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Comparative Study of Zinc Oxide Eugenol and Metapex in Primary Molar Root Canals

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Study Aim

This study compares the effectiveness of zinc oxide eugenol and Metapex in the treatment of primary molar root canals, by measuring the degree of root resorption using Cone Beam Computed Tomography (CBCT).

What is being tested

Manual Instrumentation

+ Iodoform-Calcium Hydroxide (Metapex)

+ Zinc Oxide Eugenol (ZOE)

ProcedureDrug
Who is being recruted

From 5 to 8 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorOctober University for Modern Sciences and Arts
Study ContactNanis Nasser, bachelor degree of dentistry
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 15, 2026

Actual date on which the first participant was enrolled.

The study focuses on the importance of preserving primary teeth in children for proper chewing, speech development, and maintaining the arch structure. When these teeth get infected or damaged, a procedure called pulpectomy is often performed. This study compares two materials used in this procedure: Zinc Oxide Eugenol (ZOE) and Metapex, a mix of iodoform-calcium hydroxide. The goal is to find which material works better, considering factors like how well they fight bacteria, seal the tooth, and how quickly they break down naturally. This research is crucial as it aims to improve the effectiveness and safety of pulpectomy, ultimately enhancing children's oral health. In this study, 44 primary molars from children aged 5 to 8 will be divided into four groups. Each group will receive a different combination of treatment: either ZOE or Metapex, and either manual or rotary instrumentation for the procedure. The children's progress will be evaluated through clinical assessments like pain, tooth mobility, and sensitivity, and radiographic evaluations using CBCT scans at baseline, 6, and 12 months. The main outcome is to measure the success of the treatment through the resorption of the tooth root and bone healing. The results are expected to provide guidance on the best material and technique to use for pulpectomy in children, leading to more efficient and effective treatments.

Official TitleClinical 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)
Principal SponsorOctober University for Modern Sciences and Arts
Study ContactNanis Nasser, bachelor degree of dentistry
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

44 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 8 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Apparently healthy cooperative children indicated for partial pulpectomy.

Restorable primary molars.

No mobility, or external pathological root resorption.

3 exclusion criteria prevent from participating
Children with systemic medical illness.

Uncooperative children.

More than 2/3 of root resorbed.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
In this group, primary molar teeth will have their pulp removed using manual tools and then filled with a paste called Metapex, which is made from iodoform and calcium hydroxide.

Group II

Active Comparator
In this group, primary molar teeth will have their pulp removed using manual tools and then filled with a material called Zinc Oxide Eugenol (ZOE).

Group III

Experimental
In this group, primary molar teeth will have their root canals cleaned and shaped using rotary instruments, then filled with a paste called Metapex (iodoform-calcium hydroxide).

Group IV

Active Comparator
In this group, primary molar teeth will have their root canals cleaned and shaped using rotary instruments, then filled with a material called Zinc Oxide Eugenol (ZOE).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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Faculty of Dentistry, MSA University

Giza, EgyptOpen Faculty of Dentistry, MSA University in Google Maps
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One Study Center