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

February 1, 2026 updated by: Nanis Nasser Anwar Moustafa, October University for Modern Sciences and Arts

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Preservation of primary teeth is essential for maintaining proper mastication, speech development, and arch integrity, as well as for preventing psychological and functional complications arising from premature tooth loss. Pulpectomy remains the treatment of choice for irreversibly infected or necrotic primary teeth, yet the complex root canal morphology, resorptive nature of primary roots, and behavioral management challenges make such procedures technically demanding.

An ideal root canal filling material for primary teeth should be antibacterial, biocompatible, radiopaque, and resorbable at a rate consistent with natural root resorption. It must also be easily manipulated, removable if necessary, and capable of hermetic sealing. Among the commonly used materials, Zinc Oxide Eugenol (ZOE) has long been considered the standard due to its antimicrobial and sealing properties; however, its slow resorption and potential for periapical irritation are significant drawbacks. Conversely, Metapex, a premixed iodoform-calcium hydroxide paste, exhibits superior biocompatibility, antibacterial effects, and resorption rates that align more closely with physiological root resorption, making it a promising alternative.

Similarly, biomechanical preparation of root canals can be performed manually or using nickel-titanium (NiTi) rotary systems. Manual instrumentation provides tactile feedback and precision but is time-consuming and operator-dependent. Rotary systems, on the other hand, offer improved efficiency, shaping consistency, and reduced chair time-important factors in managing pediatric patients-though they require training and careful use to prevent over-preparation.

This study will enroll 44 primary molars from cooperative, systemically healthy children aged 5-8 years who are indicated for pulpectomy. The teeth will be randomly allocated into four groups:

Rotary instrumentation with Metapex,

Rotary instrumentation with ZOE,

Manual instrumentation with Metapex, and

Manual instrumentation with ZOE.

Clinical evaluation will include assessment of pain using the Wong-Baker FACES Pain Rating Scale, mobility using Miller's Mobility Index, and sensitivity using the Numeric Rating Scale (NRS). Radiographic evaluation will be performed using CBCT at baseline, 6, and 12 months to assess root resorption and bone density changes. The primary outcome is radiographic success, defined by physiological resorption and bone healing, while secondary outcomes include clinical success indicators such as absence of pain, swelling, or abnormal mobility.

Data will be statistically analyzed using SPSS (v24). Quantitative variables will be tested for normality and compared using ANOVA or Kruskal-Wallis tests, while qualitative data will be analyzed using Chi-square tests.

The findings are expected to clarify whether Metapex or ZOE, when used with rotary or manual preparation techniques, provides superior clinical and radiographic outcomes. Ultimately, the results may guide clinicians toward more effective, biocompatible, and time-efficient pulpectomy protocols in pediatric endodontics, contributing to improved long-term oral health outcomes in children.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Giza Governorate
      • Giza, Giza Governorate, Egypt, 12611
        • Recruiting
        • Faculty of Dentistry, MSA University
        • Contact:
        • Principal Investigator:
          • nanis nasser, bachelor degree of dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Apparently healthy cooperative children indicated for partial pulpectomy.
  2. Restorable primary molars.
  3. No mobility, or external pathological root resorption.

Exclusion Criteria:

  1. Uncooperative children.
  2. Children with systemic medical illness.
  3. More than 2/3 of root resorbed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Manual Instrumentation and Metapex
Primary molar teeth will undergo pulpectomy using Manual instrumentation followed by obturation with iodoform-calcium hydroxide paste (Metapex).
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.
Experimental: Arm B: Rotary Instrumentation and Metapex
Primary molar teeth will undergo pulpectomy using rotary instrumentation followed by obturation with iodoform-calcium hydroxide paste (Metapex).
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.
Active Comparator: Arm C: Manual Instrumentation and ZOE
Primary molar teeth will undergo pulpectomy using manual instrumentation followed by obturation with zinc oxide eugenol (ZOE).
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: 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.
Active Comparator: Arm D: Rotary Instrumentation and ZOE
Primary molar teeth will undergo pulpectomy using rotary instrumentation followed by obturation with zinc oxide eugenol (ZOE).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Success
Time Frame: Baseline, 6 months, and 12 months
Radiographic success will be assessed by evaluating root resorption in treated primary molars. Cone Beam Computed Tomography (CBCT) will be used to measure the degree of root resorption in millimeters, allowing comparison between zinc oxide eugenol (ZOE) and iodoform-calcium hydroxide (Metapex) obturation materials in canals prepared by rotary and manual instrumentation techniques.
Baseline, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: Baseline, 6 months, and 12 months
Pain will be evaluated using the Wong-Baker FACES Pain Rating Scale. Patients will self-report pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable) during follow-up visits after pulpectomy.
Baseline, 6 months, and 12 months
Tooth Mobility
Time Frame: Baseline, 6 months, and 12 months
Tooth mobility will be assessed clinically using Miller's Mobility Index by applying gentle pressure with a dental instrument to evaluate the degree of horizontal and vertical movement of the treated primary molars where 0 (no mobility) to 3 (more than 1mm vertical and horizontal mobility) during clinical examination.
Baseline, 6 months, and 12 months
Tooth Sensitivity
Time Frame: Baseline, 6 months, and 12 months
Tooth sensitivity will be evaluated using the Numeric Rating Scale (NRS), where patients will rate sensitivity from 0 (no sensitivity) to 10 (extreme sensitivity) during clinical examination.
Baseline, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October University for Modern Sciences and Arts

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

February 1, 2026

First Submitted That Met QC Criteria

February 1, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U MSA Nanis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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