Mineral Trioxide AggregatePhase 2NCT06637761
Clinical and Radio-graphic Evaluation of Non-staining Bio-active Bio-ceramic (Neo MTA 2) in Revascularization
A Phase 2 study testing NeoMTA2 and WMTA in people with Mineral Trioxide Aggregate, run by Cairo University.
Trial summary
The study will compare the clinical and radio-graphic performance of newly introduced non-staining bio-active bio-ceramic (Neo MTA 2) versus White MTA used as coronal plug material in revascularization of non-vital immature permanent anterior teeth.Visual examination, palpation, A measuring scale in digital… Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Mineral Trioxide Aggregate
- What is being tested?
- NeoMTA2 and WMTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2024to 30 Dec 2025
- Phase
- Phase 2
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cooperative patient/ compliant parents or guardians
- Patients free from any systemic diseases that hinder the normal healing process according to parental history
- Necrotic immature permanent anterior teeth
- Enough coronal portion of teeth that does not necessitate post and core for final restoration
Who cannot join
- Patients having an allergy to medicament and antibiotics necessary to complete the procedure
- Teeth with internal or external root resorption
- Uncooperative patients/ in-compliant parents or guardians
- Laxative injuries
- Avulsed tooth after re-plantation
- Compromised remaining coronal structure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radio-graphic Evaluation of Bio-active Bio-ceramic (Neo MTA 2) Versus White MTA Used as Coronal Plug Material in Revascularization of Non-vital Immature Permanent Anterior Teeth: A Randomized Clinical Trial
The study will compare the clinical and radio-graphic performance of newly introduced non-staining bio-active bio-ceramic (Neo MTA 2) versus White MTA used as coronal plug material in revascularization of non-vital immature permanent anterior teeth.Visual examination, palpation, A measuring scale in digital radio-graph software (DIGORA for Windows software) will be used for evaluation.
Read the detailed description
Mineral trioxide aggregate (MTA) has been widely used in revascularization procedures for coronal sealing in more than 85% of studies for privilege of bio compatibility, good sealing properties, and marginal adaptation. However, its poor handling characteristics and potential coronal discoloration effects are the major disadvantages of using mineral trioxide aggregate.
Although white MTA (WMTA) has been developed to overcome the tooth discoloration caused by the application of grey MTA, several in vivo and in vitro studies have also reported tooth discoloration after using WMTA.
To overcome the problems associated with WMTA, a new modification was introduced to the market called NeoMTA 2 as a new hope to overcome the discoloration problem. NeoMTA 2 provides easier handling, shorter setting time, and better color. The lack of post-operative discoloration problems was mainly due to the absence of Bismuth oxide in NeoMTA.
up to date, no clinical trials have reported the clinical and radio-graphic outcomes after revascularization of non-vital immature permanent anterior teeth using Neo MTA 2. Thus, the present study aims to evaluate and compare clinically and radio-graphically the effect of using two different coronal plug materials (Neo MTA 2 versus White mineral trioxide aggregate) in revascularization of non-vital immature permanent anterior teeth.
- Conditions
- Mineral Trioxide Aggregate
- Being tested
- NeoMTA2, WMTA
- Keywords
- bioactive bioceramic, discoloration, revascularization, mineral trioxide aggregate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoMTA2Drug
Also called Nu smile,USA
Bio-active bio-ceramic mineral trioxide aggregate
WMTADrug
Also called Angulus, Brazil
White Mineral trioxide aggregates
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | NeoMTA 2
Manipulation and mixing will be done according to manufacturer instructions:
* 1 scoop (0.1gm) of NeoMTA 2 Powder will be dispensed on a glass slab. Then two drops of NeoMTA 2 Gel will be dispensed next to the powder.
* Gradually as much Gel as necessary will be added to the Powder to achieve the desired consistency. The Gel will be incorporated by spatula-ting the Powder/Gel mixture firmly against the glass slab to ensure all of the Powder is thoroughly witted by the Gel. Receives: Drug: NeoMTA2 |
| Group II | Active comparator | White mineral trioxide aggregate
* One spoon of powder and one drop of distilled water are dispensed on a sterile glass slab.
* A metal spatula will be used to gradually mix the liquid and powder together for 30 seconds to ensure full wetting of the powder particles and to obtain a consistency similar to wet sand.
* 3-4 mm of white MTA will be placed over the clot carefully by using an amalgam carrier.
The mix will be placed over the collagen matrix 2mm beneath the clinical cement-enamel junction. Receives: Drug: WMTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discoloration
Using shade guide (VITA classical)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start5 Oct 2024 (estimated)
- Primary completion6 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mineral Trioxide AggregateStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr University for Science and Technology
- Responsible party
- Principal investigator, Ola mourad, Cairo University
- Investigators
- Youssef, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637761
- Sponsor's protocol ID
- Cairo U Clinical
- Status last verified
- Oct 2024
- First submitted
- 19 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radio-graphic Evaluation of Bio-active Bio-ceramic (Neo MTA 2) Versus White MTA Used as Coronal Plug Material in Revascularization of Non-vital Immature Permanent Anterior Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06637761
- Acronym / sponsor ID
- Cairo U Clinical
- Conditions
- Mineral Trioxide Aggregate
- Keywords
- bioactive bioceramic, discoloration, revascularization, mineral trioxide aggregate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Misr University for Science and Technology
- Study start
- 5 Oct 2024 (estimated)
- Primary completion
- 6 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (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 study will compare the clinical and radio-graphic performance of newly introduced non-staining bio-active bio-ceramic (Neo MTA 2) versus White MTA used as coronal plug material in revascularization of non-vital immature permanent anterior teeth.Visual examination, palpation, A measuring scale in digital radio-graph software (DIGORA for Windows software) will be used for evaluation.
Detailed description
Mineral trioxide aggregate (MTA) has been widely used in revascularization procedures for coronal sealing in more than 85% of studies for privilege of bio compatibility, good sealing properties, and marginal adaptation. However, its poor handling characteristics and potential coronal discoloration effects are the major disadvantages of using mineral trioxide aggregate.
Although white MTA (WMTA) has been developed to overcome the tooth discoloration caused by the application of grey MTA, several in vivo and in vitro studies have also reported tooth discoloration after using WMTA.
To overcome the problems associated with WMTA, a new modification was introduced to the market called NeoMTA 2 as a new hope to overcome the discoloration problem. NeoMTA 2 provides easier handling, shorter setting time, and better color. The lack of post-operative discoloration problems was mainly due to the absence of Bismuth oxide in NeoMTA.
up to date, no clinical trials have reported the clinical and radio-graphic outcomes after revascularization of non-vital immature permanent anterior teeth using Neo MTA 2. Thus, the present study aims to evaluate and compare clinically and radio-graphically the effect of using two different coronal plug materials (Neo MTA 2 versus White mineral trioxide aggregate) in revascularization of non-vital immature permanent anterior teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: NeoMTA2NeoMTA 2 Manipulation and mixing will be done according to manufacturer instructions: * 1 scoop (0.1gm) of NeoMTA 2 Powder will be dispensed on a glass slab. Then two drops of NeoMTA 2 Gel will be dispensed next to the powder. * Gradually as much Gel as necessary will be added to the Powder to achieve the desired consistency. The Gel will be incorporated by spatula-ting the Powder/Gel mixture firmly against the glass slab to ensure all of the Powder is thoroughly witted by the Gel. |
| Group II | Active comparator | Drug: WMTAWhite mineral trioxide aggregate * One spoon of powder and one drop of distilled water are dispensed on a sterile glass slab. * A metal spatula will be used to gradually mix the liquid and powder together for 30 seconds to ensure full wetting of the powder particles and to obtain a consistency similar to wet sand. * 3-4 mm of white MTA will be placed over the clot carefully by using an amalgam carrier. The mix will be placed over the collagen matrix 2mm beneath the clinical cement-enamel junction. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Cooperative patient/ compliant parents or guardians
- Patients free from any systemic diseases that hinder the normal healing process according to parental history
- Necrotic immature permanent anterior teeth
- Enough coronal portion of teeth that does not necessitate post and core for final restoration
Key exclusion criteria (6 listed)
- Patients having an allergy to medicament and antibiotics necessary to complete the procedure
- Teeth with internal or external root resorption
- Uncooperative patients/ in-compliant parents or guardians
- Laxative injuries
- Avulsed tooth after re-plantation
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 |
|---|---|---|
| NeoMTA2Also: Nu smile,USABio-active bio-ceramic mineral trioxide aggregate | Drug | Group I |
| WMTAAlso: Angulus, BrazilWhite Mineral trioxide aggregates | Drug | Group II |
Primary outcome
Discoloration
Time frame: 1 year
Using shade guide (VITA classical)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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. This study is not recruiting at the moment.
Youssef study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NeoMTA2 and WMTA in people with Mineral Trioxide Aggregate, 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 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. 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 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.
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?
Contact Ola Mourad, Msc (01062952921, ola.abdelkader@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discoloration (time frame: 1 year). 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 15 Oct 2024.