1:100,000, the frenulum was grasped with a straight haemostat inserted into the depth of the vestibule; the tissue adjacent to the upper and lower surfaces of the haemostat was incised with a no.15 scalpel.
After the diamond shaped resected portion of the frenulum was removed with the haemostat, muscle dilatations were excised on the submucosa of the lateral walls of the cavity.
Horizontal incision was made on the periosteum with the help of a scalpel following the procedure.
At the end of the operation, the wound was closed with absorbable sutures (4-0, Pegelak®, Doğsan Turkey).
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Frenectomy operation performed by surgical blades with suturing.
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Experimental: Diode Laser Frenectomy
For the laser frenectomy, a diode laser device (λ = 810 nm, W: 4, GIGA Cheese II, China) was used to perform the procedure.
The procedure was performed under local infiltration anesthesia with articaine HCL associated with epinephrine 1:100,000.
The frenlum was held by a haemostat inserted into the depth of the vestibule while laser energy was applied to the upper and lower parts of the frenulum adjacent to the haemostat via a fibre tip (400 µm diameter, plain-ended, optical fibre).
The laser was carefully applied to the tissue and care was taken to avoid local necrosis of the periosteum or any bone structure.Following the bleeding control, the wound site was left to secondary healing.
No sutures were necessary after procedure.
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Diode Laser assisted frenectomy operation.
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Experimental: Laser Frenectomy with Incision
For the laser frenectomy, a diode laser device (λ = 810 nm, W: 4, GIGA Cheese II, China) was used to perform the procedure.
The procedure was performed under local infiltration anesthesia with articaine HCL associated with epinephrine 1:100,000.
The frenulum was held by a haemostat inserted into the depth of the vestibule while laser energy was applied to the upper and lower parts of the frenulum adjacent to the haemostat via a fibre tip (400 µm diameter, plain-ended, optical fibre).
The laser was carefully applied to the tissue and care was taken to avoid local necrosis of the periosteum.
Horizontal incision was made on the periosteum with the help of a scalpel, additionally.
No sutures were necessary after procedure.
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Diode Laser assisted frenectomy operation.
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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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Postoperative Pain Change
Prazo: Postoperative pain, difficulty during speaking and eating scores were assessed on postoperative 3 hours and 1, 7, 14, 21 and 45 days.
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Postoperative pain during eating and speaking will be evaluate via visual analog scale (VAS).Visual Analogue Scale (VAS) was used to evaluate pain, discomfort during speaking and chewing.
VAS consisted of a horizontal line with a range of numbers from '0' to '10' of which '0' means 'no pain' and '10' means unbearable pain.
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Postoperative pain, difficulty during speaking and eating scores were assessed on postoperative 3 hours and 1, 7, 14, 21 and 45 days.
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Colaboradores e Investigadores
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Patrocinador
Datas de registro do estudo
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Datas Principais do Estudo
Início do estudo (Real)
1 de setembro de 2016
Conclusão Primária (Real)
1 de outubro de 2017
Conclusão do estudo (Real)
1 de outubro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
31 de março de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de junho de 2018
Primeira postagem (Real)
12 de junho de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de junho de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de junho de 2018
Última verificação
1 de junho de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Cetinkaya et al.
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