Comparing MTA Pulpotomy to Root Canal Treatment in Management of Permanent Molars With Irreversible Pulpitis in Children

Phase 4

Not yet recruiting

• Conditions: Irreversible Pulpitis

• Registration Number: NCT06488131
• Lead Sponsor: Ain Shams University

Brief Summary

Dental caries, highly prevalent amongst children, can cause pulpitis. Coronal pulpotomy provides an easier, cost-effective, conservative and biologically-driven treatment option compared to endodontic treatment in mature permanent teeth with irreversible pulpitis.

The aim of the current study is to evaluate postoperative pain, clinical and radiographic outcomes of MTA pulpotomy compared to root canal treatment in children's first permanent molars suffering from irreversible pulpitis.

Detailed Description

In this randomized controlled trial, patients aged 10-14 years suffering from irreversible pulpitis in the first permanent molar with closed apex will be randomly divided into two groups. The first group will receive complete coronal MTA pulpotomy, while the second group will receive endodontic treatment.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study Start: 2024-07
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Healthy male and female children, aged 10 to 14 years
• Signs and symptoms of irreversible pulpitis in carious first permanent molar.

Exclusion Criteria

• Molars with immature roots
• Non-restorable molars, with abnormal mobility or increased probing pocket depth (normal range = 1-3 mm)
• Any indication of pulpal necrosis, such as sinus tract or swelling or no bleeding from orifices after access opening.
• Any signs of periapical or furcal rarefaction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Relief	preoperatively, immediately postoperatively and every 24 hours for 7 days after the first appointment.	A 10 cm visual analogue scale will be used to record pain

Secondary Outcome Measures

Name	Time	Method
Radiographic Evaluation	6, 12 and 18 months postoperatively	* No evident radiographic periapical or furcal pathosis; * No evident root resorption; * Normal lamina dura
Clinical Evaluation	3, 6, 12 and 18 months postoperatively	* Absence of pain or discomfort; * Tooth is functional, with no tenderness to palpation or percussion; * Normal mobility and probing depth; * Soft tissues surrounding the tooth are normal, with no swelling or inflammation