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

ConditionCarious Primary Molars
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-8
SponsorCairo University

About this 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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulpotomy using Calcium-Enriched Mixture (CEM) Cement

    Procedure/Surgery

    pulpotomy procedure using (CEM) Cement as pulp dressing material

  • Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex)

    Procedure/Surgery

    pulpectomy procdure performed using Metapex paste as root canal filling material

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Pulpotomy GroupExperimental treatment 1 intervention
Group B: pulpectomy groupExperimental treatment 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

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.

Time frame
1, 3, 6, 9, and 12 months post-treatment
2

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.

Time frame
6 and 12 months post-treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: