A Phase 1 interventional study of Metapex and 3Mixtatin in Irreversible Pulpitis, Primary Teeth and Pulp Disease, Dental, sponsored by Cairo University. Not yet recruiting. Open to participants aged 4 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Cairo University · Phase 1, Interventional, and Treatment
Among 14 studies in Dental Pulp Diseases by Cairo University — 8 open to participants now, 8 under way, 1 of them phase 3. Dental Pulp Diseases · Cairo University.
Among the 14 studies in Dental Pulp Diseases by Cairo University, this one is the 2nd largest by planned enrollment of the 13 interventional ones that give a count, is one of 4 that started in 2025, is one of 3 in phase 1, and was the 13th registered.
130 studies on the registry are indexed under Dental Pulp Diseases; 37 are open to participants now.
Browse Dental Pulp Diseases studies →8 of the 14 studies in Dental Pulp Diseases by Cairo University are open now, in 1 country. Recruiting first, the newest first:
Cairo University · Sites in Egypt
Ages 4–8
Cairo University · Sites in Egypt
Ages 4–7 · Healthy volunteers
Cairo University · Sites in Egypt
Ages 4–8
Cairo University
Ages 3–7
Cairo University
Ages 4–7
By country, each count listing its studies:
Of the 16 Dental Pulp Diseases studies recruiting now, 5 (31%) set no upper age limit and 10 (63%) stop at 75 or younger; 5 take children under 18; 12 take healthy volunteers.
This study: 4 Years to 9 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 2 · Phase 3 1
First in 2017; this study’s year is marked. 4 started in 2025.
This study's planned enrollment of 50 is close to the median of 52 across 108 interventional studies indexed under Dental Pulp Diseases.
Median enrollment 50 across the 13 interventional studies, 335 across the 1 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
1 of the studies in Dental Pulp Diseases by Cairo University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07675330Cairo UniversityOxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars | 2026-12 |
Among the 14 studies in Dental Pulp Diseases by Cairo University, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Single-visit pulpectomy using Metapex, . Calcium hydroxide-iodoform mixture (Metapex) is an ideal pulpal filling material for primary teeth.
Drug: Metapex
pulpotomy with 3 mixtatin (triple antibiotic paste of (Metronidazole, cefixime, and Ciprofloxacin mixed with simvastatin ) applied in the vital pulp therapy
Drug: 3Mixtatin
Pulpectomy using Metapex
pulpotomy treatment when applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin
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.
Time frame: 3, 6, 9, and 12 months follow-up period
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.
Time frame: 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.
Time frame: 1 week, 3, 6, 9, and 12 months.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2025; primary completion for Sep 2026, 15 months later.
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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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