Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Clinical and Biochemical Evaluation of Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
The aim of the present study is to evaluate and compare the clinical and biochemical outcomes of Ozoral® and High Cure® (chlorhexidine gel) as adjuncts to non-surgical periodontal therapy in smoker patients with Stage II Grade B periodontitis, using non-smoker patients with the same diagnosis as a comparative control group.
Visão geral do estudo
Status
Descrição detalhada
Periodontal diseases are disease processes involving the periodontium, a term used to describe the supportive apparatus surrounding a tooth, which includes the gingival tissue, alveolar bone, cementum, and periodontal ligament.
Chlorhexidine (CHX) has been widely used in dentistry as an antiplaque and antimicrobial agent due to its broad-spectrum activity against Gram-positive and Gram-negative bacteria, fungi, and some viruses. The antimicrobial action of chlorhexidine is mainly attributed to its ability to alter bacterial cell membrane permeability, resulting in leakage of intracellular components.
Ozone (O₃) is a highly reactive oxidizing agent that has gained increasing attention in medical and dental applications because of its potent antimicrobial, anti-inflammatory, and wound-healing properties. Ozone exerts its antimicrobial effect through oxidative damage to microbial cell walls and intracellular components, leading to rapid microbial inactivation.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Sara A Agha, B.D.S
- Número de telefone: 00201025536848
- E-mail: Ahmedagha55aa@gmail.com
Locais de estudo
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Cairo, Egito, 12511
- Recrutamento
- October 6 University
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Subinvestigador:
- Osama S El-Shall, MD
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Contato:
- Sara A Agha, B.Sc
- Número de telefone: 00201025536848
- E-mail: Ahmedagha55aa@gmail.com
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Subinvestigador:
- Amany A Al-Araby, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Male and female patients aged 25-45 years
- Diagnosed with Stage II Grade B periodontitis
- Clinical attachment loss of 3-4 mm
- Radiographic bone loss confined to the coronal third of the root
- Either smokers or non-smokers
Exclusion Criteria:
- Systemic diseases affecting periodontal health
- Pregnancy or lactating female
- Periodontal therapy within the last 6 months
- Use of antibiotics or anti-inflammatory medication during the last
Plano de estudo
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: Group I (control - standard of care control)
Participants will receive conventional scaling and root planing only. |
Participants will receive conventional scaling and root planing only. |
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Experimental: Group II (experimental)
Participants will receive conventional scaling and root planing in addition to chlorhexidine gel application according to the manufacturer's instructions for subgingival delivery. |
Participants will receive conventional scaling and root planing in addition to chlorhexidine gel application according to the manufacturer's instructions for subgingival delivery. |
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Experimental: Group III (experimental)
Participants will receive conventional scaling and root planing in addition to ozone gel application according to the manufacturer's instructions for subgingival delivery. |
Participants will receive conventional scaling and root planing in addition to ozone gel application according to the manufacturer's instructions for subgingival delivery. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in gingival crevicular fluid tumor necrosis factor-alpha level
Prazo: 6 months after treatment
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Change from baseline in gingival crevicular fluid tumor necrosis factor-alpha (TNF-α) level will be measured using enzyme-linked immunosorbent assay (ELISA) at baseline, 15 days, and 6 months after treatment.. |
6 months after treatment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in gingival crevicular fluid Interleukin-1 level
Prazo: 6 months after treatment
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Change from baseline in gingival crevicular fluid Interleukin-1(IL-1) evel will be measured using enzyme-linked immunosorbent assay (ELISA) at baseline, 15 days, and 6 months after treatment.. |
6 months after treatment
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Change in Plaque Index
Prazo: 6 months after treatment
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Change from baseline in Plaque Index, scored from 0 (no plaque) to 3 (abundant plaque accumulation). Lower scores indicate better oral hygiene. Changes will be compared among the three treatment groups. |
6 months after treatment
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Change in Gingival Index
Prazo: 6 months after treatment
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Change from baseline in Gingival Index, scored from 0 (normal gingiva) to 3 (severe inflammation with a tendency toward spontaneous bleeding). Lower scores indicate less gingival inflammation. Changes will be compared among the three treatment groups. |
6 months after treatment
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Change in Periodontal Probing Depth
Prazo: 6 months after treatment
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Change from baseline in periodontal probing depth will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a periodontal probe. A reduction indicates improvement. Changes will be compared among the three treatment groups. |
6 months after treatment
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Change in Clinical Attachment Level
Prazo: 6 months after treatment
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Change from baseline in clinical attachment level will be measured in millimeters from the cementoenamel junction to the base of the periodontal pocket using a periodontal probe. A reduction in this distance indicates clinical attachment gain. Changes will be compared among the three treatment groups. |
6 months after treatment
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- (4) 27/4/2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Prazo de Compartilhamento de IPD
After the end of study for one year.
Critérios de acesso de compartilhamento IPD
The data will be available upon a reasonable request from the corresponding author.
Tipo de informação de suporte de compartilhamento de IPD
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