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

A Comparative Study Between MTA Pulpotomy and Root Canal Treatment in Management of First Permanent Molars With Irreversible Pulpitis in Children: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06488131
Enrollment
62
Registered
2024-07-05
Start date
2024-07-31
Completion date
2025-06-30
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis

Keywords

Endodontic Treatment, Vital Pulp Therapy

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.

Interventions

PROCEDUREMTA Pulpotomy

Complete coronal MTA pulpotomy.

PROCEDURERoot Canal Treatment

Conventional root canal treatment.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain Reliefpreoperatively, 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

MeasureTime frameDescription
Clinical Evaluation3, 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
Radiographic Evaluation6, 12 and 18 months postoperatively* No evident radiographic periapical or furcal pathosis * No evident root resorption * Normal lamina dura

Contacts

Primary ContactAlaa A. Eissa, Msc
alaaeissa@dent.asu.edu.eg00201012036000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026