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

NCT ID: NCT07265063

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-01

Brief Summary

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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?

Detailed Description

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Conditions

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Carious Primary Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
statistician

Study Groups

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Pulpotomy Group

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.

Group Type EXPERIMENTAL

Pulpotomy using Calcium-Enriched Mixture (CEM) Cement

Intervention Type PROCEDURE

pulpotomy procedure using (CEM) Cement as pulp dressing material

pulpectomy group

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.

Group Type EXPERIMENTAL

Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)

Intervention Type PROCEDURE

pulpectomy procdure performed using Metapex paste as root canal filling material

Interventions

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Pulpotomy using Calcium-Enriched Mixture (CEM) Cement

pulpotomy procedure using (CEM) Cement as pulp dressing material

Intervention Type PROCEDURE

Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)

pulpectomy procdure performed using Metapex paste as root canal filling material

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Hassab Elrasoul Abdelmagid Mohamed

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Alaa Hassab Elrasoul Abdelmajed, Master degree

Role: CONTACT

00201507339601

Other Identifiers

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CEMvsCHIP2025

Identifier Type: -

Identifier Source: org_study_id

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