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Pulp Disease, DentalOXY - MTANCT07675330

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

A study testing Oxymetazoline 0.05% nasal solution and Sodium Hypochlorite Solution in people with Pulp Disease, Dental and Pulp Therapy in Primary Molars, run by Cairo University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 4 to 8 years
What is being tested?
Oxymetazoline 0.05% nasal solution and Sodium Hypochlorite Solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
Aug 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
  • -

Who cannot join

  • • Patients:
  • Uncooperative children.
  • Medically compromised children.
  • Patients whose parents refuse to participate or refuse to sign the informed consent.
  • Teeth:
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  • Previously accessed molars.
  • Mobile primary molars.
  • Presence of sinus tract or pain on percussion.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mariam Medhat, Master's Degree candidate contact

01011914614 ext. +2

mariam.abdelsameea@dentistry.cu.edu.eg

Egypt1 site
  • Faculty of dentistry, Cairo University.

    Cairo

    Cairo University, 0223634965, dentmail@dentistry.cu.edu.eg

Other trials in Egypt

About this study

Official title: 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.

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.

Being tested
Oxymetazoline 0.05% nasal solution, Sodium Hypochlorite Solution
Keywords
Pulp therapy in primary molars, pulpotomy, MTA pulpotomy for primary molars, Sodium hypochlorite, Oxymetazoline, Hemostatic agents, NaOCl, Oxy, Oxymetazoline nasal spray
Medical subject headings
Dental Pulp Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxymetazoline 0.05% nasal solutionOther

    Also called Normifrin, Oxymet, OXY

    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.

  • Sodium Hypochlorite SolutionOther

    Also called NaOCl

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

Study groups in NCT07675330
Study groupRoleWhat they receive
Using sodium hypochlorite as hemostatic agent in MTA pulpotomy of primary molarsActive comparatorCompression 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
Receives: Other: Sodium Hypochlorite Solution
Using Oxymetazoline as hemostatic agent in MTA pulpotomy of primary molars.ExperimentalUsing 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.
Receives: Other: Oxymetazoline 0.05% nasal solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Success.

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

    Measured: 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

    Measured: 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)

    Measured: 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)

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

Secondary outcomes (3)
  1. Radiographic success.

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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07675330
Sponsor's protocol ID
CairoUni-PEDO-2026-06-16-Int-1
Acronym
OXY - MTA
Status last verified
Jun 2026
First submitted
23 Jun 2026
Last updated
30 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Oxymetazoline 0.05% nasal solution and Sodium Hypochlorite Solution in people with Pulp Disease, Dental and Pulp Therapy in Primary Molars, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mariam Medhat, Master's Degree candidate (01011914614 ext. +2, mariam.abdelsameea@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Success. (time frame: Clinical evaluation will be performed at 1,3 &6 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07675330, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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