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

NCT07265089 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-12-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Adel Elbardissy Professor of Pediatric Dentistry and Dental Public Health, Prof. Doctor · Faculty of Dentistry, Cairo University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07265089 on ClinicalTrials.gov