Clinical and Radiographic Evaluation of E-IodoCal in Primary Molar Pulpectomy

NCT07883200 · tracked via the Priya Life Science Egypt tracker

Sponsor

Tanta University

Phase

Not applicable

Started

2025-11-25

Last updated

2026-10-20

Condition(s) studied

PulpectomyPulpitis - IrreversibleZinc OxideRoot Canal Obturation

Investigational drug(s) / intervention(s)

E-IodoCal Root Canal Obturation (Group I)Zinc Oxide-Eugenol Root Canal Obturation (Group II)

E-IodoCal Root Canal Obturation (Group I): 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.

Zinc Oxide-Eugenol Root Canal Obturation (Group II): 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

4 Years

Max age

8 Years

Healthy volunteers

Inclusion Criteria: Clinical: - * Healthy cooperative children with an age range of 4 - 8 years. * Nonvital deep carious mandibular primary second molars with sufficient coronal structure and at least 2/3rd root structure intact. * Pulp exposure where bleeding couldn't be stopped following removal of the coronal pulp tissue * Previous history of irreversible pulpitis signs and symptoms as spontaneous pain, percussion sensitivity, fistulous tract related to the involved tooth, and pathologic tooth mobility (grade-I mobility) Radiographic: * Adequate alveolar bone support (coverage by the bone of minimum two- thirds of at least one root). * Presence of interradicular radiolucency (discontinuity of lamina dura and/or furcation involvement less than or equal to half of the shortest root). Exclusion Criteria: Clinical: * Non-restorable primary molars with severe mobility (greater than grade-I mobility). * Children with systemic illness (any medically compromising condition). * Primary molars beyond possible repair. Radiographic: * Extensive internal resorption. * Extensive external pathological root resorption. * Obliteration of the root canal. * Physiological root resorption of more than a third of its length.

Primary outcome measure(s)

Clinical Success Rate — Evaluated at 3, 6, and 9 months post-operative.
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.
Radiographic Success Rate — Evaluated at 3, 6, and 9 months post-operative.
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.

Trial sites (1)

Facility	City	Region	Status
faculty of dentistry, Tanta university	Tanta	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07883200 on ClinicalTrials.gov ↗ ← All trials in Egypt