Pulp Disease, DentalNCT05102318
Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars
A study testing Direct Pulp Capping, Partial Pulpotomy and Pulpotomy in people with Pulp Disease, Dental, run by British University In Egypt at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy 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
- Pulp Disease, Dental
- What is being tested?
- Direct Pulp Capping, Partial Pulpotomy and Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 1 Sep 2022
- 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
- No clinical symptoms or history implying irreversible pulpitis such as spontaneous pain, or pain persisting after stimuli removal.
- Absence of periapical or interadicular radiolucencies, inflammatory root resorption, sinus tract or gingival abscess.
Who cannot join
- Children who are extremely uncooperative and difficult to manage.
- Children suffering from any physically or mentally disability that will complicate the treatment: Special Health Care needs (SHCN).
- Teeth of poor prognosis due to presence of an abscess or a sinus, mobility, advanced bone or root resorption or Non-Restorable teeth.
Trial locations and contacts
1 site in 1 country.
Nadia Metwalli, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Marwa Magdy, PhD, 00201007195996, marwa.magdy@bue.edu.eg
Nadia Metwalli, Professor, nadia.metwalli@bue.edu.eg
About this study
The aim of the present study is to evaluate Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.
Read the detailed description
Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database in Pediatric Dentistry department.
A total of 150 primary molars from healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain shams University.
Subjects will be assigned randomly into two different treatment groups as follows:
MTA Group (1):
- Group 1(A): MTA Direct Pulp Capping. (n=25)
- Group 1 (B): MTA Partial Pulpotomy. (n=25)
- Group 1 (C): MTA Complete Pulpotomy. (n=25)
BiodentineTM Group (2):
- Group 2(A): BiodentineTM Direct Pulp Capping. (n=25)
- Group 2 (B): BiodentineTM Partial Pulpotomy. (n=25)
- Group 2 (C): BiodentineTM Complete Pulpotomy. (n=25)
- Conditions
- Pulp Disease, Dental
- Being tested
- Direct Pulp Capping, Partial Pulpotomy, Pulpotomy
- Keywords
- Direct pulp capping, Partial Pulpotomy, and Pulpotomy
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Pulp CappingProcedure or surgery
Direct Pulp Capping
Partial PulpotomyProcedure or surgery
Partial Pulpotomy
PulpotomyProcedure or surgery
Pulpotomy
| Study group | Role | What they receive |
|---|---|---|
| Direct Pulp Capping with Biodentine | Experimental | Direct Pulp Capping with Biodentine Receives: Procedure: Direct Pulp Capping |
| Partial Pulpotomy with Biodentine | Experimental | Partial Pulpotomy with Biodentine Receives: Procedure: Partial Pulpotomy |
| Pulpotomy with Biodentine | Experimental | Pulpotomy with Biodentine Receives: Procedure: Pulpotomy |
| Direct Pulp Capping with MTA | Experimental | Direct Pulp Capping with MTA Receives: Procedure: Direct Pulp Capping |
| Partial Pulpotomy with MTA | Experimental | Partial Pulpotomy with MTA Receives: Procedure: Partial Pulpotomy |
| Pulpotomy with MTA | Experimental | Pulpotomy with MTA Receives: Procedure: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.
Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Apr 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Disease, DentalStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Marwa Magdy, British University In Egypt
- Investigators
- Noha Kabil, Professor, Study director, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102318
- Sponsor's protocol ID
- Ain Shams University
- Status last verified
- Jan 2022
- First submitted
- 20 Oct 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars
- ClinicalTrials.gov ID
- NCT05102318
- Acronym / sponsor ID
- Ain Shams University
- Conditions
- Pulp Disease, Dental
- Keywords
- Direct pulp capping, Partial Pulpotomy, and Pulpotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 1 Nov 2021 (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 aim of the present study is to evaluate Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.
Detailed description
Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database in Pediatric Dentistry department.
A total of 150 primary molars from healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain shams University.
Subjects will be assigned randomly into two different treatment groups as follows:
MTA Group (1):
- Group 1(A): MTA Direct Pulp Capping. (n=25)
- Group 1 (B): MTA Partial Pulpotomy. (n=25)
- Group 1 (C): MTA Complete Pulpotomy. (n=25)
BiodentineTM Group (2):
- Group 2(A): BiodentineTM Direct Pulp Capping. (n=25)
- Group 2 (B): BiodentineTM Partial Pulpotomy. (n=25)
- Group 2 (C): BiodentineTM Complete Pulpotomy. (n=25)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Direct Pulp Capping with Biodentine | Experimental | Procedure: Direct Pulp CappingDirect Pulp Capping with Biodentine |
| Partial Pulpotomy with Biodentine | Experimental | Procedure: Partial PulpotomyPartial Pulpotomy with Biodentine |
| Pulpotomy with Biodentine | Experimental | Procedure: PulpotomyPulpotomy with Biodentine |
| Direct Pulp Capping with MTA | Experimental | Procedure: Direct Pulp CappingDirect Pulp Capping with MTA |
| Partial Pulpotomy with MTA | Experimental | Procedure: Partial PulpotomyPartial Pulpotomy with MTA |
| Pulpotomy with MTA | Experimental | Procedure: PulpotomyPulpotomy with MTA |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- No clinical symptoms or history implying irreversible pulpitis such as spontaneous pain, or pain persisting after stimuli removal.
- Absence of periapical or interadicular radiolucencies, inflammatory root resorption, sinus tract or gingival abscess.
Key exclusion criteria (3 listed)
- Children who are extremely uncooperative and difficult to manage.
- Children suffering from any physically or mentally disability that will complicate the treatment: Special Health Care needs (SHCN).
- Teeth of poor prognosis due to presence of an abscess or a sinus, mobility, advanced bone or root resorption or Non-Restorable teeth.
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 |
|---|---|---|
| Direct Pulp CappingDirect Pulp Capping | Procedure or surgery | Direct Pulp Capping with Biodentine, Direct Pulp Capping with MTA |
| Partial PulpotomyPartial Pulpotomy | Procedure or surgery | Partial Pulpotomy with Biodentine, Partial Pulpotomy with MTA |
| PulpotomyPulpotomy | Procedure or surgery | Pulpotomy with Biodentine, Pulpotomy with MTA |
Primary outcome
Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.
Time frame: 18 months
Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- 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.
Nadia Metwalli, Professor contact
Noha Kabil, Professor study director
British University In Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Pulp Capping, Partial Pulpotomy and Pulpotomy in people with Pulp Disease, Dental, run by British University In Egypt 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 2 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 11 Feb 2022. 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.
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 Magdy, PhD (00201007195996, marwa.magdy@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars. (time frame: 18 months). 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 11 Feb 2022.