An interventional study of Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical): and Group ( 2) Experimental group modified 3-MIX-TATIN): in Necrotic Pulp and Primary Teeth, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 5 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-31.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
Among 43 studies in Dental Pulp Necrosis with a site in Egypt — 12 open to participants now, 16 under way, 1 of them phase 3. Dental Pulp Necrosis · Egypt.
Among the 43 studies in Dental Pulp Necrosis with a site in Egypt, this one is the 30th largest by planned enrollment, is one of 3 that started in 2024, is one of 31 with no phase, reaches primary completion later than 2 of the 15 other live ones, and was the 26th registered.
157 studies on the registry are indexed under Dental Pulp Necrosis; 44 are open to participants now.
Browse Dental Pulp Necrosis studies →12 of the 43 studies in Dental Pulp Necrosis with a site in Egypt are open now. Recruiting first, the newest first:
Mansoura University · Sites in Egypt
Ages 8–18
October 6 University · Sites in Egypt
Ages 21–50
Cairo University · Sites in Egypt
Ages 18–40 · Healthy volunteers
Kafrelsheikh University · Sites in Egypt
Ages 9–15 · Healthy volunteers
Mansoura University · Sites in Egypt
Ages 20–60 · Healthy volunteers
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 15 Dental Pulp Necrosis studies recruiting now, 6 (40%) set no upper age limit and 7 (47%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 5 Years to 7 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.
43 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 2 · Phase 2 6 · Phase 3 1 · Phase 4 4
First in 2016; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 34 is below the median of 45 across 148 interventional studies indexed under Dental Pulp Necrosis.
Median enrollment 40 across the 43 interventional studies. Of the 22 that completed or were terminated, 1 (5%) have results posted.
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None of the 43 has an industry lead sponsor. The 10 most frequent:
Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Ain Shams University has 5 studies filed under Dental Pulp Necrosis — fewer than ten, so there is no comparison to draw.
9 of the studies in Dental Pulp Necrosis with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07371416Mansoura UniversityRegenerative Root Canal Treatment of Immature Teeth Using Omega-3 Fatty Acids | 2026-12 |
| NCT07747753Ahmed Hesham Abdelmohaimen RezkComparison of Post-operative Pain and Levels of MMP -9 Following Root Canal Irrigation With Sodium Hypochlorite Versus Cold Atmospheric Plasma in Patient With Necrotic Single Rooted Teeth: Randomized Clinical Trial | 2027-01 |
| NCT07897591October 6 UniversityConventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis | 2027-01 |
| NCT07790796Future University in EgyptEvaluation of Post-operative Pain and Bacterial Load Reduction After Application of Three Intra-canal Medications (Cocoa Husk Versus Calcium Hydroxide With and Without Cocoa) in Necrotic Mandibular First Molar. | 2027-01-06 |
| NCT07388888Ain Shams UniversityAntibacterial Effect of Two Different Intracanal Medicaments and Their Effect on Post-operative Pain | 2027-02 |
Add all 9 to your calendar (.ics) → With an account.
Among the 43 studies in Dental Pulp Necrosis with a site in Egypt, from their registry updates:
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Primary molars with necrotic pulp or abscess are common unfortunate event faced in pediatric dentistry .The traditional treatment is either pulpectomy or extraction. ٍuccess of pulpectomy treatment is about 85% in abscessed primary teeth.
The aim of pulpectomy is to preserve teeth in a symptom free state until they are replaced by their successor naturally during the transition from primary to permanent dentition, thus avoiding extraction. The adequate restoration of the involved teeth may preserve the arch length reestablish the masticatory function and esthetics and prevent harmful tongue habits and speech alterations due to anterior teeth decay.
The techniques available for management of necrotic primary molars are either pulpectomy or extraction, but according to guidelines American Academy of Pediatric Dentistry, extraction and space maintainer is a viable option but a successfully restored tooth is far superior space maintainer than an appliance. So preservation of primary molars is not only important for masticatory function but also for preservation of developing occlusion.
The rationale includes the chemical and mechanical removal of irreversibly inflamed or necrotic radicular pulp tissue, followed by root canal filling with a material that can resorb at the same rate as the primary tooth and be eliminated rapidly if accidentally extruded through the apex and have the ability for disinfection of pulpal and periapical lesion.
In this study 2 medications will be used as root canal filling. First is the mixture of zinc oxide eugenol based sealer (ZicalR) and 3mixtatin which is composed of 3 antibiotics (ciprofloxacin, cefixime, metronidazole), simvastatin, and zinc oxide the term 3mix-tatin as an acronym for the mixture of triple mixture antibiotics and simvastatin. Statin components are emerging material in regenerative endodontics. Clinical and experimental trials proved the pleiotropic effect of statin, as it increases the osteoblastic function and suppresses the osteoclastic function. In addition to that, evidence proved that it is a potent anti -inflammatory as it reduce the CRP and pro-inflammatory cytokines. Second medication will be Zical which is a zinc oxide eugenol based sealer composed of Zinc Oxide, Bismuth Sub-carbonate, Barium Sulphate, Sodium Borate, Iodoform, and Hydrogenated Resin. Liquid contains: Eugenol.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Local anesthesia administration and rubber dam isolation will be carried out Access cavity will be prepared, necrotic pulp tissue will be removed using a sterile sharp spoon excavator. Cleaning and shaping of the root canals will be carried out using H files and continuous irrigation. Canal irrigation with 2.5% sodium hypochlorite will be carried out throughout the procedure. Sterile paper points will be used to dry the root canals. Zinc oxide eugenol based sealer (Zical) will be mixed into a thick paste and packed into the pulp chamber to fill the canal. (Chen\& Zhong., 2017; Pramila., 2015) The access opening will be sealed with a glass ionomer cement , and the tooth will be restored with a stainless steel crown.
Other: Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical):
dified 3Mix-tatin will be prepared by mixing three commercially available antibiotics with simvastatin. After removing the coating materials, 3 types of antibiotics are pulverized by porcelain mortars and pestles to achieve fine powders. A total of 100 mg ciprofloxacin, 100 mg metronidazole, and 100 mg cefixime will be mixed in a ratio of 1: 1: 1. Two milligrams of simvastatin will be added to the drugs blend to form 3-Mix-tatin. Preparation of 3Mix-tatin will be trained and supervised by an expert pharmacist. 3Mixtatin will be stored in a tightly capped porcelain container, adding of silica gel in a bag inside the container to maintain low humidity. This powder will be mixed with zinc oxide eugenol based sealer called Zical which will act as a carrier or vehicle to form a creamy paste of 3Mixtatin at the time of application (Aminabadi et al., 2015; carvalho., 2016).
Other: Group ( 2) Experimental group modified 3-MIX-TATIN):
Zinc oxide eugenol based sealer (Zical) will be mixed into a thick paste and packed into the pulp chamber to fill the canal.
Modified 3Mix-tatin will be prepared by mixing three commercially available antibiotics with simvastatin. This powder will be mixed with zinc oxide eugenol based sealer called Zical which will act as a carrier or vehicle to form a creamy paste of 3Mixtatin at the time of application
postoperative pain
spontaneous pain, as reported by the caregivers through visual analogue score (VAS)from 1 to 10 where 1 means : minimal pain , 10 means:: severe pain
Time frame: first week after treatment, 3 months, 6 months, 12 months
Root resorption
Presence of Radiographic internal or external root resorption in periapical radiograph using parallel technique
Time frame: preoperative, 3rd month, 6 month, 12 month
Bone resorption
Presence of Radiographic bone resorption in periapical radiograph technique of Radiograph: extension cone paralelling periapical radiograph (XCP)
Time frame: preoperative, 3 , 6 , 12 month
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Jan 2025, 12 months after the start.
Of 66 non-industry interventional studies with no phase under Dental Pulp Necrosis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 12 months is below that.
Counting every sponsor, half of 67 studies reached it within 15 months; a quarter within 9 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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