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Carious Primary Molars Indicated for PulpectomyNCT07395401

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

A study testing Manual Instrumentation, Iodoform-Calcium Hydroxide (Metapex) and Rotary Instrumentation in people with Carious Primary Molars Indicated for Pulpectomy, run by October University for Modern Sciences and Arts at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 8 years
What is being tested?
Manual Instrumentation, Iodoform-Calcium Hydroxide (Metapex) and Rotary Instrumentation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteEgypt
Study dates
15 Feb 2026to 15 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nanis Nasser, bachelor degree of dentistry contact

+201152791000

nanis.nasser1@msa.edu.eg

Egypt1 site, 1 recruiting
  • Faculty of Dentistry, MSA University

    Giza, Giza Governorate, 12611

    nanis Nasser, bachelor degree of dentistry, 01152791000, nanis.nasser1@msa.edu.eg

    nanis nasser, bachelor degree of dentistry

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Manual Instrumentation, Iodoform-Calcium Hydroxide (Metapex), Rotary Instrumentation, Zinc Oxide Eugenol (ZOE)
Keywords
Iodoform-Calcium Hydroxide, Metapex, Zinc Oxide Eugenol, Manual Instrumentation Method, Rotary Instrumentation Method, pulpectomy, primary molars, radiographic assessment, clinical assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual InstrumentationProcedure or surgery

    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.

  • Iodoform-Calcium Hydroxide (Metapex)Drug

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

  • Rotary InstrumentationProcedure or surgery

    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.

  • Zinc Oxide Eugenol (ZOE)Drug

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

Study groups in NCT07395401
Study groupRoleWhat they receive
Arm A: Manual Instrumentation and MetapexExperimentalPrimary molar teeth will undergo pulpectomy using Manual instrumentation followed by obturation with iodoform-calcium hydroxide paste (Metapex).
Receives: Procedure: Manual Instrumentation; Drug: Iodoform-Calcium Hydroxide (Metapex)
Arm B: Rotary Instrumentation and MetapexExperimentalPrimary molar teeth will undergo pulpectomy using rotary instrumentation followed by obturation with iodoform-calcium hydroxide paste (Metapex).
Receives: Drug: Iodoform-Calcium Hydroxide (Metapex); Procedure: Rotary Instrumentation
Arm C: Manual Instrumentation and ZOEActive comparatorPrimary molar teeth will undergo pulpectomy using manual instrumentation followed by obturation with zinc oxide eugenol (ZOE).
Receives: Procedure: Manual Instrumentation; Drug: Zinc Oxide Eugenol (ZOE)
Arm D: Rotary Instrumentation and ZOEActive comparatorPrimary molar teeth will undergo pulpectomy using rotary instrumentation followed by obturation with zinc oxide eugenol (ZOE).
Receives: Procedure: Rotary Instrumentation; Drug: Zinc Oxide Eugenol (ZOE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Success

    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.

    Measured: Baseline, 6 months, and 12 months

Secondary outcomes (3)
  1. Postoperative Pain

    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.

    Measured: Baseline, 6 months, and 12 months

  2. Tooth Mobility

    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.

    Measured: Baseline, 6 months, and 12 months

  3. Tooth Sensitivity

    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.

    Measured: Baseline, 6 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start15 Feb 2026 (estimated)
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion15 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07395401
Sponsor's protocol ID
U MSA Nanis
Status last verified
Oct 2025
First submitted
1 Feb 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Manual Instrumentation, Iodoform-Calcium Hydroxide (Metapex) and Rotary Instrumentation in people with Carious Primary Molars Indicated for Pulpectomy, run by October University for Modern Sciences and Arts at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nanis Nasser, bachelor degree of dentistry (+201152791000, nanis.nasser1@msa.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Success (time frame: Baseline, 6 months, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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