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Not yet recruitingNCT07675330OXY - MTAUpdated Jun 30, 2026

Oxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars

An interventional study of Oxymetazoline 0.05% nasal solution and Sodium Hypochlorite Solution in Pulp Disease, Dental, Pulp Therapy in Primary Molars and Pulpitis - Reversible, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
4 Years to 8 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Pulp Disease, Dental
  • Pulp Therapy in Primary Molars
  • Pulpitis - Reversible
  • Pulp Inflammation
  • Vital Pulp Therapies
  • Carious Exposure of Pulp
  • Primary Molar Tooth
  • Primary Molar Pulpotomy

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Keywords

  • Pulp therapy in primary molars
  • pulpotomy
  • MTA pulpotomy for primary molars
  • Sodium hypochlorite
  • Oxymetazoline
  • Hemostatic agents
  • NaOCl
  • Oxy
  • Oxymetazoline nasal spray
03

In context

Dental Pulp Diseases

130 studies on the registry are indexed under Dental Pulp Diseases; 37 are open to participants now.

This study's planned enrollment of 50 is close to the median of 52 across 108 interventional studies indexed under Dental Pulp Diseases.

Browse Dental Pulp Diseases studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

    • Patients:

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

        • Teeth:

      <!-- -->

      1. Previously accessed molars.
      2. Mobile primary molars.
      3. Presence of sinus tract or pain on percussion.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    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

    Other: Sodium Hypochlorite Solution

  • 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.

    Other: Oxymetazoline 0.05% nasal solution

Interventions

  • OtherOxymetazoline 0.05% nasal solution

    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.

    Also known as: Normifrin, Oxymet, OXY

  • OtherSodium Hypochlorite Solution

    Compression of a sterile cotton pellet soaked in 5% NaOCl over the pulpal stumps for 5 min

    Also known as: NaOCl

06

What researchers measure

Primary outcomes

  1. Clinical Success.

    •Spontaneous pain: will be evaluated by asking the patient and/or guardian. Unit of measurement: Binary.

    Time frame: Clinical evaluation will be performed at 1,3 &6 months postoperatively

  2. clinical success

    Pain to percussion: will be tested through percussion test (using the back of the dental mirror). Unit of measurement: Binary

    Time frame: Clinical evaluation will be performed at 1,3& 6 months postoperatively.

  3. Clinical success:

    • Sinus or fistula: will be evaluated through visual examination. Unit of measurement: Binary (yes or No)

    Time frame: Clinical evaluation will be performed at 1,3&6 months postoperatively.

  4. Clinical success

    Pathologic mobility: will be evaluated by mobility test (pressure using the ends of two dental mirrors.) Unit of measurement: Binary (yes or No)

    Time frame: Clinical evaluation will be performed at 1,3&6 months postoperatively.

Secondary outcomes

  1. Radiographic success.

    * Internal and external root resorption: will be evaluated by intraoral digital periapical X-ray. * Unit of measurement: Binary (yes or No).

    Time frame: Radiographic evaluation will be performed at 3 & 6 months postoperatively.

  2. Radiographic success

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

    Time frame: Radiographic evaluation will be performed at 3 & 6 months postoperatively.

  3. Radiographic succces

    Widening of PDL: will be evaluated by intraoral digital periapical X-ray. Binary outcome

    Time frame: Radiographic evaluation will be performed at 3 and 6 months postoperatively.

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 41597036 ↗
  • 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. PubMed 41369231 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07675330
Lead sponsor
Cairo University
Responsible party
Mariam Medhat (Pediatric dentistry resident, Cairo University) — Principal investigator
First posted
Jun 30, 2026
Start date
Aug 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 30, 2026

Study contacts

Mariam Medhat, Master's Degree candidate
Contact
mariam.abdelsameea@dentistry.cu.edu.eg
01011914614 ext. +2

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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