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

NCT07675330 | Not Yet Recruiting

• 1 other identifier: CairoUni-PEDO-2026-06-16-Int-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Clinical Success.

  •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

  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:

  • 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

  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.

Secondary Outcomes (3)

• Radiographic success.

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

• Radiographic success

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

• Radiographic succces

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

Study Arms (2)

Using sodium hypochlorite as hemostatic agent in MTA pulpotomy of primary molars

ACTIVE COMPARATOR

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

Using Oxymetazoline as hemostatic agent in MTA pulpotomy of primary molars.

EXPERIMENTAL

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

Oxymetazoline 0.05% nasal solution OTHER

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

Using Oxymetazoline as hemostatic agent in MTA pulpotomy of primary molars.

Sodium Hypochlorite Solution OTHER

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

Also known as: NaOCl

Using sodium hypochlorite as hemostatic agent in MTA pulpotomy of primary molars

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry, Cairo University.

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 41597036 BACKGROUND

• 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.

  PMID: 41369231 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Oxymetazoline; Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Central Study Contacts

Mariam Medhat, Master's Degree candidate

CONTACT

01011914614; mariam.abdelsameea@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric dentistry resident

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)