Zinc Oxide-Ozonated Olive Oil vs Metapex in Primary Anterior Teeth (ZO-OOO)

Clinical and Radiographic Evaluation of Success Rate of Zinc Oxide-Ozonated Olive Oil Versus Metapex as Root Canal Filling Materials in Primary Anterior Teeth: Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carious Anterior Teeth
• Intervention / Treatment: Other: Zinc Oxide-Ozonated Olive Oil; Other: Metapex

Detailed Description

Dental caries in primary anterior teeth significantly compromises aesthetics and function, particularly affecting children's psychosocial well-being and oral development. Esthetically, carious lesions in these visible teeth can lead to social avoidance, reduced self-esteem, and bullying risks, as children may avoid smiling or participating in activities. Pulpectomy of primary teeth is a critical to maintain arch integrity, function, and aesthetics in the pediatric population. Zinc oxide eugenol (ZOE) has been the most commonly used filling material in pulptherapy of primary teeth, achieving moderate to high success rates exceeding 90%. However, the slow resorption rate, which may not match the physiological root resorption of primary teeth, potentially leading to delayed natural exfoliation and complications with the eruption of permanent successors. it can also induce necrosis and delayed healing.

(ZOE) can cause irritation and sensitivity when in contact with oral tissues, primarily due to the eugenol component. Eugenol is recognized as a sensitizer and can induce both localized irritation and hypersensitivity reactions, including contact dermatitis, contact stomatitis, and, in rare cases, immediate allergic responses such as urticaria and generalized itching shortly after application.

Olive oil is a vegetal oil it contains antioxidants that enhance properties which can potentially overcome the limited antimicrobial activity of traditional ZOE. Ozonated olive oil has demonstrated excellent biocompatibility with surrounding tissues. This reduces the adverse reactions or irritation, making it a safer alternative for pediatric patients. Zinc oxide-ozonated olive oil may reduce the chances of overfilling and subsequent eruption complications. Promotes tissue repair and healing due to its anti-inflammatory and regenerative properties. This can contribute to quicker recovery and better clinical outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raheeq Babiker Ibrahim Babiker, Master degree; Phone Number: +201145501017; Email: raheeq.babiker@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt
      • Faculty of Dentistry, Cairo University
      • Contact: Faculty of Dentistry, Cairo University; Phone Number: 0020223642705; Email: rec@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A Zinc Oxide-Ozonated Olive Oil; Zinc oxide powder will be mixed with ozonated olive oil until a creamy, workable consistency is achieved.	Other: Zinc Oxide-Ozonated Olive Oil; 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.
Experimental: Group B Metapex; Premixed calcium hydroxide with iodoform paste	Other: Metapex; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical success: absence of pain, swelling, tenderness, or mobility	12 month intervals T0: 0 T1: 3month T2: 6month T3: 9month T4: 12month

Secondary Outcome Measures

Outcome Measure	Time Frame
Radiographic success: absence of periapical radiolucency or root resorption	12 month intervals T0:0 T2: 6 month T4: 12month

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Adel Elbardissy Professor of Pediatric Dentistry and Dental Public Health, Prof. Doctor, Faculty of Dentistry, Cairo University, Egypt

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: "Zinc Oxide", "Ozonated Olive Oil", "Metapex", "Primary Teeth", "Pulpectomy", "Randomized Clinical Trial".
• Additional Relevant MeSH Terms: Metapex
• Other Study ID Numbers: CU-PEDO-ZOO vs MTX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No