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

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Carious Primary Molars
• Intervention / Treatment: Procedure: Pulpotomy using Calcium-Enriched Mixture (CEM) Cement; Procedure: Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa Hassab Elrasoul Abdelmajed, Master degree; Phone Number: 00201507339601; Email: alaa.abdelmagid@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Pulpotomy using Calcium-Enriched Mixture (CEM) Cement; pulpotomy procedure using (CEM) Cement as pulp dressing material
Experimental: 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.	Procedure: Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex); pulpectomy procdure performed using Metapex paste as root canal filling material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1, 3, 6, 9, and 12 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 and 12 months post-treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Ketones; Dental Materials; Acetophenones; omega-Chloroacetophenone; Metapex; Dental Cements
• Other Study ID Numbers: CEMvsCHIP2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No