Carious Primary MolarsPhase 2/3NCT04903808
Clinical And Cost- Effectiveness of Allium Sativum Oil (Garlic Oil ) Versus Mineral Trioxide Aggregate in Primary Molars Pulpotomy in Group of Egyptian Children : A Randomised Clinical Pilot Study.
A Phase 2/3 study testing Allium Sativum Oil and Mineral Tri-Oxide Aggregate in people with Carious Primary Molars, run by Cairo University.
Trial summary
Allium Sativum oil is advocated to prove the capability of new natural products in replacing higher cost pharmacological materials, while achieving the same successful clinical and radiographic long-term results. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Primary Molars
- What is being tested?
- Allium Sativum Oil and Mineral Tri-Oxide Aggregate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Oct 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy children aged from 5- 7 years.
- Children not having antibiotics in the past 14 days.
- Cooperative children.
- Children are having at least two carious asymptomatic second primary molars.
Who cannot join
- Uncooperative children.
- Immunocompromised children.
- Children with clinical or radiographic symptoms
About this study
Official title: Clinical And Cost- Effectiveness of Allium Sativum Oil Versus Mineral Trioxide Aggregate in Primary Molars Pulpotomy in Group of Egyptian Children : A Randomised Clinical Pilot Study.
Allium Sativum oil is advocated to prove the capability of new natural products in replacing higher cost pharmacological materials, while achieving the same successful clinical and radiographic long-term results.
Read the detailed description
One of the most challenging subjects in paediatric dentistry is choosing the ideal pulp medication material that has the required properties such as preserving the vitality of the remaining intact pulp and stimulating its repair. This material should prevent pathological root resorption.Clinical and cost effectiveness trials from different countries are useful to determine which medicament should be advocated in which economic setting . Alternative pulpotomy materials clinically effective as MTA but with lower cost should be studied .
- Conditions
- Carious Primary Molars
- Being tested
- Allium Sativum Oil, Mineral Tri-Oxide Aggregate
- Keywords
- Allium sativum oil, MTA, pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allium Sativum OilDrug
Also called Garlic oil
Garlic oil Captain Company (CAP-PHARM)
Mineral Tri-Oxide AggregateDrug
Also called MTA
ProRoot MTA, Dentsply
| Study group | Role | What they receive |
|---|---|---|
| Allium sativum oil | Experimental | The pulp stumps of the molars are dressed with a cotton pellet that is made damp with Allium Sativum oil for 1 min . Receives: Drug: Allium Sativum Oil |
| Mineral Trioxide Aggregate | Active comparator | The material will be prepared according to the manufacturer's instructions , applied to the pulp chamber and a moistened cotton pellet was placed over the MTA paste to allow the material to set. Receives: Drug: Mineral Tri-Oxide Aggregate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effectiveness
clinical effectiveness will be measured by intraoral examination and radiographic assessment
Measured: 1 year follow up
Secondary outcomes (1)
Cost-effectiveness
cost-effectiveness will be measured with incremental cost-effectiveness ratio (ICER)
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study startSep 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious Primary MolarsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a double-blinded randomised clinical trial with equal randomisation parallel design with allocation ratio 1:1
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lobna Magdy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903808
- Sponsor's protocol ID
- Lobnamagdy128
- Status last verified
- Aug 2021
- First submitted
- 20 May 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Cost- Effectiveness of Allium Sativum Oil Versus Mineral Trioxide Aggregate in Primary Molars Pulpotomy in Group of Egyptian Children : A Randomised Clinical Pilot Study.
- ClinicalTrials.gov ID
- NCT04903808
- Acronym / sponsor ID
- Lobnamagdy128
- Conditions
- Carious Primary Molars
- Keywords
- Allium sativum oil, MTA, pulpotomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 27 May 2021 (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.
Allium Sativum oil is advocated to prove the capability of new natural products in replacing higher cost pharmacological materials, while achieving the same successful clinical and radiographic long-term results.
Detailed description
One of the most challenging subjects in paediatric dentistry is choosing the ideal pulp medication material that has the required properties such as preserving the vitality of the remaining intact pulp and stimulating its repair. This material should prevent pathological root resorption.Clinical and cost effectiveness trials from different countries are useful to determine which medicament should be advocated in which economic setting . Alternative pulpotomy materials clinically effective as MTA but with lower cost should be studied .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- It is a double-blinded randomised clinical trial with equal randomisation parallel design with allocation ratio 1:1
| Arm | Type | Receives |
|---|---|---|
| Allium sativum oil | Experimental | Drug: Allium Sativum OilThe pulp stumps of the molars are dressed with a cotton pellet that is made damp with Allium Sativum oil for 1 min . |
| Mineral Trioxide Aggregate | Active comparator | Drug: Mineral Tri-Oxide AggregateThe material will be prepared according to the manufacturer's instructions , applied to the pulp chamber and a moistened cotton pellet was placed over the MTA paste to allow the material to set. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Apparently healthy children aged from 5- 7 years.
- Children not having antibiotics in the past 14 days.
- Cooperative children.
- Children are having at least two carious asymptomatic second primary molars.
Key exclusion criteria (3 listed)
- Uncooperative children.
- Immunocompromised children.
- Children with clinical or radiographic symptoms
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 |
|---|---|---|
| Allium Sativum OilAlso: Garlic oilGarlic oil Captain Company (CAP-PHARM) | Drug | Allium sativum oil |
| Mineral Tri-Oxide AggregateAlso: MTAProRoot MTA, Dentsply | Drug | Mineral Trioxide Aggregate |
Primary outcome
Clinical effectiveness
Time frame: 1 year follow up
clinical effectiveness will be measured by intraoral examination and radiographic assessment
1 secondary outcome
Cost-effectiveness
Time frame: 1 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Allium Sativum Oil and Mineral Tri-Oxide Aggregate in people with Carious Primary Molars, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Aug 2021. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effectiveness (time frame: 1 year follow up). 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 25 Aug 2021.