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

NCT07395401 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-02-09

No results posted yet for this study

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.

Conditions

  • Carious Primary Molars Indicated for Pulpectomy

Interventions

PROCEDURE

Manual 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.

DRUG

Iodoform-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.

PROCEDURE

Rotary 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.

DRUG

Zinc 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.

Sponsors & Collaborators

  • October University for Modern Sciences and Arts

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2026-03-01
Completion
2026-03-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07395401 on ClinicalTrials.gov