NCT06752889

Clinical and Radiographic Evaluation of Zinc Oxide Modified 3Mixtatin Versus Zical in Root Canal Treatment of Necrotic Primary Molars.

Clinical and Radiographic Evaluation of Zinc Oxide Modified 3Mixtatin Versus Zical Root Canal Sealer in Root Canal Treatment of Necrotic Primary Molars.(A Randomized Clinical Trial and in Vitro Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Necrotic Pulp
• Primary Teeth

Interventions

Type	Name	Description
OTHER	Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical):	Zinc oxide eugenol based sealer (Zical) will be mixed into a thick paste and packed into the pulp chamber to fill the canal.
OTHER	Group ( 2) Experimental group modified 3-MIX-TATIN):	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

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-01-01
• Completion: 2025-02-01
• First posted: 2024-12-31
• Last updated: 2024-12-31

Locations

1 site across 1 country: Egypt