PulpotomyNCT05747300
Wellroot PT Versus MTA in Pulpotomy of Primary Molars
A study testing Premixed bioceramic paste wellroot PT in people with Pulpotomy, run by Cairo University.
Trial summary
compare the clinical and radiographic success of mineral trioxide aggregate (MTA) versus premixed bioceramic paste (Wellroot PT) as pulpotomy medicaments in primary molars. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy
- What is being tested?
- Premixed bioceramic paste wellroot PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2024
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Children aged between 4 years and 7 years.
- Mandibular second primary molar with deep caries involving pulp.
- No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule.
- Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
- Radiographic criteria:
- No sign of radiolucency in periapical or furcation area.
- No widening of PDL space or loss of lamina dura continuity.
- No evidence of internal/external pathologic root resorption.
Who cannot join
- • Uncooperative children.
- Children with systemic disease.
- Lack of informed consent by the child patient's parent.
- Unable to attend follow-up visits.
- Refusal of participation.
About this study
Official title: Clinical and Radiographic Evaluation of Premixed Bioceramic Paste (Wellroot PT) Versus Mineral Trioxide Aggregate (MTA) in Pulpotomy of Primary Molars: A Randomized Clinical Pilot Study
compare the clinical and radiographic success of mineral trioxide aggregate (MTA) versus premixed bioceramic paste (Wellroot PT) as pulpotomy medicaments in primary molars.
Read the detailed description
Preservation of primary dentition decreases the risk of developing any occlusal abnormalities caused by premature loss of primary teeth, which are considered natural space maintainers for the successor permanent teeth, therefore vital pulp therapy is of a big concern in the research field in pediatric dentistry .
One of the most commonly used regenerative materials in pulpotomies is Mineral Trioxide Aggregate (MTA) which showed a high success rate clinically and radiographically when compared to other materials due to its biocompatibility, antibacterial properties and excellent sealing ability . However it has some drawbacks such as difficult manipulation and handling because it is supplied in powder and liquid form which need mixing. Mixing is operator dependant and may be not uniform if handled wrongly, technique sensitive, potential discoloration, and long setting time.
Premixed bioceramics Well-Root™ PT (Vericom, Gangwon-Do, Korea) have been introduced into the market and present with desirable properties as a pulp capping agent. Owing to good handling characteristics, biocompatibility, odontogenic property and antibacterial action, the premixed bioceramic materials are recommended for procedures such as pulp capping, pulpotomy, perforation repair, root-end filling, and obturation.
- Conditions
- Pulpotomy
- Being tested
- Premixed bioceramic paste wellroot PT
- Keywords
- Pulpotomy wellroot PT bioceramic paste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premixed bioceramic paste wellroot PTOther
Also called Wellroot PT
Vital pulpotomy primary Molars using premixed bioceramic paste wellrootPT
| Study group | Role | What they receive |
|---|---|---|
| MTA pulpotomy | Active comparator | Vital pulpotomy primary Molars using MTA Receives: Other: Premixed bioceramic paste wellroot PT |
| Wellroot PT pulpotomy | Experimental | Vital pulpotomy primary Molars using premixed bioceramic paste wellroot PT Receives: Other: Premixed bioceramic paste wellroot PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Binary (present/absent) Verbal question to patient/ parent
Measured: 1 year
Soft tissue pathology
Binary (present/absent) Visual clinical examination
Measured: 1 year
Pain to percussion
Binary (present/absent) Percussion test by the back of the dental mirror
Measured: 1 year
Pathologic mobility
Binary (present/absent) Mobility test (pressure using the end of two dental mirrors)
Measured: 1 year
Secondary outcomes (1)
Absence of furcation or periapical radiolucency Absence of external or internal root resorption
Binary (present/absent) Intraoral digital periapical X-ray
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 posted28 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionDec 2024 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Gamal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747300
- Sponsor's protocol ID
- Experimental
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Premixed Bioceramic Paste (Wellroot PT) Versus Mineral Trioxide Aggregate (MTA) in Pulpotomy of Primary Molars: A Randomized Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT05747300
- Acronym / sponsor ID
- Experimental
- Conditions
- Pulpotomy
- Keywords
- Pulpotomy wellroot PT bioceramic paste
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Feb 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.
compare the clinical and radiographic success of mineral trioxide aggregate (MTA) versus premixed bioceramic paste (Wellroot PT) as pulpotomy medicaments in primary molars.
Detailed description
Preservation of primary dentition decreases the risk of developing any occlusal abnormalities caused by premature loss of primary teeth, which are considered natural space maintainers for the successor permanent teeth, therefore vital pulp therapy is of a big concern in the research field in pediatric dentistry .
One of the most commonly used regenerative materials in pulpotomies is Mineral Trioxide Aggregate (MTA) which showed a high success rate clinically and radiographically when compared to other materials due to its biocompatibility, antibacterial properties and excellent sealing ability . However it has some drawbacks such as difficult manipulation and handling because it is supplied in powder and liquid form which need mixing. Mixing is operator dependant and may be not uniform if handled wrongly, technique sensitive, potential discoloration, and long setting time.
Premixed bioceramics Well-Root™ PT (Vericom, Gangwon-Do, Korea) have been introduced into the market and present with desirable properties as a pulp capping agent. Owing to good handling characteristics, biocompatibility, odontogenic property and antibacterial action, the premixed bioceramic materials are recommended for procedures such as pulp capping, pulpotomy, perforation repair, root-end filling, and obturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTA pulpotomy | Active comparator | Other: Premixed bioceramic paste wellroot PTVital pulpotomy primary Molars using MTA |
| Wellroot PT pulpotomy | Experimental | Other: Premixed bioceramic paste wellroot PTVital pulpotomy primary Molars using premixed bioceramic paste wellroot PT |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- • Children aged between 4 years and 7 years.
- No sign of radiolucency in periapical or furcation area.
- No widening of PDL space or loss of lamina dura continuity.
- No evidence of internal/external pathologic root resorption.
Key exclusion criteria (5 listed)
- • Uncooperative children.
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 bioceramic paste wellroot PTAlso: Wellroot PTVital pulpotomy primary Molars using premixed bioceramic paste wellrootPT | Other | MTA pulpotomy, Wellroot PT pulpotomy |
Primary outcome
Post-operative pain
Time frame: 1 year
Binary (present/absent) Verbal question to patient/ parent
Soft tissue pathology
Time frame: 1 year
Binary (present/absent) Visual clinical examination
Pain to percussion
Time frame: 1 year
Binary (present/absent) Percussion test by the back of the dental mirror
Pathologic mobility
Time frame: 1 year
Binary (present/absent) Mobility test (pressure using the end of two dental mirrors)
1 secondary outcome
Absence of furcation or periapical radiolucency Absence of external or internal root resorption
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
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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 study testing Premixed bioceramic paste wellroot PT in people with Pulpotomy, 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 8 inclusion and 5 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 28 Feb 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.
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?
Post-operative pain (time frame: 1 year). The study lists 4 primary outcomes in all. 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 28 Feb 2023.