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NCT Number: NCT07265063

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

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?

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Key information

Conditions

Carious Primary Molars

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulpotomy using Calcium-Enriched Mixture (CEM) Cement

Procedure

pulpotomy procedure using (CEM) Cement as pulp dressing material

Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)

Procedure

pulpectomy procdure performed using Metapex paste as root canal filling material

Primary outcomes

  1. Postoperative Pain Intensity

    Time frame: 1, 3, 6, 9, and 12 months post-treatment

    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).

Secondary outcomes

  1. Evaluation of Clinical Success

    Time frame: 1, 3, 6, 9, and 12 months post-treatment

    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.

  2. Evaluation of Radiographic Success

    Time frame: 6 and 12 months post-treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Hassab Elrasoul Abdelmajed, Master degree

CONTACT

[email protected]

00201507339601

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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