RecruitingNot ApplicableNCT07395401

Evaluation of Zinc Oxide Eugenol and Iodoform-Calcium Hydroxide as Filling Materials in Primary Molar Root Canals Prepared by Rotary and Manual Files

Clinical and Radiographic Evaluation of Zinc Oxide Eugenol (ZOE) and Iodoform-Calcium Hydroxide (Metapex) as Filling Materials in Primary Molar Root Canals Prepared by Rotary and Manual Files: (Randomized Control Trial Study)


Sponsor

October University for Modern Sciences and Arts

Enrollment

44 participants

Start Date

Feb 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized controlled clinical trial aims to compare the clinical and radiographic outcomes of Zinc Oxide Eugenol (ZOE) and Iodoform-Calcium Hydroxide (Metapex) as root canal filling materials in primary molars prepared using either rotary or manual instrumentation techniques. Forty-four teeth from children aged 5-8 years indicated for pulpectomy will be randomly allocated into four equal groups based on the combination of instrumentation method and filling material. Clinical parameters-pain, mobility, and sensitivity-will be assessed using standardized scales, while radiographic outcomes, including root resorption and bone density, will be evaluated using Cone Beam Computed Tomography (CBCT) at baseline, 6 months, and 12 months. The study seeks to determine which obturation material and canal preparation technique yield superior healing, adaptation, and resorption compatible with the physiological process of primary tooth exfoliation. Findings are expected to inform evidence-based selection of endodontic materials and instrumentation methods in pediatric dentistry.


Eligibility

Min Age: 5 YearsMax Age: 8 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two types of filling materials — zinc oxide eugenol and iodoform-calcium hydroxide — used in root canal treatments for baby (primary) molars in children. It also compares whether rotary (machine-assisted) or manual filing techniques produce better results. The goal is to find the safest and most effective approach for treating infected baby teeth. **You may be eligible if...** - You are a generally healthy child who can cooperate during dental treatment - Your baby molar needs a root canal (partial pulpectomy) and is restorable - The tooth does not have unusual mobility or abnormal external root damage **You may NOT be eligible if...** - The child is uncooperative during dental procedures - The child has a systemic medical illness - More than two-thirds of the tooth root has already been resorbed (broken down) Talk to your child's dentist to see if this trial is right for your child.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREManual Instrumentation

Root canal preparation of primary molars will be performed using manual stainless-steel hand files with conventional step-back technique for cleaning and shaping of the root canals.

DRUGIodoform-Calcium Hydroxide (Metapex)

Metapex (iodoform-calcium hydroxide paste) will be used as the obturating material for filling the prepared root canals of primary molars following pulpectomy.

PROCEDURERotary Instrumentation

Root canal preparation of primary molars will be performed using nickel-titanium rotary instruments according to the manufacturer's instructions to achieve effective cleaning and shaping of the root canals.

DRUGZinc Oxide Eugenol (ZOE)

Zinc oxide eugenol paste will be used as the obturating material for filling the prepared root canals of primary molars following pulpectomy.


Locations(1)

Faculty of Dentistry, MSA University

Giza, Giza Governorate, Egypt

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NCT07395401