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

N/ANot Yet RecruitingNCT07265063

Cairo University50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Carious Primary Molars

Interventions

Pulpotomy using Calcium-Enriched Mixture (CEM) CementPROCEDURE

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

Central Contacts

Alaa Hassab Elrasoul Abdelmajed, Master degree

CONTACT

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

Data from ClinicalTrials.gov

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