Zinc Oxide-Ozonated Olive Oil vs Metapex in Primary Anterior Teeth

NCT07265089 | Not Yet Recruiting

• 1 other identifier: CU-PEDO-ZOO vs MTX
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial compares zinc oxide-ozonated olive oil and Metapex as root canal filling materials in primary anterior teeth of children aged 3-5 years. The study aims to evaluate their clinical and radiographic success over 12 months.Clinical evaluation includes pain, swelling, and mobility; radiographic evaluation includes periapical healing and resorption.

Conditions

Carious Anterior Teeth

Keywords

"Zinc Oxide", "Ozonated Olive Oil", "Metapex", "Primary Teeth", "Pulpectomy", "Randomized Clinical Trial".

Outcome Measures

Primary Outcomes (1)

• Clinical success: absence of pain, swelling, tenderness, or mobility

  12 month intervals T0: 0 T1: 3month T2: 6month T3: 9month T4: 12month

Secondary Outcomes (1)

• Radiographic success: absence of periapical radiolucency or root resorption

  12 month intervals T0:0 T2: 6 month T4: 12month

Study Arms (2)

Group A Zinc Oxide-Ozonated Olive Oil

EXPERIMENTAL

Zinc oxide powder will be mixed with ozonated olive oil until a creamy, workable consistency is achieved.

Other: Zinc Oxide-Ozonated Olive Oil

Group B Metapex

EXPERIMENTAL

Premixed calcium hydroxide with iodoform paste

Other: Metapex

Interventions

Zinc Oxide-Ozonated Olive Oil OTHER

Children aged 3-5 years with primary anterior teeth requiring pulpectomy will receive treatment under rubber dam isolation. After achieving local anesthesia, an access cavity will be prepared using sterile round burs with water coolant. Working length will be determined using an apex locator, and biomechanical preparation will be performed with K-files.Irrigation will be done with normal saline and 1% sodium hypochlorite, followed by drying with paper points. The canal will then be obturated with a freshly prepared mixture of zinc oxide powder and ozonated olive oil placed using a lentulo spiral, avoiding overfilling. The access cavity will be sealed with glass ionomer and restored with light-cured composite. Follow-up will occur at 3, 6, 9, and 12 months.

Group A Zinc Oxide-Ozonated Olive Oil

Metapex OTHER

Children aged 3-5 years with primary anterior teeth requiring pulpectomy will receive treatment under rubber dam isolation. After achieving local anesthesia, an access cavity will be prepared using sterile round burs with water coolant. Working length will be determined using an apex locator, and biomechanical preparation will be performed with K-files.and irrigation with normal saline and 1% sodium hypochlorite. After drying, the root canal will be filled with Metapex (premixed calcium hydroxide and iodoform paste) delivered via syringe with a fine tip until proper fill is confirmed radiographically. The canal will then be sealed with glass ionomer and restored with light-cured composite. Follow-up will be performed at 3, 6, 9, and 12 months.

Group B Metapex

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3-5 years.
• Primary anterior teeth requiring root canal treatment due to irreversible pulpitis.
• Cooperative behavior child.
• Parents provided written informed consent. -

You may not qualify if:

• Medically compromised children.
• Tooth with advanced root resorption.
• Non-restorable crown structures.
• Tooth with abscess or fistula.
• Allergies or hypersensitivity to any of the materials used e.g., zinc oxide, olive oil, or calcium hydroxide and Idoform (components of Metapex).
• Unable to attend follow-up visits.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Interventions

Metapex

Study Officials

• Adel Elbardissy Professor of Pediatric Dentistry and Dental Public Health, Prof. Doctor

  Faculty of Dentistry, Cairo University, Egypt

  STUDY DIRECTOR

Central Study Contacts

Raheeq Babiker Ibrahim Babiker, Master degree

CONTACT

+201145501017; raheeq.babiker@dentistry.cu.edu.eg

Study Design

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

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)