Pulp Exposure, DentalEarly Phase 1NCT05878158
Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars
A Early Phase 1 study testing Simvastatin in people with Pulp Exposure, Dental, run by Ahmad Elheeny at 1 site in Egypt.
Trial summary
the study will be done to evaluate the clinical and digital radiographic success of simvastatin versus MTA in pulpotomy of immature permanent molars Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Pulp Exposure, Dental
- What is being tested?
- Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Sep 2024
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Child
Who may be able to join
- Healthy children aged from 6 to 8 years
- Children with severe behavioral, or emotional disabilities, and medically compromised children will be excluded.
- Deep carious lesions of the first permanent immature molars with signs \& symptoms of reversible pulpitis will be included
- Normal radiographic findings and immature roots
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Minya, 61111
Ahmad Elheeny, PhD, EG135.30708112400351@nies-edu.org
About this study
Official title: Clinical and Digital Radiographic Evaluation of Simvastatin Versus MTA in Pulpotomy of Immature Permanent Vital Molars: A18 Month Randomized Controlled Trial
the study will be done to evaluate the clinical and digital radiographic success of simvastatin versus MTA in pulpotomy of immature permanent molars
Read the detailed description
the clinical and digital radiographic success of simvastatin versus MTA in pulpotomy of immature permanent molars for the following patients which include: Healthy children aged from 6 to 8 years who will be classified as Class I or II Children according to the American Society of Anaesthesiologists (ASA) will be included. Children with severe behavioral, or emotional disabilities, and medically compromised children will be excluded.
- Conditions
- Pulp Exposure, Dental
- Being tested
- Simvastatin
- Medical subject headings
- Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Mineral Trioxide Aggregate
pulpotomy of immature permanent teeth
| Study group | Role | What they receive |
|---|---|---|
| simvastatin | Active comparator | Drug The drug powder will be mixed with distilled water to form a paste applied in the pup chamber of immature permanent molars over the pulp stump Receives: Drug: Simvastatin |
| Mineral Trioxide Aggregate | Experimental | Dental material It is a regenrative endodontic material prepared as apoweder that mixed with distilled water to form a paste applied in the pup chamber of immature permanent molars over the pulp stump Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of pain
clinical assessment
Measured: one year
Secondary outcomes (1)
Dentin wall thickness
radiographic assessment
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 posted26 May 2023
- Study start1 Apr 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Exposure, 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmad Elheeny
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmad Elheeny, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878158
- Sponsor's protocol ID
- 300
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Digital Radiographic Evaluation of Simvastatin Versus MTA in Pulpotomy of Immature Permanent Vital Molars: A18 Month Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05878158
- Acronym / sponsor ID
- 300
- Conditions
- Pulp Exposure, Dental
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Ahmad ElheenyUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 26 May 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 study will be done to evaluate the clinical and digital radiographic success of simvastatin versus MTA in pulpotomy of immature permanent molars
Detailed description
the clinical and digital radiographic success of simvastatin versus MTA in pulpotomy of immature permanent molars for the following patients which include: Healthy children aged from 6 to 8 years who will be classified as Class I or II Children according to the American Society of Anaesthesiologists (ASA) will be included. Children with severe behavioral, or emotional disabilities, and medically compromised children will be excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| simvastatin | Active comparator | Drug: SimvastatinDrug The drug powder will be mixed with distilled water to form a paste applied in the pup chamber of immature permanent molars over the pulp stump |
| Mineral Trioxide Aggregate | Experimental | Drug: SimvastatinDental material It is a regenrative endodontic material prepared as apoweder that mixed with distilled water to form a paste applied in the pup chamber of immature permanent molars over the pulp stump |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children aged from 6 to 8 years
- Children with severe behavioral, or emotional disabilities, and medically compromised children will be excluded.
- Deep carious lesions of the first permanent immature molars with signs \& symptoms of reversible pulpitis will be included
- Normal radiographic findings and immature roots
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SimvastatinAlso: Mineral Trioxide Aggregatepulpotomy of immature permanent teeth | Drug | Mineral Trioxide Aggregate, simvastatin |
Primary outcome
Presence or absence of pain
Time frame: one year
clinical assessment
1 secondary outcome
Dentin wall thickness
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: Undecided
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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 Early Phase 1 study testing Simvastatin in people with Pulp Exposure, Dental, run by Ahmad Elheeny 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 4 inclusion and 0 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 26 May 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 mohamed aboalftooh, doctora (01092183998, Doctormasmanlover22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of pain (time frame: one year). 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 26 May 2023.