Indirect Pulp CappingNCT05597553
Evaluation of Premixed Verses Powder/Liquid Bioceramic MTA in Indirect Pulp Capping.
A study testing Premixed MTA and Powder/liquid MTA in people with Indirect Pulp Capping, run by Cairo University.
Trial summary
Evaluate Clinical and Radiographic Evaluation of Premixed verses Powder / Liquid Bioceramic Mineral Trioxide Aggregate in Indirect Pulp Capping of Immature Permanent Mandibular Molars Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Indirect Pulp Capping
- What is being tested?
- Premixed MTA and Powder/liquid MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Dec 2023
- Phase
- Interventional
- 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
- Medically fit and cooperative children.
- Pediatric patients aged 6-8 years.
- Deep caries with reversible pulpits in immature first permanent mandibular molars indicated for indirect pulp capping.
- Absence of clinical signs and symptoms of pulpal exposure.
- Absence of radiographic signs and symptoms of pulp degeneration.
- Positive parental informed consent.
Who cannot join
- Clinical symptoms of irreversible pulpitis requiring endodontic treatment.
- Clinical symptoms of pulp exposure.
- The presence of fistulas or swelling.
Trial locations and contacts
No sites are listed yet.
Rania Nasr, Professor contact
About this study
Official title: Clinical and Radiographic Evaluation of Premixed Verses Powder / Liquid Bioceramic Mineral Trioxide Aggregate in Indirect Pulp Capping of Immature Permanent Mandibular Molars: A Randomized Clinical Trial
Evaluate Clinical and Radiographic Evaluation of Premixed verses Powder / Liquid Bioceramic Mineral Trioxide Aggregate in Indirect Pulp Capping of Immature Permanent Mandibular Molars
Read the detailed description
Mineral trioxide aggregate (MTA) is a bioactive, biocompatible, antibacterial material with good stability, and excellent sealing ability that has been used as a dressing material in pulp capping procedures in permanent teeth.
Although it has good properties, MTA has many limitations, including long setting time, handling property and tooth discoloration making the use of this material challenging for many clinicians.
Researchers and manufacturers have made progress in overcoming these problems in recent years, new and improved products are becoming available such as the premixed bioceramic putty.
The premixed bioceramics putty are ready to use materials, fast setting, with superior handling properties and hydrophilic in nature that necessitate moisture from the adjacent tissues to set. They have advantage of insensitive to moisture and blood contamination with less technique sensitive. Upon setting, they become hard and expand slightly providing with superior long-term seal.
Premixed Bio-ceramics (BC) are highly alkaline materials (pH = 12.7), they release calcium and have antibacterial activity. Their biocompatibility is higher than that of MTA, this is attributed to the absence of heavy metals from the premixed BC components.
The premixed bio-ceramic putty (Well-Root™ PT) has been developed for the management of pulp capping procedures with the advantage of uniform homogenous consistency and lack of waste. It is radiopaque material based on a calcium aluminosilicate composition.
It has excellent biological \& physical properties and does not shrink during setting. Well-Root™ PT does not create an inflammatory response and promotes mineralization.
- Conditions
- Indirect Pulp Capping
- Being tested
- Premixed MTA, Powder/liquid MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premixed MTAOther
Also called MTA Putty
The premixed Bio-ceramic putty during setting become hard and expand slightly providing a superior long-term seal
Powder/liquid MTAOther
Mineral trioxide aggregate (MTA) is a silicate material that is said to aid in faster bridge formation with fewer tunnel defects, less pulpal inflammation, and the maintenance of pulpal integrity. It is widely used in pediatric dentistry due to its excellent sealing properties.
| Study group | Role | What they receive |
|---|---|---|
| Premixed MTA | Experimental | The premixed bioceramics putty are ready to use materials, fast setting, with superior handling properties and hydrophilic in nature that necessitate moisture from the adjacent tissues to set. They have advantage of insensitive to moisture and blood contamination with less technique sensitive. Receives: Other: Premixed MTA; Other: Powder/liquid MTA |
| Powder/liquid MTA | Active comparator | Mineral trioxide aggregate (MTA) is a bioactive, biocompatible, antibacterial material with good stability, and excellent sealing ability that has been used as a dressing material in pulp capping procedures in permanent teeth, although it has good properties, it has many limitations, including long setting time, handling property and tooth discoloration making the use of this material challenging for many clinicians. Receives: Other: Premixed MTA; Other: Powder/liquid MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Clinical examination by(Visual Analogue Scale) System (0 - Mild - Moderate - Severe)
Measured: 12months
Secondary outcomes (2)
Pulp vitality
Evaluate of pulp vitality by Electrical pulp test 9Normal response, Exaggerated brief Exaggerated prolong, Negative)
Measured: 12months
Absence of furcal radiolucency or root resorption
Evaluate Periapical Intraoral Digital Radiography if present or absent
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mineral trioxide aggregate (MTA) is a bioactive, biocompatible, antibacterial material with good stability and excellent sealing ability that has been used as a dressing material in pulp capping procedures in permanent teeth
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aisha Magdy Khairy Abozaid, Cairo University
- Investigators
- Mai Mohamed, Lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597553
- Sponsor's protocol ID
- PM Mta verses P/L
- Status last verified
- Dec 2022
- First submitted
- 19 Oct 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Torabinejad M, Parirokh M, Dummer PMH. Mineral trioxide aggregate and other bioactive endodontic cements: an updated overview - part II: other clinical applications and complications. Int Endod J. 2018 Mar;51(3):284-317. doi: 10.1111/iej.12843. Epub 2017 Oct 11.
PubMed 28846134Abdelmotelb MA, Gomaa YF, Khattab NMA, Elheeny AAH. Premixed bioceramics versus mineral trioxide aggregate in furcal perforation repair of primary molars: in vitro and in vivo study. Clin Oral Investig. 2021 Aug;25(8):4915-4925. doi: 10.1007/s00784-021-03800-3. Epub 2021 Jan 22.
PubMed 33483869Motwani N, Ikhar A, Nikhade P, Chandak M, Rathi S, Dugar M, Rajnekar R. Premixed bioceramics: A novel pulp capping agent. J Conserv Dent. 2021 Mar-Apr;24(2):124-129. doi: 10.4103/JCD.JCD_202_20. Epub 2021 Oct 9.
PubMed 34759576Khairy AM, Nasr RAT, Ali MM. Clinical and radiographic evaluation of premixed versus powder/liquid bioceramic mineral trioxide aggregate in indirect pulp capping of immature permanent mandibular molars: a randomized clinical trial. BMC Oral Health. 2026 Feb 20;26(1):394. doi: 10.1186/s12903-026-07811-y.
PubMed 41721378
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Premixed Verses Powder / Liquid Bioceramic Mineral Trioxide Aggregate in Indirect Pulp Capping of Immature Permanent Mandibular Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05597553
- Acronym / sponsor ID
- PM Mta verses P/L
- Conditions
- Indirect Pulp Capping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 Oct 2022 (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.
Evaluate Clinical and Radiographic Evaluation of Premixed verses Powder / Liquid Bioceramic Mineral Trioxide Aggregate in Indirect Pulp Capping of Immature Permanent Mandibular Molars
Detailed description
Mineral trioxide aggregate (MTA) is a bioactive, biocompatible, antibacterial material with good stability, and excellent sealing ability that has been used as a dressing material in pulp capping procedures in permanent teeth.
Although it has good properties, MTA has many limitations, including long setting time, handling property and tooth discoloration making the use of this material challenging for many clinicians.
Researchers and manufacturers have made progress in overcoming these problems in recent years, new and improved products are becoming available such as the premixed bioceramic putty.
The premixed bioceramics putty are ready to use materials, fast setting, with superior handling properties and hydrophilic in nature that necessitate moisture from the adjacent tissues to set. They have advantage of insensitive to moisture and blood contamination with less technique sensitive. Upon setting, they become hard and expand slightly providing with superior long-term seal.
Premixed Bio-ceramics (BC) are highly alkaline materials (pH = 12.7), they release calcium and have antibacterial activity. Their biocompatibility is higher than that of MTA, this is attributed to the absence of heavy metals from the premixed BC components.
The premixed bio-ceramic putty (Well-Root™ PT) has been developed for the management of pulp capping procedures with the advantage of uniform homogenous consistency and lack of waste. It is radiopaque material based on a calcium aluminosilicate composition.
It has excellent biological \& physical properties and does not shrink during setting. Well-Root™ PT does not create an inflammatory response and promotes mineralization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Mineral trioxide aggregate (MTA) is a bioactive, biocompatible, antibacterial material with good stability and excellent sealing ability that has been used as a dressing material in pulp capping procedures in permanent teeth
| Arm | Type | Receives |
|---|---|---|
| Premixed MTA | Experimental | Other: Premixed MTA, Other: Powder/liquid MTAThe premixed bioceramics putty are ready to use materials, fast setting, with superior handling properties and hydrophilic in nature that necessitate moisture from the adjacent tissues to set. They have advantage of insensitive to moisture and blood contamination with less technique sensitive. |
| Powder/liquid MTA | Active comparator | Other: Premixed MTA, Other: Powder/liquid MTAMineral trioxide aggregate (MTA) is a bioactive, biocompatible, antibacterial material with good stability, and excellent sealing ability that has been used as a dressing material in pulp capping procedures in permanent teeth, although it has good properties, it has many limitations, including long setting time, handling property and tooth discoloration making the use of this material challenging for many clinicians. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Medically fit and cooperative children.
- Pediatric patients aged 6-8 years.
- Deep caries with reversible pulpits in immature first permanent mandibular molars indicated for indirect pulp capping.
- Absence of clinical signs and symptoms of pulpal exposure.
- Absence of radiographic signs and symptoms of pulp degeneration.
Key exclusion criteria (3 listed)
- Clinical symptoms of irreversible pulpitis requiring endodontic treatment.
- Clinical symptoms of pulp exposure.
- The presence of fistulas or swelling.
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 MTAAlso: MTA PuttyThe premixed Bio-ceramic putty during setting become hard and expand slightly providing a superior long-term seal | Other | Powder/liquid MTA, Premixed MTA |
| Powder/liquid MTAMineral trioxide aggregate (MTA) is a silicate material that is said to aid in faster bridge formation with fewer tunnel defects, less pulpal inflammation, and the maintenance of pulpal integrity. It is widely used in pediatric dentistry due to its excellent sealing properties. | Other | Powder/liquid MTA, Premixed MTA |
Primary outcome
Post operative pain
Time frame: 12months
Clinical examination by(Visual Analogue Scale) System (0 - Mild - Moderate - Severe)
2 secondary outcomes
Pulp vitality
Time frame: 12months
Absence of furcal radiolucency or root resorption
Time frame: 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Results publication: PubMed 28846134Torabinejad M, Parirokh M, Dummer PMH. Mineral trioxide aggregate and other bioactive endodontic cements: an updated overview - part II: other clinical applications and complications. Int Endod J. 2018 Mar;51(3):284-317. doi: 10.1111/iej.12843. Epub 2017 Oct 11.
- Results publication: PubMed 33483869Abdelmotelb MA, Gomaa YF, Khattab NMA, Elheeny AAH. Premixed bioceramics versus mineral trioxide aggregate in furcal perforation repair of primary molars: in vitro and in vivo study. Clin Oral Investig. 2021 Aug;25(8):4915-4925. doi: 10.1007/s00784-021-03800-3. Epub 2021 Jan 22.
- Results publication: PubMed 34759576Motwani N, Ikhar A, Nikhade P, Chandak M, Rathi S, Dugar M, Rajnekar R. Premixed bioceramics: A novel pulp capping agent. J Conserv Dent. 2021 Mar-Apr;24(2):124-129. doi: 10.4103/JCD.JCD_202_20. Epub 2021 Oct 9.
- Derived from this study: PubMed 41721378Khairy AM, Nasr RAT, Ali MM. Clinical and radiographic evaluation of premixed versus powder/liquid bioceramic mineral trioxide aggregate in indirect pulp capping of immature permanent mandibular molars: a randomized clinical trial. BMC Oral Health. 2026 Feb 20;26(1):394. doi: 10.1186/s12903-026-07811-y.
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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.
Rania Nasr, Professor contact
Mai Mohamed, Lecturer study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Premixed MTA and Powder/liquid MTA 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 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 5 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aisha MK Magdy, BDS (01060259375, aisha.abozaid@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05597553, which also lists 4 linked publications.
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 5 Dec 2022.