Carious Anterior TeethZO-OOONCT07265089
Zinc Oxide-Ozonated Olive Oil vs Metapex in Primary Anterior Teeth
A study testing Zinc Oxide-Ozonated Olive Oil and Metapex in people with Carious Anterior Teeth, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Anterior Teeth
- What is being tested?
- Zinc Oxide-Ozonated Olive Oil and Metapex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 3-5 years.
- Primary anterior teeth requiring root canal treatment due to irreversible pulpitis.
- Cooperative behavior child.
- Parents provided written informed consent. -
Who cannot join
- Medically compromised children.
- Tooth with advanced root resorption.
- Non-restorable crown structures.
- Tooth with abscess or fistula.
- Allergies or hypersensitivity to any of the materials used e.g., zinc oxide, olive oil, or calcium hydroxide and Idoform (components of Metapex).
- Unable to attend follow-up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Raheeq Babiker Ibrahim Babiker, Master degree contact
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate
Faculty of Dentistry, Cairo University, 0020223642705, rec@dentistry.cu.edu.eg
About this study
Official title: 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
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.
Read the 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
- Being tested
- Zinc Oxide-Ozonated Olive Oil, Metapex
- Keywords
- "Zinc Oxide", "Ozonated Olive Oil", "Metapex", "Primary Teeth", "Pulpectomy", "Randomized Clinical Trial".
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc Oxide-Ozonated Olive OilOther
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.
MetapexOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A Zinc Oxide-Ozonated Olive Oil | Experimental | Zinc oxide powder will be mixed with ozonated olive oil until a creamy, workable consistency is achieved. Receives: Other: Zinc Oxide-Ozonated Olive Oil |
| Group B Metapex | Experimental | Premixed calcium hydroxide with iodoform paste Receives: Other: Metapex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success: absence of pain, swelling, tenderness, or mobility
Measured: 12 month intervals T0: 0 T1: 3month T2: 6month T3: 9month T4: 12month
Secondary outcomes (1)
Radiographic success: absence of periapical radiolucency or root resorption
Measured: 12 month intervals T0:0 T2: 6 month T4: 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious Anterior TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raheeq Babiker Ibrahim Babiker, Cairo University
- Investigators
- Adel Elbardissy Professor of Pediatric Dentistry and Dental Public Health, Prof. Doctor, Study director, Faculty of Dentistry, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265089
- Sponsor's protocol ID
- CU-PEDO-ZOO vs MTX
- Acronym
- ZO-OOO
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07265089
- Acronym / sponsor ID
- ZO-OOO / CU-PEDO-ZOO vs MTX
- Conditions
- Carious Anterior Teeth
- Keywords
- "Zinc Oxide", "Ozonated Olive Oil", "Metapex", "Primary Teeth", "Pulpectomy", "Randomized Clinical Trial".
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Zinc Oxide-Ozonated Olive Oil | Experimental | Other: Zinc Oxide-Ozonated Olive OilZinc oxide powder will be mixed with ozonated olive oil until a creamy, workable consistency is achieved. |
| Group B Metapex | Experimental | Other: MetapexPremixed calcium hydroxide with iodoform paste |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 3-5 years.
- Primary anterior teeth requiring root canal treatment due to irreversible pulpitis.
- Cooperative behavior child.
- Parents provided written informed consent. -
Key exclusion criteria (6 listed)
- Medically compromised children.
- Tooth with advanced root resorption.
- Non-restorable crown structures.
- Tooth with abscess or fistula.
- Allergies or hypersensitivity to any of the materials used e.g., zinc oxide, olive oil, or calcium hydroxide and Idoform (components of Metapex).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Oxide-Ozonated Olive OilChildren 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 | Group A Zinc Oxide-Ozonated Olive Oil |
| MetapexChildren 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. | Other | Group B Metapex |
Primary outcome
Clinical success: absence of pain, swelling, tenderness, or mobility
Time frame: 12 month intervals T0: 0 T1: 3month T2: 6month T3: 9month T4: 12month
1 secondary outcome
Radiographic success: absence of periapical radiolucency or root resorption
Time frame: 12 month intervals T0:0 T2: 6 month T4: 12month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raheeq Babiker Ibrahim Babiker, Master degree contact
Adel Elbardissy Professor of Pediatric Dentistry and Dental Public Health, Prof. Doctor study director
Faculty of Dentistry, Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc Oxide-Ozonated Olive Oil and Metapex in people with Carious Anterior Teeth, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raheeq Babiker Ibrahim Babiker, Master degree (+201145501017, raheeq.babiker@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success: absence of pain, swelling, tenderness, or mobility (time frame: 12 month intervals T0: 0 T1: 3month T2: 6month T3: 9month T4: 12month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.