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

Not Applicable

Recruiting

• Conditions: Necrotic Pulp; Primary Teeth

• Registration Number: NCT06752889
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-12-21
• Last Update Submitted: 2024-12-21
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-01
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

1. Non-restorable molars or beyond repair, for example: decay reaches to bifurcation, a hard gingival margin cannot be established or infection cannot be eradicated by other mean (Balaji, 2007).
2. Patient with known allergy to any type of antibiotics or anti-hyperlipidemia drugs.
3. Patient with facial cellulitis or lymphadenopathy
4. Lack of patient/parent compliance and cooperation.
5. Refusal of participation or failure to obtain an informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
postoperative pain	first week after treatment, 3 months, 6 months, 12 months	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

Secondary Outcome Measures

Name	Time	Method
Root resorption	preoperative, 3rd month, 6 month, 12 month	Presence of Radiographic internal or external root resorption in periapical radiograph using parallel technique
Bone resorption	preoperative, 3 , 6 , 12 month	Presence of Radiographic bone resorption in periapical radiograph technique of Radiograph: extension cone paralelling periapical radiograph (XCP)

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt