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.
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
- Conditions the study is for
- Carious Primary Molars Indicated for Pulpectomy
- 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.
Egypt1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Arm A: Manual Instrumentation and Metapex | Experimental | Primary 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 Metapex | Experimental | Primary 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 ZOE | Active comparator | Primary 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 ZOE | Active comparator | Primary 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.
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)
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
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
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.
- First posted9 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious Primary Molars Indicated for PulpectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nanis Nasser Anwar Moustafa, October University for Modern Sciences and Arts
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07395401
- Acronym / sponsor ID
- U MSA Nanis
- Keywords
- Iodoform-Calcium Hydroxide, Metapex, Zinc Oxide Eugenol, Manual Instrumentation Method, Rotary Instrumentation Method, pulpectomy, primary molars, radiographic assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: Manual Instrumentation and Metapex | Experimental | Procedure: Manual Instrumentation, Drug: Iodoform-Calcium Hydroxide (Metapex)Primary molar teeth will undergo pulpectomy using Manual instrumentation followed by obturation with iodoform-calcium hydroxide paste (Metapex). |
| Arm B: Rotary Instrumentation and Metapex | Experimental | Drug: Iodoform-Calcium Hydroxide (Metapex), Procedure: Rotary InstrumentationPrimary molar teeth will undergo pulpectomy using rotary instrumentation followed by obturation with iodoform-calcium hydroxide paste (Metapex). |
| Arm C: Manual Instrumentation and ZOE | Active comparator | Procedure: Manual Instrumentation, Drug: Zinc Oxide Eugenol (ZOE)Primary molar teeth will undergo pulpectomy using manual instrumentation followed by obturation with zinc oxide eugenol (ZOE). |
| Arm D: Rotary Instrumentation and ZOE | Active comparator | Procedure: Rotary Instrumentation, Drug: Zinc Oxide Eugenol (ZOE)Primary molar teeth will undergo pulpectomy using rotary instrumentation followed by obturation with zinc oxide eugenol (ZOE). |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Apparently healthy cooperative children indicated for partial pulpectomy.
- Restorable primary molars.
- No mobility, or external pathological root resorption.
Key exclusion criteria (3 listed)
- Uncooperative children.
- Children with systemic medical illness.
- More than 2/3 of root resorbed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual InstrumentationRoot 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. | Procedure or surgery | Arm A: Manual Instrumentation and Metapex, Arm C: Manual Instrumentation and ZOE |
| 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. | Drug | Arm A: Manual Instrumentation and Metapex, Arm B: Rotary Instrumentation and Metapex |
| Rotary InstrumentationRoot 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. | Procedure or surgery | Arm B: Rotary Instrumentation and Metapex, Arm D: Rotary Instrumentation and ZOE |
| 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. | Drug | Arm C: Manual Instrumentation and ZOE, Arm D: Rotary Instrumentation and ZOE |
Primary outcome
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.
3 secondary outcomes
Postoperative Pain
Time frame: Baseline, 6 months, and 12 months
Tooth Mobility
Time frame: Baseline, 6 months, and 12 months
Tooth Sensitivity
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.