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

NCT07265063 | Not Yet Recruiting

• 1 other identifier: CEMvsCHIP2025
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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?

Conditions

Carious Primary Molars

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of Clinical Success

  1, 3, 6, 9, and 12 months post-treatment

• Evaluation of Radiographic Success

  6 and 12 months post-treatment

Study Arms (2)

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.

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.

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

Interventions

Pulpotomy using Calcium-Enriched Mixture (CEM) Cement PROCEDURE

pulpotomy procedure using (CEM) Cement as pulp dressing material

Pulpotomy Group

Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex) PROCEDURE

pulpectomy procdure performed using Metapex paste as root canal filling material

pulpectomy group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

omega-Chloroacetophenone; Dental Cements; Metapex

Intervention Hierarchy (Ancestors)

Acetophenones; Ketones; Organic Chemicals; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Alaa Hassab Elrasoul Abdelmajed, Master degree

CONTACT

00201507339601; alaa.abdelmagid@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share