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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Carious Anterior Teeth

Treatments: Other: Zinc Oxide-Ozonated Olive Oil; Other: Metapex

Study type: Interventional

Funder types: Other

Identifiers

NCT07265089

CU-PEDO-ZOO vs MTX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Group A Zinc Oxide-Ozonated Olive Oil

Experimental group

Description:

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

Treatment:

Other: Zinc Oxide-Ozonated Olive Oil

Group B Metapex

Experimental group

Description:

Premixed calcium hydroxide with iodoform paste

Treatment:

Other: Metapex