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- Essai clinique NCT07675330
Oxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars (OXY - MTA)
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mariam Medhat, Master's Degree candidate
- Numéro de téléphone: +2 01011914614
- E-mail: mariam.abdelsameea@dentistry.cu.edu.eg
Lieux d'étude
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Cairo, Egypte
- Faculty of dentistry, Cairo University.
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Contact:
- Cairo University
- Numéro de téléphone: 0223634965
- E-mail: dentmail@dentistry.cu.edu.eg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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.
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Exclusion Criteria:
• Patients:
- Uncooperative children.
- Medically compromised children.
Patients whose parents refuse to participate or refuse to sign the informed consent.
- Teeth:
- Previously accessed molars.
- Mobile primary molars.
- Presence of sinus tract or pain on percussion.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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
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Compression of a sterile cotton pellet soaked in 5% NaOCl over the pulpal stumps for 5 min
Autres noms:
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Expérimental: 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.
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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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinical Success.
Délai: Clinical evaluation will be performed at 1,3 &6 months postoperatively
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•Spontaneous pain: will be evaluated by asking the patient and/or guardian.
Unit of measurement: Binary.
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Clinical evaluation will be performed at 1,3 &6 months postoperatively
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clinical success
Délai: Clinical evaluation will be performed at 1,3& 6 months postoperatively.
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Pain to percussion: will be tested through percussion test (using the back of the dental mirror).
Unit of measurement: Binary
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Clinical evaluation will be performed at 1,3& 6 months postoperatively.
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Clinical success:
Délai: Clinical evaluation will be performed at 1,3&6 months postoperatively.
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• Sinus or fistula: will be evaluated through visual examination.
Unit of measurement: Binary (yes or No)
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Clinical evaluation will be performed at 1,3&6 months postoperatively.
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Clinical success
Délai: Clinical evaluation will be performed at 1,3&6 months postoperatively.
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Pathologic mobility: will be evaluated by mobility test (pressure using the ends of two dental mirrors.)
Unit of measurement: Binary (yes or No)
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Clinical evaluation will be performed at 1,3&6 months postoperatively.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Radiographic success.
Délai: Radiographic evaluation will be performed at 3 & 6 months postoperatively.
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Radiographic evaluation will be performed at 3 & 6 months postoperatively.
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Radiographic success
Délai: Radiographic evaluation will be performed at 3 & 6 months postoperatively.
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Furcal abscess: will be evaluated by intraoral digital periapical X-ray. • Binary outcome |
Radiographic evaluation will be performed at 3 & 6 months postoperatively.
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Radiographic succces
Délai: Radiographic evaluation will be performed at 3 and 6 months postoperatively.
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Widening of PDL: will be evaluated by intraoral digital periapical X-ray.
Binary outcome
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Radiographic evaluation will be performed at 3 and 6 months postoperatively.
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Jones RS, Lee H, Jia J, Sarvas EW. An Oxymetazoline-Based Hemostatic Solution Used with MTA for Pulpal Therapy: A Retrospective Study. Children (Basel). 2025 Dec 24;13(1):28. doi: 10.3390/children13010028.
- Jones RS, Garcia R, Mutreja I, Kumar D. Tissue Biocompatibility and Antimicrobial Properties of Sympathomimetic Nasal Solutions for Potential Use in Dental Pulpal Management. Clin Exp Dent Res. 2025 Dec;11(6):e70259. doi: 10.1002/cre2.70259.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies stomatognathiques
- Maladies dentaires
- Maladies de la pulpe dentaire
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Azoles
- Imidazoles
- Produits chimiques inorganiques
- Composés de chlore
- Oxydes
- Composés d'oxygène
- Acide hypochlouleux
- Composés de sodium
- Hypochlorite de sodium
- Oxymétazoline
Autres numéros d'identification d'étude
- CairoUni-PEDO-2026-06-16-Int-1
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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