Indirect Pulp CappingPhase 3NCT05928858
Clinical And Radiographic Evaluation Of Premixed Bio-ceramic MTA In Indirect Pulp Capping Of Young Permanent Molars
A Phase 3 study testing Premixed Bio-ceramic MTA and Calcium hydroxide in people with Indirect Pulp Capping, run by Cairo University.
Trial summary
The present study aims to evaluate the clinical and radiographic success of premixed bio-ceramic MTA versus calcium hydroxide in indirect pulp capping of young permanent molars. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Indirect Pulp Capping
- What is being tested?
- Premixed Bio-ceramic MTA and Calcium hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Sep 2024
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who have young permanent molars with deep carious lesions.
- Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
- Permanent molars with no clinical or radiographic signs of pulp necrosis including swelling, fistula, pain on percussion,pathologic tooth mobility, thickening of the periodontal ligament space, radiolucency at the periapical area.
Who cannot join
- Medically compromised patients who have systemic disease.
- Uncooperative patients who refuse treatment
- Permanent molars that were previously restored
- Children whose parents or caregivers refuse to participate in the study.
Trial locations and contacts
No sites are listed yet.
Sara Ah Mahmoud, Professor contact
About this study
Official title: Clinical And Radiographic Evaluation Of Premixed Bio-ceramic Mineral Trioxide Aggregate Versus Calcium Hydroxide In Indirect Pulp Capping Of Young Permanent Molars: A Randomized Controlled Trial
The present study aims to evaluate the clinical and radiographic success of premixed bio-ceramic MTA versus calcium hydroxide in indirect pulp capping of young permanent molars.
Read the detailed description
Researchers are still in search of an ideal material for pulp capping, and they evaluated numerous dental materials. For many decades, calcium hydroxide has been the 'gold standard' material for maintaining pulp vitality. Both clinically and histologically, it has been found to produce satisfactory results in indirect and direct pulp capping because it can stimulate the formation of tertiary dentine by the pulp and it has antimicrobial properties.
Due to the drawbacks of calcium hydroxide, several materials have been developed, such as NeoPUTTY which is premixed bio-ceramic Mineral Trioxide Aggregate (MTA) that triggers hydroxyapatite. Its firm, non-tacky consistency, wash-out resistance, and bioactivity make it a pediatric dentists' preferred material for every pulp need. It also delivers ready-to-use material for immediate placement with zero waste, saving cost and chair time.
- Conditions
- Indirect Pulp Capping
- Being tested
- Premixed Bio-ceramic MTA, Calcium hydroxide
- Keywords
- neoputty, premixed bioceramic MTA, young permanent teeth, calcium hydroxide
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 Neoputty
Partial caries removal will be carried out then Premixed Bio-ceramic MTA will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration
Calcium hydroxideDrug
Also called Dycal, Hydcal
Partial caries removal will be carried out then calcium hydroxide will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration
| Study group | Role | What they receive |
|---|---|---|
| Premixed Bio-ceramic MTA | Experimental | Partial caries removal will be carried out then Premixed Bio-ceramic MTA will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration Receives: Drug: Premixed Bio-ceramic MTA |
| Calcium hydroxide | Active comparator | Partial caries removal will be carried out then calcium hydroxide will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration Receives: Drug: Calcium hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Postoperative pain
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: one week
Secondary outcomes (3)
The thickness of newly formed dentin
The thickness of newly formed dentin will be assessed in Mm through Digora software
Measured: 3,6,9,12 month
Soft tissue pathology
Swelling, sinus tract, fistula, mobility and pain on percussion will be assessed by clinical examination either present or not (binary)
Measured: 3,6,9,12 month
Radiographic changes
Radiolucency at the periapical or furcation area and Internal or external root resorption will be assessed through a digital periapical intraoral radiograph either present or not ( Binary)
Measured: 3,6,9,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study startSep 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indirect Pulp CappingStudies 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
- Model description
- Randomized controlled trial
- 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, Aya Adel Abd El-Hafez Osman Hamza, Cairo University
- Investigators
- Aya Ad Hamza, Phd, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928858
- Sponsor's protocol ID
- 14422022585603
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be shared with citation to the investigator but not personal data of the patients to protect confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Radiographic Evaluation Of Premixed Bio-ceramic Mineral Trioxide Aggregate Versus Calcium Hydroxide In Indirect Pulp Capping Of Young Permanent Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05928858
- Acronym / sponsor ID
- 14422022585603
- Conditions
- Indirect Pulp Capping
- Keywords
- neoputty, premixed bioceramic MTA, young permanent teeth, calcium hydroxide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 3 Jul 2023 (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 premixed bio-ceramic MTA versus calcium hydroxide in indirect pulp capping of young permanent molars.
Detailed description
Researchers are still in search of an ideal material for pulp capping, and they evaluated numerous dental materials. For many decades, calcium hydroxide has been the 'gold standard' material for maintaining pulp vitality. Both clinically and histologically, it has been found to produce satisfactory results in indirect and direct pulp capping because it can stimulate the formation of tertiary dentine by the pulp and it has antimicrobial properties.
Due to the drawbacks of calcium hydroxide, several materials have been developed, such as NeoPUTTY which is premixed bio-ceramic Mineral Trioxide Aggregate (MTA) that triggers hydroxyapatite. Its firm, non-tacky consistency, wash-out resistance, and bioactivity make it a pediatric dentists' preferred material for every pulp need. It also delivers ready-to-use material for immediate placement with zero waste, saving cost and chair time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Premixed Bio-ceramic MTA | Experimental | Drug: Premixed Bio-ceramic MTAPartial caries removal will be carried out then Premixed Bio-ceramic MTA will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration |
| Calcium hydroxide | Active comparator | Drug: Calcium hydroxidePartial caries removal will be carried out then calcium hydroxide will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients who have young permanent molars with deep carious lesions.
- Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
- Permanent molars with no clinical or radiographic signs of pulp necrosis including swelling, fistula, pain on percussion,pathologic tooth mobility, thickening of the periodontal ligament space, radiolucency at the periapical area.
Key exclusion criteria (4 listed)
- Medically compromised patients who have systemic disease.
- Uncooperative patients who refuse treatment
- Permanent molars that were previously restored
- Children whose parents or caregivers refuse to participate in the study.
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: NeoputtyPartial caries removal will be carried out then Premixed Bio-ceramic MTA will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration | Drug | Premixed Bio-ceramic MTA |
| Calcium hydroxideAlso: Dycal, HydcalPartial caries removal will be carried out then calcium hydroxide will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration | Drug | Calcium hydroxide |
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.
3 secondary outcomes
The thickness of newly formed dentin
Time frame: 3,6,9,12 month
Soft tissue pathology
Time frame: 3,6,9,12 month
Radiographic changes
Time frame: 3,6,9,12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No. IPD can be shared with citation to the investigator but not personal data of the patients to protect confidentiality.
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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.
Sara Ah Mahmoud, Professor contact
Aya Ad Hamza, Phd principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Premixed Bio-ceramic MTA and Calcium hydroxide in people with Indirect Pulp Capping, 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 3 inclusion and 4 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 1 Aug 2023. 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 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 Aya Ad Hamza, Phd (01062315566, aya.adel@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Postoperative pain (time frame: one 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 1 Aug 2023.