NCT07265089

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: Egypt