Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure (PULPOTOMY)

Jordan University of Science and Technology

Status: Completed

Conditions: Pulpotomy

Treatments: Other: calcium silicate based material,

Study type: Interventional

Funder types: Other

Identifiers

NCT03522051

JUST14-4-2018

Details and patient eligibility

About

Many deep carious teeth are treated unnecessarily by root canal therapy, while with using current techniques and advances in compatible dental materials in addition to better understanding of biological response of the dental pulp, many can be treated conservatively via vital pulp therapy procedures.

Full description

Vital pulp therapy is recommended for teeth diagnosed with reversible pulpitis or partially inflamed pulps in which the remaining healthy tissue can be conserved and protected by a biologically active material to generate a hard tissue barrier that seals and protects the pulp from future microbial insult.

The aim of this in vivo study is to clinically and radiographically assess the outcome of full pulpotomy using a calcium silicate based material (NeoMTA Plus) in permanent teeth with carious exposure.

Ethics approval was obtained from the institutional ethics and research committee, and the patients were informed about details of the treatment and the possible complications. An informed consent was obtained. 120 patients meeting the inclusion criteria will be selected for this study and they will be subsequently followed up clinically and radiographically after 3 months, 6 months, 1 year and yearly afterward for 5 years.

Enrollment: 109 patients

Sex: All

Ages: 7 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Permanent teeth with mature or immature apices
• Have no significant medical problems
• The tooth should give positive response to cold test and electric pulp test (EPT)
• Probing pocket depth and mobility within normal limits
• No Signs of pulp necrosis including sinus tract or swelling
• Radiographically ; caries either exposing the pulps or reaching more than 2\3 the distance from the dentino-enamel junction (DEJ) to the pulp
• The tooth can be restored via direct restoration

Exclusion criteria

• Medically compromised patients
• Negative response to cold test
• Mobility
• Sinus tract
• Swelling
• Non restorable teeth or badly broken teeth

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

Patients with carious teeth

Experimental group

Description:

female or male patients with permanent teeth and deep caries will receive pulpotomy treatment and dressing with calcium silicate based material (Neo MTA plus material) followed by restoration.

Treatment:

Other: calcium silicate based material,