An interventional study of E-IodoCal Root Canal Obturation (Group I) and Zinc Oxide-Eugenol Root Canal Obturation (Group II) in Pulpectomy, Pulpitis - Irreversible and Zinc Oxide, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
This randomized controlled split-mouth clinical trial evaluates the clinical and radiographic performance of E-IodoCal paste compared to zinc oxide-eugenol (ZOE) as root canal filling materials in primary molar pulpectomies.
This randomized controlled split-mouth clinical trial evaluates the clinical and radiographic performance of E-IodoCal paste compared to zinc oxide-eugenol (ZOE) as root canal filling materials in primary molar pulpectomies. Sixty non-vital mandibular primary second molars from pediatric patients aged 4 to 8 years are randomly allocated into two equal groups (n=30 molars per group). Following standardized chemo-mechanical root canal preparation, canals are obturated with either E-IodoCal paste (Group I) or ZOE paste (Group II), and teeth are restored with stainless steel crowns. Clinical and radiographic success rates-evaluated via absence of pain, swelling, sinus tracts, pathological mobility, and periapical/interradicular radiolucencies-are assessed at 3, 6, and 9 months post-operative.
Tanta University is the lead sponsor of 987 studies on the registry; 313 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Clinical: -
Radiographic:
Exclusion Criteria:
Clinical:
Radiographic:
Non-vital primary molars undergoing pulpectomy and obturated using pre-mixed E-IodoCal paste (calcium hydroxide, iodoform, and silicone oil).
Procedure: E-IodoCal Root Canal Obturation (Group I)
Non-vital primary molars undergoing pulpectomy and obturated using conventional Zinc Oxide-Eugenol (ZOE) paste.
Procedure: Zinc Oxide-Eugenol Root Canal Obturation (Group II)
Chemo-mechanical preparation: Rubber dam isolation, access opening, pulp tissue removal, working length determination, manual instrumentation up to #30-#35 using 17% EDTA gel lubricant, and standard irrigation with 2.5% sodium hypochlorite and normal saline. Canals are dried with sterile paper points. Obturation: E-IodoCal paste delivered using its pre-packed polypropylene syringe inserted 1 mm short of the apex, withdrawing slowly as canals fill. Restoration: Intermediate glass ionomer base (Medifil) followed by a final stainless steel crown.
Preparation: Identical isolation, access, cleaning, shaping, and drying protocol as Group I. Obturation: ZOE paste carried into canals in small increments using a hand plugger rotated counterclockwise until complete obturation is achieved. Restoration: Identical glass ionomer base and final stainless steel crown placement.
Clinical Success Rate
Measure: Binary evaluation (Success/Failure) based on the complete absence of: Spontaneous or stimulated pain. Soft tissue swelling or draining sinus tract. Pathological tooth mobility. Tenderness to percussion / normal function on biting.
Time frame: Evaluated at 3, 6, and 9 months post-operative.
Radiographic Success Rate
Measure: Binary evaluation (Success/Failure) assessed via standardized digital periapical radiographs based on: Complete absence or reduction in size of periapical/interradicular radiolucency. Absence of pathological root resorption (internal or external). Normal, uniform, and unwidened periodontal ligament space with an intact, unbroken lamina dura.
Time frame: Evaluated at 3, 6, and 9 months post-operative.
Overfill Clearance Rate
Proportion of teeth with extruded obturation material showing complete radiographic resorption of the overfilled paste beyond the anatomical apex without periapical tissue reaction (expressed as a binary percentage: Resorbed vs. Persistent).
Time frame: At 3 months, 6 months, and 9 months post-operative.
Intracanal Material Resorption Rate
Radiographic evaluation of intracanal filling material stability categorized as: Harmonious (resorbing at the same rate as physiological root resorption), Premature (dissolving faster than root resorption leading to hollow-tube effect), or Retarded (not resorbing despite root resorption)
Time frame: At 3 months, 6 months, and 9 months post-operative
Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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