Pulpotomy With CEM vs Pulpectomy With Ca(OH)2/Iodoform in Primary Molars

Cairo University (CU)

Status: Not yet enrolling

Conditions: Carious Primary Molars

Treatments: Procedure: Pulpotomy using Calcium-Enriched Mixture (CEM) Cement; Procedure: Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)

Study type: Interventional

Funder types: Other

Identifiers

NCT07265063

CEMvsCHIP2025

Details and patient eligibility

About

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?

Enrollment: 50 estimated patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Pulpotomy Group

Experimental group

Description:

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.

Treatment:

Procedure: Pulpotomy using Calcium-Enriched Mixture (CEM) Cement

pulpectomy group

Experimental group

Description:

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.

Treatment:

Procedure: Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)