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
Sponsor study identifier
interventional
52
1 country
1
Study Start
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 24, 2025
Actual (reported)December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 4, 2025
Actual (reported)December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Clinical success: absence of pain, swelling, tenderness, or mobility
12 month intervals T0: 0 T1: 3month T2: 6month T3: 9month T4: 12month
Radiographic success: absence of periapical radiolucency or root resorption
12 month intervals T0:0 T2: 6 month T4: 12month
Zinc oxide powder will be mixed with ozonated olive oil until a creamy, workable consistency is achieved.
Premixed calcium hydroxide with iodoform paste
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.
Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate, Egypt
Adel Elbardissy Professor of Pediatric Dentistry and Dental Public Health, Prof. Doctor
Faculty of Dentistry, Cairo University, Egypt
First Submitted
November 24, 2025
First Posted
December 4, 2025
Study Start
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
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.
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December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 4, 2025
Record last verified: 2025-10
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Source: ClinicalTrials.gov.
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