Irreversible Pulpitis (toothache)NCT06755502
Garlic Oil As Root Filling Material in Primary Molars
A study testing Garlic oil and Calcium Hydroxide, Iodoform, paste in people with Irreversible Pulpitis (toothache), run by Cairo University.
Trial summary
The goal of this study is to test garlic oil mixed with zinc oxide as a potential root canal filling material of primary molars in children aged from four to eight years. the study hypothesized that garlic oil mixed with zinc oxide would be the same as the gold standard filling material (metapex). Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis (toothache)
- What is being tested?
- Garlic oil and Calcium Hydroxide, Iodoform, paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 8 Aug 2025to 8 Nov 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary second molars which are diagnosed with irreversible pulpitis, or pulp necrosis.
- Presence of sinus tract.
- Periapical bone swelling.
- Continuous bleeding after amputation of the coronal pulp tissue.
- No pulp tissue remains when the pulp chamber is accessed.
- Pus discharges from the canal.
- Radiographically, only primary molars with at least two-thirds of the root length.
- Presence of inter-radicular or periapical radiolucency.
Who cannot join
- 1. A tooth with internal root resorption will not be included. 2. Excessive tooth mobility beyond healing. 3. Carious perforation in the pulpal flour. 4. A tooth with a pathological lesion extending to the successor's tooth germ. 5. Non-restorable primary molars.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Allium Sativum As Root Filling Material for Primary Molars Indicated for Non Vital Pulp Therapy: Randomized Clinical Trials
The goal of this study is to test garlic oil mixed with zinc oxide as a potential root canal filling material of primary molars in children aged from four to eight years.
the study hypothesized that garlic oil mixed with zinc oxide would be the same as the gold standard filling material (metapex).
The group receiving the garlic oil with zinc oxide as root canal filling material will be compared with other similar group receiving metapex as root canal filling material in terms of clinical and radio-graphic success, and working time.
Read the detailed description
This study is a randomized clinical trial (RCT), that aims compare the clinical and radio-graphic success of garlic oil mixed with zinc oxide, used as root canal filling material in primary molars in children aged from four to eight years, with the conventional root filling material, which is metapex.
- Conditions
- Irreversible Pulpitis (toothache)
- Being tested
- Garlic oil, Calcium Hydroxide, Iodoform, paste
- Keywords
- RCT, garlic oil, natural remedies, primary molars, root canal filling material
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garlic oilCombination product
garlic oil mixed with zinc oxid powder, as root canal filling material
Calcium Hydroxide, Iodoform, pasteDrug
Also called metapex
Metapex as root canal filling materials
| Study group | Role | What they receive |
|---|---|---|
| garlic oil with zinc oxide group | Experimental | Not described Receives: Combination Product: Garlic oil |
| metapex group | Active comparator | Not described Receives: Drug: Calcium Hydroxide, Iodoform, paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical success rate
The criteria of successful treatment, according to which the clinical evaluation will be done, will be "No abnormal mobility", "No sensitivity to percussion", and "No swelling"
Measured: 3, 6,9,and 12 months
Radio-graphic success
For the radiographic success, the evaluation criteria will be "Preoperative pathological inter-radicular and/or periapical radiolucency started to resolve, or remained the same size", "No new postoperative pathological radiolucency developed", and "No pathological internal or external root resorption"
Measured: 6, and 12 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start8 Aug 2025 (estimated)
- Primary completion8 Oct 2026 (estimated)
- Study completion8 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible Pulpitis (toothache)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Allah Ashraf Abd Elsabour Abd Elkareem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755502
- Sponsor's protocol ID
- 555
- Status last verified
- Mar 2025
- First submitted
- 25 Dec 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Allium Sativum As Root Filling Material for Primary Molars Indicated for Non Vital Pulp Therapy: Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT06755502
- Acronym / sponsor ID
- 555
- Conditions
- Irreversible Pulpitis (toothache)
- Keywords
- RCT, garlic oil, natural remedies, primary molars, root canal filling material
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Aug 2025 (estimated)
- Primary completion
- 8 Oct 2026 (estimated)
- Study completion
- 8 Nov 2026 (estimated)
- First posted
- 1 Jan 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.
The goal of this study is to test garlic oil mixed with zinc oxide as a potential root canal filling material of primary molars in children aged from four to eight years.
the study hypothesized that garlic oil mixed with zinc oxide would be the same as the gold standard filling material (metapex).
The group receiving the garlic oil with zinc oxide as root canal filling material will be compared with other similar group receiving metapex as root canal filling material in terms of clinical and radio-graphic success, and working time.
Detailed description
This study is a randomized clinical trial (RCT), that aims compare the clinical and radio-graphic success of garlic oil mixed with zinc oxide, used as root canal filling material in primary molars in children aged from four to eight years, with the conventional root filling material, which is metapex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| garlic oil with zinc oxide group | Experimental | Combination Product: Garlic oil |
| metapex group | Active comparator | Drug: Calcium Hydroxide, Iodoform, paste |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Primary second molars which are diagnosed with irreversible pulpitis, or pulp necrosis.
- Presence of sinus tract.
- Periapical bone swelling.
- Continuous bleeding after amputation of the coronal pulp tissue.
- No pulp tissue remains when the pulp chamber is accessed.
Key exclusion criteria (2 listed)
- 1. A tooth with internal root resorption will not be included. 2. Excessive tooth mobility beyond healing. 3. Carious perforation in the pulpal flour. 4. A tooth with a pathological lesion extending to the successor's tooth germ. 5. Non-restorable primary molars.
- -
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 |
|---|---|---|
| Garlic oilgarlic oil mixed with zinc oxid powder, as root canal filling material | Combination product | garlic oil with zinc oxide group |
| Calcium Hydroxide, Iodoform, pasteAlso: metapexMetapex as root canal filling materials | Drug | metapex group |
Primary outcome
The clinical success rate
Time frame: 3, 6,9,and 12 months
The criteria of successful treatment, according to which the clinical evaluation will be done, will be "No abnormal mobility", "No sensitivity to percussion", and "No swelling"
Radio-graphic success
Time frame: 6, and 12 month.
For the radiographic success, the evaluation criteria will be "Preoperative pathological inter-radicular and/or periapical radiolucency started to resolve, or remained the same size", "No new postoperative pathological radiolucency developed", and "No pathological internal or external root resorption"
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 20 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Garlic oil and Calcium Hydroxide, Iodoform, paste in people with Irreversible Pulpitis (toothache), run by Cairo University.
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 8 inclusion and 2 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 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Mennat Allah A. A. Elkareem (+20 1026022605, mennatallah.ashraf@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical success rate (time frame: 3, 6,9,and 12 months). The study lists 2 primary outcomes in all. 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 20 Mar 2025.