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Oxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars (OXY - MTA)

26 de junho de 2026 atualizado por: Mariam Medhat, Cairo University

Comparative Evaluation of Clinical and Radiographic Success of Oxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars in a Group of Egyptian Children: A Randomized Controlled Trial

This study aims to evaluate clinical and radiographic success of oxymetazoline versus sodium hypochlorite as hemostatic agents in MTA pulpotomy of primary molars.

Visão geral do estudo

Descrição detalhada

The rationale for pulpotomy procedure is based on the healing capacity of the remaining pulp tissue following surgical amputation of the affected or infected coronal pulp. After achieving hemostasis, the exposed pulp stumps are covered either with a pulp-capping agent that promotes healing or with an agent that fixes the underlying tissue. MTA has been established as the gold standard medicament for pulpotomy owing to its several desirable properties such as biocompatibility, bioactivity, hydrophilicity, radiopacity, sealing ability and low solubility.

Besides the type of the pulp dressing material, one of the crucial parameters influencing the success of the pulpotomy procedure is the ability to control bleeding from the amputated pulp tissue. Selection of a hemostatic agent during pulpotomy has been a subject of extensive research and debate with respect to its influence on clinical and radiographic outcomes. The hemostatic agent provides not only hemostasis but also a sterile environment which is essential for pulp healing. Failure to achieve proper hemostasis means that blood will be continuously oozing out resulting in dislodgment of the placed medicament which will form a thick fibro purulent membrane over the pulpal tissue creating a dead space paving way for secondary infection and subsequent failure of the procedure. Furthermore, blood clot formation after hemostasis is undesirable because the fibrin present in the clot can act as a chemoattractant for polymorphonuclear leukocytes leading to prolonged pulpal inflammation.

Sodium hypochlorite (NaOCl) is one of the most popular hemostatic agents. It has tissue dissolution capacity by interfering with the cytoplasmic membrane integrity leading to irreversible enzymatic inhibition, biosynthetic change in cell metabolism, and phospholipid destruction in lipid peroxidation. It also helps in the formation of dentinal bridge. NaOCl has unique properties of simultaneous disinfection of dentine-pulp interface and chemical amputation of necrotic cells and blood clot. This ensures direct contact between pulp tissue and the capping material facilitating wound healing. In spite of its favorable antibacterial and hemostatic properties, NaOCl is considered cytotoxic. A histological study demonstrated that irrigating the tooth with 5.25% NaOCl after access opening resulted in damage to pre-dentine and dissolution of up to 4-5 layers of odontoblasts in the pulp tissue, consequently increasing the risk of internal root resorption after exposure of calcified tissue.

Furthermore, NaOCl was found to be hazardous to dental pulp stem cells (DPSCs) and hence it may theoretically cause a disturbance in pulp healing and negatively influence the outcome of the pulpotomy procedure. Moreover, NaOCl is believed to cause damage to the surrounding tissues, and alter the properties of the remaining tooth structure as it is associated with a significant decrease in dentin elastic modulus and flexural strength. Unpleasant taste and odor could also be added to the list of drawbacks of NaOCl.

Dental pulp tissue is innervated mainly by the autonomic nervous system, and activation of α-1 receptors causes vasoconstriction. Oxymetazoline (OXY) is a highly effective α -1 receptors agonist and can initiate hemostasis by vasoconstricting the smooth muscles associated with arterioles and venules in pulp tissue.

Nasal sprays containing oxymetazoline (NS-OXY) are routinely used during otorhinolaryngology surgical procedures and by anesthesia teams to control nasal bleeding during intubation. OXY has a transient effect and is eventually systemically absorbed via blood circulation. As a selective α-1 receptors agonist, OXY has low activity on beta-adrenergic receptors that increase heart rate. This selectivity adds to the safety profile of NS-OXY in children and adults for use as a nasal decongestant and hemostatic agent in surgery.

In addition to providing effective hemostasis, NS-OXY products contain compounds that help eradicate oral bacteria that may contaminate the blood clot. NS-OXY contains benzalkonium chloride (BKC) and edetate disodium (EDTA), which are antibacterial compounds. BKC and EDTA are preservatives that increase the shelf life of the NS-OXY bottle and reduce bacterial contamination when NS-OXY is used intranasally and comes in contact with nasal bacteria. BKC, a cationic organic quaternary ammonium compound, exhibits broad antimicrobial activity and antimatrix metalloproteinase activity. Furthermore, it was found that BKC exerts a membrane disruption action against S. mutans and R. dentocariosa. EDTA improves the bacterial membrane disruption activity of BKC. Moreover, EDTA is highly biocompatible with dental pulp cells and has the potential to be bio-inductive towards mineralization through the release of transforming growth factor-β1 (TGF1β) from the dentin matrix. According to Jones et al 2026, OXY is biocompatible with dental human pulp stem cells and can be used as a hemostatic agent prior to the placement of MTA.

Tipo de estudo

Intervencional

Inscrição (Estimado)

50

Estágio

  • Não aplicável

Contactos e Locais

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Contato de estudo

Locais de estudo

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

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

• Patients: Egyptian children with carious mandibular primary molars aged 4-8 years.

• Teeth: Restorable mandibular primary molars with no clinical signs or symptoms of irreversible pulpitis.

• Pre-operative Radiograph: No radiographic signs of internal or external root resorption and no furcation or periapical radiolucencies.

-

Exclusion Criteria:

  • • Patients:

    1. Uncooperative children.
    2. Medically compromised children.
    3. Patients whose parents refuse to participate or refuse to sign the informed consent.

      • Teeth:
    1. Previously accessed molars.
    2. Mobile primary molars.
    3. Presence of sinus tract or pain on percussion.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

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

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Using sodium hypochlorite as hemostatic agent in MTA pulpotomy of primary molars
Compression of a sterile cotton pellet soaked in 5% NaOCl over the pulpal stumps for 5 minutes to achieve hemostasis after excavation of coronal pulp tissue
Compression of a sterile cotton pellet soaked in 5% NaOCl over the pulpal stumps for 5 min
Outros nomes:
  • NaOCl
Experimental: Using Oxymetazoline as hemostatic agent in MTA pulpotomy of primary molars.
Using 1 drop (~0.05 mL) of 0.05% OXY (Normifrin Nasal spray, MUP, Egypt, and generic equivalents) delivered through a micro- brush or a small cotton pellet placed over pulp stumps to achieve hemostasis after excavation of coronal pulp tissue.
Using 1 drop (~0.05 mL) of 0.05% OXY (Normifrin Nasal spray, MUP, Egypt, and generic equivalents) delivered through a micro- brush or a small cotton pellet over pulp stumps to achieve hemostasis.
Outros nomes:
  • OXY
  • Normifrin
  • Oxymet

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Clinical Success.
Prazo: Clinical evaluation will be performed at 1,3 &6 months postoperatively
•Spontaneous pain: will be evaluated by asking the patient and/or guardian. Unit of measurement: Binary.
Clinical evaluation will be performed at 1,3 &6 months postoperatively
clinical success
Prazo: Clinical evaluation will be performed at 1,3& 6 months postoperatively.
Pain to percussion: will be tested through percussion test (using the back of the dental mirror). Unit of measurement: Binary
Clinical evaluation will be performed at 1,3& 6 months postoperatively.
Clinical success:
Prazo: Clinical evaluation will be performed at 1,3&6 months postoperatively.
• Sinus or fistula: will be evaluated through visual examination. Unit of measurement: Binary (yes or No)
Clinical evaluation will be performed at 1,3&6 months postoperatively.
Clinical success
Prazo: Clinical evaluation will be performed at 1,3&6 months postoperatively.
Pathologic mobility: will be evaluated by mobility test (pressure using the ends of two dental mirrors.) Unit of measurement: Binary (yes or No)
Clinical evaluation will be performed at 1,3&6 months postoperatively.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Radiographic success.
Prazo: Radiographic evaluation will be performed at 3 & 6 months postoperatively.
  • Internal and external root resorption: will be evaluated by intraoral digital periapical X-ray.
  • Unit of measurement: Binary (yes or No).
Radiographic evaluation will be performed at 3 & 6 months postoperatively.
Radiographic success
Prazo: Radiographic evaluation will be performed at 3 & 6 months postoperatively.

Furcal abscess: will be evaluated by intraoral digital periapical X-ray.

• Binary outcome

Radiographic evaluation will be performed at 3 & 6 months postoperatively.
Radiographic succces
Prazo: Radiographic evaluation will be performed at 3 and 6 months postoperatively.
Widening of PDL: will be evaluated by intraoral digital periapical X-ray. Binary outcome
Radiographic evaluation will be performed at 3 and 6 months postoperatively.

Colaboradores e Investigadores

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Patrocinador

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 (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

23 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de junho de 2026

Primeira postagem (Real)

30 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

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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

produto fabricado e exportado dos EUA

Não

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