PulpotomyPhase 3MTANCT06219824
Clinical and Radiographic Evaluation of Bioceramic Putty MTA Versus MTA in Pulpotomy of Immature Permanent Molars
A Phase 3 study testing premixed Bio-ceramic MTA and Conventional MTA in people with Pulpotomy and Deep Caries, run by Cairo University at 1 site in Egypt.
Trial summary
The present study aims to evaluate the clinical and radiographic success of bioceramics putty MTA versus MTA in the pulpotomy of immature permanent molars The main question it aims to answer is: Will the biocermaics putty MTA have higher clinical and radiographic success rates than MTA in pulpotomy of immature… Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy, Deep Caries
- What is being tested?
- premixed Bio-ceramic MTA and Conventional MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 30 Nov 2025
- Phase
- Phase 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged from 6-8 years of both sexes have immature permanent molars
- with deep carious lesions indicated for pulpotomy.
- Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
- Permanent molars without any clinical sign of pulp necrosis including swelling, fistula, pain on percussion, and pathologic tooth mobility.
- Permanent molars without any adverse radiographic findings including thickening of the periodontal ligament space, radiolucency at the interradicular or periapical regions
- permanent molars without internal and external root resorption, or calcification in pulp tissue.
Who cannot join
- Medically compromised patients who have systemic disease.
- Uncooperative patients who refuse treatment.
- Permanent molars that were previously restored.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Bioceramic Putty Mineral Trioxide Aggregate Versus Mineral Trioxide Aggregate in Pulpotomy of Immature Permanent Molars: A Randomized Clinical Trial
The present study aims to evaluate the clinical and radiographic success of bioceramics putty MTA versus MTA in the pulpotomy of immature permanent molars
The main question it aims to answer is:
Will the biocermaics putty MTA have higher clinical and radiographic success rates than MTA in pulpotomy of immature permanent molars?
Read the detailed description
limited clinical trials have reported the clinical and radiographic outcomes after pulpotomy with premixed putty bioceramic MTA and conventional MTA in young permanent molars.
MTA has various drawbacks, such as difficulty in handling, long setting time, discoloration of the tooth, and its form as a powder/liquid which raise the responsibility for major material waste. To conquer these issues, bioceramic materials have been developed premixed putty bioceramic MTA is a ready-to-use material for immediate placement with zero waste, saving cost and chair time. Thus, the present study aims to evaluate bioceramic putty MTA's clinical and radiographic success versus MTA in pulpotomy of immature permanent molars.
- Conditions
- Pulpotomy, Deep Caries
- Being tested
- premixed Bio-ceramic MTA, Conventional MTA
- Keywords
- Immature permanent molars,, young permenent molars, pulpotomy, vital pulp therapy, deep caries, Putty MTA, bioceramic MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
premixed Bio-ceramic MTADrug
Also called well Root MTA
pulpotomy treatment will be done and the premixed bioceramic MTA will be applied in the pulp chamber
Conventional MTADrug
Also called Pro-root MTA
pulpotomy treatment will be done and powder and liquid MTA will be mixed and applied in the pulp chamber
| Study group | Role | What they receive |
|---|---|---|
| control Group | Active comparator | pulpotomy treatment for the young permanent teeth will be done using conventional powder and liquid Mineral Trioxide Aggregate followed by Glassionomer restoration and stainless steel crown Receives: Drug: Conventional MTA |
| Experimental | Experimental | pulpotomy treatment for the young permanent teeth will be done using premixed ready for use bioceramic MTA followed by Glassionomer restoration and stainless steel crown Receives: Drug: premixed Bio-ceramic MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Immediate Postoperative pain [ Time Frame: one week) post operative pain by Verbal analogue scale.It is a 10 cm long horizontal line with points labeled from 0 to 10 where (0) indicates no pain, (1-3) mild pain, (4-6) moderate pain, and (7-10) severe pain.
Measured: 24hrs, 1 week
Secondary outcomes (1)
Secondary outcome
The increase in root length, The root lengthening will be assessed in Mm through Digora software
Measured: 6,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpotomyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Abd El-Naby Hussien, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219824
- Sponsor's protocol ID
- 14422022599195
- Acronym
- MTA
- Status last verified
- Jul 2024
- First submitted
- 1 Jan 2024
- Last updated
- 23 Jul 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Bioceramic Putty Mineral Trioxide Aggregate Versus Mineral Trioxide Aggregate in Pulpotomy of Immature Permanent Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06219824
- Acronym / sponsor ID
- MTA / 14422022599195
- Conditions
- Pulpotomy, Deep Caries
- Keywords
- Immature permanent molars,, young permenent molars, pulpotomy, vital pulp therapy, deep caries, Putty MTA, bioceramic MTA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 23 Jan 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 present study aims to evaluate the clinical and radiographic success of bioceramics putty MTA versus MTA in the pulpotomy of immature permanent molars
The main question it aims to answer is:
Will the biocermaics putty MTA have higher clinical and radiographic success rates than MTA in pulpotomy of immature permanent molars?
Detailed description
limited clinical trials have reported the clinical and radiographic outcomes after pulpotomy with premixed putty bioceramic MTA and conventional MTA in young permanent molars.
MTA has various drawbacks, such as difficulty in handling, long setting time, discoloration of the tooth, and its form as a powder/liquid which raise the responsibility for major material waste. To conquer these issues, bioceramic materials have been developed premixed putty bioceramic MTA is a ready-to-use material for immediate placement with zero waste, saving cost and chair time. Thus, the present study aims to evaluate bioceramic putty MTA's clinical and radiographic success versus MTA in pulpotomy of immature permanent molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control Group | Active comparator | Drug: Conventional MTApulpotomy treatment for the young permanent teeth will be done using conventional powder and liquid Mineral Trioxide Aggregate followed by Glassionomer restoration and stainless steel crown |
| Experimental | Experimental | Drug: premixed Bio-ceramic MTApulpotomy treatment for the young permanent teeth will be done using premixed ready for use bioceramic MTA followed by Glassionomer restoration and stainless steel crown |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients aged from 6-8 years of both sexes have immature permanent molars
- with deep carious lesions indicated for pulpotomy.
- Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
- Permanent molars without any clinical sign of pulp necrosis including swelling, fistula, pain on percussion, and pathologic tooth mobility.
- Permanent molars without any adverse radiographic findings including thickening of the periodontal ligament space, radiolucency at the interradicular or periapical regions
Key exclusion criteria (3 listed)
- Medically compromised patients who have systemic disease.
- Uncooperative patients who refuse treatment.
- Permanent molars that were previously restored.
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 |
|---|---|---|
| premixed Bio-ceramic MTAAlso: well Root MTApulpotomy treatment will be done and the premixed bioceramic MTA will be applied in the pulp chamber | Drug | Experimental |
| Conventional MTAAlso: Pro-root MTApulpotomy treatment will be done and powder and liquid MTA will be mixed and applied in the pulp chamber | Drug | control Group |
Primary outcome
Primary Outcome
Time frame: 24hrs, 1 week
Immediate Postoperative pain [ Time Frame: one week) post operative pain by Verbal analogue scale.It is a 10 cm long horizontal line with points labeled from 0 to 10 where (0) indicates no pain, (1-3) mild pain, (4-6) moderate pain, and (7-10) severe pain.
1 secondary outcome
Secondary outcome
Time frame: 6,12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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Pomegranate Peel Extract for Primary Molar Pulpotomy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing premixed Bio-ceramic MTA and Conventional MTA in people with Pulpotomy and Deep Caries, 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 6 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 23 Jul 2024. 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.
What does this phase mean?
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?
Contact Marwa Ad Hussien, MSD (01222156972, marwa.hussien@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 24hrs, 1 week). 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 23 Jul 2024.