Irreversible PulpitisPhase 1NCT06925490
Comparison of 3Mixtatin Pulpotomy and Metapex Pulpectomy in Primary Molars With Irreversible Pulpitis
A Phase 1 study testing Metapex and 3Mixtatin in people with Irreversible Pulpitis and Primary Teeth, run by Cairo University.
Trial summary
The present study aims to evaluate the clinical and radiographic success of pulpotomy using 3Mixtatin versus pulpectomy using Metapex in primary molars with irreversible pulpitis in children aged 4 to 9 years. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis, Primary Teeth, Pulp Disease, Dental
- What is being tested?
- Metapex and 3Mixtatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged from 4 to 9 years with vital primary molars showing signs of irreversible pulpitis.
- Children with spontaneous pain lasting a few seconds to several hours.
- Pain is intensified by thermal stimulus and persists after its removal.
- Pulp hemorrhage after performing access cavity and deroofing of pulp chamber showing reddish pink healthy pulp tissue.
- Radicular pulp health is verified by achieving hemostasis within eight minutes of compression using a cotton pellet with 5% sodium hypochlorite.
- Absence of peri-apical or inter-radicular radiolucency, widening of periodontal ligament space, internal or external root resorption.
Who cannot join
- Unrestorable primary molars.
- Primary molars with uncontrolled pulp hemorrhage or pulp necrosis.
- Medically compromised patients who have systemic disease.
- Uncooperative children who refuse treatment.
- Children whose parents are unwilling to place stainless steel crowns.
- Children whose parents or caregivers refuse to participate in the study or are unable to attend follow-up visits.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marwa Aly Fouad, Associate Professor contact
About this study
Official title: Clinical and Radiographic Evaluation of Pulpotomy Using 3Mixtatin Versus Pulpectomy Using Metapex in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis in Children Aged 4 to 9 Years: A Randomized Clinical Trial.
The present study aims to evaluate the clinical and radiographic success of pulpotomy using 3Mixtatin versus pulpectomy using Metapex in primary molars with irreversible pulpitis in children aged 4 to 9 years.
Read the detailed description
Primary teeth play an essential role in esthetics, phonatics, and mastication, that's why they should be preserved as the best space maintainers until their proper exfoliation time. Various pulp therapies were suggested based on the extent of carries, including vital pulp therapy (direct pulp capping, pulpotomy) and non-vital pulp therapy (pulpectomy). Current guidelines from the American Academy of Pediatric Dentistry (AAPD) and the British Society of Paediatric Dentistry (BSPD) recommend pulpectomy as the gold standard treatment for vital primary molars diagnosed with irreversible pulpitis. Pulpectomy is a non-vital treatment procedure where the entire pulp tissue is extirpated and the root canals debrided and shaped to receive a resorbable material to fill the canal space in the affected primary tooth.
In recent years, a paradigm shift has emerged towards performing pulpotomy, a more conservative approach that involves partial removal of the pulp tissue, furthermore, a previous histological study of teeth with irreversible pulpitis showed that inflammation and microbial invasion are confined to the coronal pulp, sparing the radicular pulp. This finding concurred that pulpotomy could represent a viable treatment option for teeth diagnosed with irreversible pulpitis, as it preserves tooth structure, enhances healing potential in the remaining pulp promoting long-term clinical and radiographic success.
Recently, the concept of a newer economical material "3Mixtatin" has come into research and has been studied for its use in direct pulp capping, inflammatory root resorption, and pulpotomy in primary teeth. The material is a combination of 3Mix (cefixime, metronidazole, and ciprofloxacin) and a statin (Simvastatin).
3Mixtatin, incorporates Simvastatin, an antihyperlipidemic drug, into the triple antibiotic paste, Simvastatin was used as an anti inflammatory and bioinductive agent, whereas 3Mix served as an antibacterial agent.
Statin components are emerging materials in regenerative dentistry. Evidence from both experimental and clinical studies supports the notion of 'pleiotropic' effects of statins, they improve osteoblasts function and suppress function of osteoclast leading to enhanced bone formation. Therefore, they might improve odontoblastic function resulting in improved dentin formation. Statins are also thought to induce angiogenesis and increase neuronal cell. Consequently, they play a role in pulp regeneration along with dentin regeneration. In addition, sufficient evidence exists in support of the potent anti-inflammatory properties of statins, they reduce circulating C-reactive protein (CRP) and pro-inflammatory cytokines, lowering the amount of interleukin-6 and interleukin-8 in inflamed pulpal tissues.
Owing to limited availability of data in researches and in order to reach conclusive results on whether pulpotomy can be offered as an alternate treatment to pulpectomy in vital primary molars diagnosed with irreversible pulpitis, our study aims to evaluate clinical and radiographic success of of pulpotomy using 3Mixtatin versus pulpectomy using Metapex with vital primary molars diagnosed with symptomatic irreversible pulpitis in children aged 4 to 9 years.
- Conditions
- Irreversible Pulpitis, Primary Teeth, Pulp Disease, Dental
- Being tested
- Metapex, 3Mixtatin
- Keywords
- 3Mixtatin, irreversible pulpitis, metapex, pulpectomy, 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.
MetapexDrug
Pulpectomy using Metapex
3MixtatinDrug
pulpotomy treatment when applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin
| Study group | Role | What they receive |
|---|---|---|
| metapex pulpectomy | Active comparator | Single-visit pulpectomy using Metapex, . Calcium hydroxide-iodoform mixture (Metapex) is an ideal pulpal filling material for primary teeth. Receives: Drug: Metapex |
| 3Mixtatin Pulpotomy | Experimental | pulpotomy with 3 mixtatin (triple antibiotic paste of (Metronidazole, cefixime, and Ciprofloxacin mixed with simvastatin ) applied in the vital pulp therapy Receives: Drug: 3Mixtatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
- Pain to percussion will be assessed by applying a light-tapping force to the relevant tooth using the blunt end of the dental probe. Tapping will be applied as gently as possible from a 1 cm distance, either present or absent.
- Swelling will be assessed through clinical examination, either present or absent.
- The sinus tract or fistula will be assessed through clinical examination, either present or absent.
- The mobility of teeth will be assessed by applying pressure to the ends of two metal instruments, either present or absent.
- The principal investigator and the co-supervisor will undertake this clinical assessment on every recall visit during the 3, 6, 9, and 12 months follow-up period.
Measured: 3, 6, 9, and 12 months follow-up period
Secondary outcomes (2)
Radiographic Success
- Radiolucency at the furcation or periapical area, internal or external root resorption, will be examined (present or not) through digital periapical radiographs.
- The radiographic assessments will be performed as baseline data at the first visit following the procedure completion and at 6 and 12 months after the baseline
- The Two blind assessors will independently evaluate the radiographic outcomes.
Measured: 6 and 12 months
Post operative pain
After the completion of treatment, post-operative pain will be assessed using the Visual analog scale. This scale comprises six faces, with numbers ranging from 0 to 10 and word descriptions. During follow-up visits, the patients are asked to point to the face that best represents their feelings.
Measured: 1 week, 3, 6, 9, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study startJun 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Mohamed Mosaad Hussien, Cairo University
- Investigators
- Osama Ibrahim El Shahawy, Professor, Study director, Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo UniversityMarwa Aly Fouad, Associate professor, Study chair, Associate Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925490
- Sponsor's protocol ID
- 3Mixtatin and Metapex pulpitis
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 27 Apr 2025
- 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 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Pulpotomy Using 3Mixtatin Versus Pulpectomy Using Metapex in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis in Children Aged 4 to 9 Years: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06925490
- Acronym / sponsor ID
- 3Mixtatin and Metapex pulpitis
- Conditions
- Irreversible Pulpitis, Primary Teeth, Pulp Disease, Dental
- Keywords
- 3Mixtatin, irreversible pulpitis, metapex, pulpectomy, pulpotomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Apr 2025 (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 pulpotomy using 3Mixtatin versus pulpectomy using Metapex in primary molars with irreversible pulpitis in children aged 4 to 9 years.
Detailed description
Primary teeth play an essential role in esthetics, phonatics, and mastication, that's why they should be preserved as the best space maintainers until their proper exfoliation time. Various pulp therapies were suggested based on the extent of carries, including vital pulp therapy (direct pulp capping, pulpotomy) and non-vital pulp therapy (pulpectomy). Current guidelines from the American Academy of Pediatric Dentistry (AAPD) and the British Society of Paediatric Dentistry (BSPD) recommend pulpectomy as the gold standard treatment for vital primary molars diagnosed with irreversible pulpitis. Pulpectomy is a non-vital treatment procedure where the entire pulp tissue is extirpated and the root canals debrided and shaped to receive a resorbable material to fill the canal space in the affected primary tooth.
In recent years, a paradigm shift has emerged towards performing pulpotomy, a more conservative approach that involves partial removal of the pulp tissue, furthermore, a previous histological study of teeth with irreversible pulpitis showed that inflammation and microbial invasion are confined to the coronal pulp, sparing the radicular pulp. This finding concurred that pulpotomy could represent a viable treatment option for teeth diagnosed with irreversible pulpitis, as it preserves tooth structure, enhances healing potential in the remaining pulp promoting long-term clinical and radiographic success.
Recently, the concept of a newer economical material "3Mixtatin" has come into research and has been studied for its use in direct pulp capping, inflammatory root resorption, and pulpotomy in primary teeth. The material is a combination of 3Mix (cefixime, metronidazole, and ciprofloxacin) and a statin (Simvastatin).
3Mixtatin, incorporates Simvastatin, an antihyperlipidemic drug, into the triple antibiotic paste, Simvastatin was used as an anti inflammatory and bioinductive agent, whereas 3Mix served as an antibacterial agent.
Statin components are emerging materials in regenerative dentistry. Evidence from both experimental and clinical studies supports the notion of 'pleiotropic' effects of statins, they improve osteoblasts function and suppress function of osteoclast leading to enhanced bone formation. Therefore, they might improve odontoblastic function resulting in improved dentin formation. Statins are also thought to induce angiogenesis and increase neuronal cell. Consequently, they play a role in pulp regeneration along with dentin regeneration. In addition, sufficient evidence exists in support of the potent anti-inflammatory properties of statins, they reduce circulating C-reactive protein (CRP) and pro-inflammatory cytokines, lowering the amount of interleukin-6 and interleukin-8 in inflamed pulpal tissues.
Owing to limited availability of data in researches and in order to reach conclusive results on whether pulpotomy can be offered as an alternate treatment to pulpectomy in vital primary molars diagnosed with irreversible pulpitis, our study aims to evaluate clinical and radiographic success of of pulpotomy using 3Mixtatin versus pulpectomy using Metapex with vital primary molars diagnosed with symptomatic irreversible pulpitis in children aged 4 to 9 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metapex pulpectomy | Active comparator | Drug: MetapexSingle-visit pulpectomy using Metapex, . Calcium hydroxide-iodoform mixture (Metapex) is an ideal pulpal filling material for primary teeth. |
| 3Mixtatin Pulpotomy | Experimental | Drug: 3Mixtatinpulpotomy with 3 mixtatin (triple antibiotic paste of (Metronidazole, cefixime, and Ciprofloxacin mixed with simvastatin ) applied in the vital pulp therapy |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged from 4 to 9 years with vital primary molars showing signs of irreversible pulpitis.
- Children with spontaneous pain lasting a few seconds to several hours.
- Pain is intensified by thermal stimulus and persists after its removal.
- Pulp hemorrhage after performing access cavity and deroofing of pulp chamber showing reddish pink healthy pulp tissue.
- Radicular pulp health is verified by achieving hemostasis within eight minutes of compression using a cotton pellet with 5% sodium hypochlorite.
Key exclusion criteria (6 listed)
- Unrestorable primary molars.
- Primary molars with uncontrolled pulp hemorrhage or pulp necrosis.
- Medically compromised patients who have systemic disease.
- Uncooperative children who refuse treatment.
- Children whose parents are unwilling to place stainless steel crowns.
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 |
|---|---|---|
| MetapexPulpectomy using Metapex | Drug | metapex pulpectomy |
| 3Mixtatinpulpotomy treatment when applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin | Drug | 3Mixtatin Pulpotomy |
Primary outcome
Clinical success
Time frame: 3, 6, 9, and 12 months follow-up period
* Pain to percussion will be assessed by applying a light-tapping force to the relevant tooth using the blunt end of the dental probe. Tapping will be applied as gently as possible from a 1 cm distance, either present or absent. * Swelling will be assessed through clinical examination, either present or absent. * The sinus tract or fistula will be assessed through clinical examination, either present or absent. * The mobility of teeth will be assessed by applying pressure to the ends of two metal instruments, either present or absent. * The principal investigator and the co-supervisor will undertake this clinical assessment on every recall visit during the 3, 6, 9, and 12 months follow-up period.
2 secondary outcomes
Radiographic Success
Time frame: 6 and 12 months
Post operative pain
Time frame: 1 week, 3, 6, 9, and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- 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.
Marwa Aly Fouad, Associate Professor contact
Osama Ibrahim El Shahawy, Professor study director
Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
Marwa Aly Fouad, Associate professor study chair
Associate Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metapex and 3Mixtatin in people with Irreversible Pulpitis and Primary Teeth, 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 6 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: opening soon, as of the sponsor's last update on 27 Apr 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nora Mohamed Mosaad, PHD researcher (00201000921189, nora.mosaad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 3, 6, 9, and 12 months follow-up period). 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 27 Apr 2025.