Carious Primary MolarsNCT07265063
Pulpotomy With CEM vs Pulpectomy With Ca(OH)2/Iodoform in Primary Molars
A study testing Pulpotomy using Calcium-Enriched Mixture (CEM) Cement and Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex) in people with Carious Primary Molars, run by Cairo University.
Trial summary
Will Calcium-Enriched Mixture (CEM) cement pulpotomy have less postoperative pain and more clinical and radiographic success compared to Calcium Hydroxide/Iodoform (Metapex) pulpectomy when managing second primary molars with irreversible pulpitis? Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Primary Molars
- What is being tested?
- Pulpotomy using Calcium-Enriched Mixture (CEM) Cement and Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Dec 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children:
- Aged 6-8 years of both sexes. Cooperative and medically free. Diagnosed with irreversible pulpitis based on clinical and radiographic criteria.
- Parents/legal guardians provide written informed consent. Parents able to attend follow-up visits.
- Teeth:
- Deep carious second primary molars with signs of irreversible pulpitis. No clinical signs of necrosis (abscess, fistula, mobility). No radiographic signs of necrosis (periapical lesion or resorption).
Who cannot join
- Children:
- With systemic or mental disorders. Whose parents refuse to give consent. Uncooperative behavior.
- Teeth:
- Signs of pulpal necrosis (swelling, fistula, pathological mobility). Periapical or furcal radiolucency exceeding half the furcation-apical distance. Non-restorable teeth, root caries, internal/external resorption, or calcified canals.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Alaa Hassab Elrasoul Abdelmajed, Master degree contact
About this study
Official title: Clinical and Radiographic Evaluation of Pulpotomy Using Calcium-Enriched Mixture Versus Pulpectomy Using Calcium Hydroxide/Iodoform Paste for the Treatment of Primary Molars With Irreversible Pulpitis: A Randomized Clinical Trial
Will Calcium-Enriched Mixture (CEM) cement pulpotomy have less postoperative pain and more clinical and radiographic success compared to Calcium Hydroxide/Iodoform (Metapex) pulpectomy when managing second primary molars with irreversible pulpitis?
- Conditions
- Carious Primary Molars
- Being tested
- Pulpotomy using Calcium-Enriched Mixture (CEM) Cement, Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpotomy using Calcium-Enriched Mixture (CEM) CementProcedure or surgery
pulpotomy procedure using (CEM) Cement as pulp dressing material
Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)Procedure or surgery
pulpectomy procdure performed using Metapex paste as root canal filling material
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy Group | Experimental | Children in this group will undergo pulpotomy of second primary molars diagnosed with irreversible pulpitis using Calcium-Enriched Mixture (CEM) cement. The procedure includes coronal pulp removal, hemostasis, placement of CEM cement as a base over the pulp tissue, and final restoration with glass ionomer cement followed by stainless steel crown. Receives: Procedure: Pulpotomy using Calcium-Enriched Mixture (CEM) Cement |
| pulpectomy group | Experimental | Children in this group will undergo pulpectomy of second primary molars diagnosed with irreversible pulpitis using Calcium Hydroxide/Iodoform paste (Metapex). The procedure includes complete removal of the pulp tissue, canal instrumentation and irrigation, obturation with Metapex, and final restoration with glass ionomer cement followed by stainless steel crown. Receives: Procedure: Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Pain intensity will be evaluated using the Visual Analog Scale (VAS) of faces, rated from 0 (no pain) to 5 (severe pain). Assessment will be performed at 1, 3, 6, 9, and 12 months after treatment. Clinical success will be considered when the patient reports no pain (score = 0).
Measured: 1, 3, 6, 9, and 12 months post-treatment
Secondary outcomes (2)
Evaluation of Clinical Success
Clinical success will be evaluated by the absence of pain, swelling, tenderness to percussion, sinus, fistula, and pathological mobility. Clinical assessment will be performed at 1, 3, 6, 9, and 12 months postoperatively.
Measured: 1, 3, 6, 9, and 12 months post-treatment
Evaluation of Radiographic Success
Radiographic success will be defined as the absence of widening of the periodontal ligament space, internal/external root resorption, or radiolucency in the furcation or periapical area. Radiographic failure will be recorded if any of these findings are observed.
Measured: 6 and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 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 MolarsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Hassab Elrasoul Abdelmagid Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265063
- Sponsor's protocol ID
- CEMvsCHIP2025
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Pulpotomy Using Calcium-Enriched Mixture Versus Pulpectomy Using Calcium Hydroxide/Iodoform Paste for the Treatment of Primary Molars With Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07265063
- Acronym / sponsor ID
- CEMvsCHIP2025
- Conditions
- Carious Primary Molars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Dec 2025 (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.
Will Calcium-Enriched Mixture (CEM) cement pulpotomy have less postoperative pain and more clinical and radiographic success compared to Calcium Hydroxide/Iodoform (Metapex) pulpectomy when managing second primary molars with irreversible pulpitis?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy Group | Experimental | Procedure: Pulpotomy using Calcium-Enriched Mixture (CEM) CementChildren in this group will undergo pulpotomy of second primary molars diagnosed with irreversible pulpitis using Calcium-Enriched Mixture (CEM) cement. The procedure includes coronal pulp removal, hemostasis, placement of CEM cement as a base over the pulp tissue, and final restoration with glass ionomer cement followed by stainless steel crown. |
| pulpectomy group | Experimental | Procedure: Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)Children in this group will undergo pulpectomy of second primary molars diagnosed with irreversible pulpitis using Calcium Hydroxide/Iodoform paste (Metapex). The procedure includes complete removal of the pulp tissue, canal instrumentation and irrigation, obturation with Metapex, and final restoration with glass ionomer cement followed by stainless steel crown. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children:
- Aged 6-8 years of both sexes. Cooperative and medically free. Diagnosed with irreversible pulpitis based on clinical and radiographic criteria.
- Parents/legal guardians provide written informed consent. Parents able to attend follow-up visits.
- Deep carious second primary molars with signs of irreversible pulpitis. No clinical signs of necrosis (abscess, fistula, mobility). No radiographic signs of necrosis (periapical lesion or resorption).
Key exclusion criteria (4 listed)
- Children:
- With systemic or mental disorders. Whose parents refuse to give consent. Uncooperative behavior.
- Signs of pulpal necrosis (swelling, fistula, pathological mobility). Periapical or furcal radiolucency exceeding half the furcation-apical distance. Non-restorable teeth, root caries, internal/external resorption, or calcified canals.
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 |
|---|---|---|
| Pulpotomy using Calcium-Enriched Mixture (CEM) Cementpulpotomy procedure using (CEM) Cement as pulp dressing material | Procedure or surgery | Pulpotomy Group |
| Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)pulpectomy procdure performed using Metapex paste as root canal filling material | Procedure or surgery | pulpectomy group |
Primary outcome
Postoperative Pain Intensity
Time frame: 1, 3, 6, 9, and 12 months post-treatment
Pain intensity will be evaluated using the Visual Analog Scale (VAS) of faces, rated from 0 (no pain) to 5 (severe pain). Assessment will be performed at 1, 3, 6, 9, and 12 months after treatment. Clinical success will be considered when the patient reports no pain (score = 0).
2 secondary outcomes
Evaluation of Clinical Success
Time frame: 1, 3, 6, 9, and 12 months post-treatment
Evaluation of Radiographic Success
Time frame: 6 and 12 months post-treatment
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 4 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Alaa Hassab Elrasoul Abdelmajed, Master degree contact
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy using Calcium-Enriched Mixture (CEM) Cement and Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex) in people with Carious Primary Molars, run by Cairo University.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Alaa Hassab Elrasoul Abdelmajed, Master degree (00201507339601, alaa.abdelmagid@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: 1, 3, 6, 9, and 12 months post-treatment). 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 4 Dec 2025; AzTrials last refreshed its copy on 2 Nov 2026.