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

26. juni 2026 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Andre navne:
  • NaOCl
Eksperimentel: 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.
Andre navne:
  • OXY
  • Normifrin
  • Oxymet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Success.
Tidsramme: 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
Tidsramme: 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:
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Radiographic success.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

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Publikationer og nyttige links

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2026

Sidst verificeret

1. juni 2026

Mere information

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