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

NCT ID: NCT07265089

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-12-01

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.

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.

Conditions

Carious Anterior Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A Zinc Oxide-Ozonated Olive Oil

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

Group Type: EXPERIMENTAL

Zinc Oxide-Ozonated Olive Oil

Intervention Type: 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 B Metapex

Premixed calcium hydroxide with iodoform paste

Group Type: EXPERIMENTAL

Metapex

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Raheeq Babiker Ibrahim Babiker

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: STUDY_DIRECTOR

Faculty of Dentistry, Cairo University, Egypt

Locations

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Central Contacts

Raheeq Babiker Ibrahim Babiker, Master degree

Role: CONTACT

raheeq.babiker@dentistry.cu.edu.eg

+201145501017

Facility Contacts

Faculty of Dentistry, Cairo University

Role: primary

rec@dentistry.cu.edu.eg

0020223642705

Other Identifiers

CU-PEDO-ZOO vs MTX

Identifier Type: -

Identifier Source: org_study_id