Pulpotomy With CEM vs Pulpectomy With Ca(OH)2/Iodoform in Primary Molars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulpotomy using Calcium-Enriched Mixture (CEM) Cement, Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex).
- Who it may be relevant to
- Registry conditions: Carious Primary Molars. Basic parameters: 6 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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?
Interventions
- Procedure Pulpotomy using Calcium-Enriched Mixture (CEM) Cement
pulpotomy procedure using (CEM) Cement as pulp dressing material - Procedure Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)
pulpectomy procdure performed using Metapex paste as root canal filling material
Primary outcome measures
- Postoperative Pain Intensity [Time frame: 1, 3, 6, 9, and 12 months post-treatment]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07265063 · CEMvsCHIP2025