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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03522051
Acronym
PULPOTOMY
Enrollment
109
Registered
2018-05-11
Start date
2016-12-01
Completion date
2021-08-20
Last updated
2021-09-16

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

Conditions

Pulpotomy

Keywords

teeth, pulpitis, deep caries, pulpotomy, Mineral Trioxide Aggregate (MTA)

Brief summary

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.

Detailed 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.

Interventions

OTHERcalcium silicate based material,

Its a dental pulp capping material which is biocompatable and induces hard tissue barrier formation

Sponsors

Jordan University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients with symptomatic deep caries in a permanent molar tooth will receive pulpotomy treatment and placement of a calcium silicate based material (Neo MTA plus) over the pulp and followed by restoration.

Eligibility

Sex/Gender
ALL
Age
7 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain symptoms2-3 days after the treatment, 3 months, 6 months and 12 months and afterwards up to 5 years.The patient is anticipated to report reduction in the pain score after receiving the treatment within 2-3 days and the tooth should continue to be asymptomatic at follow up appointments. The patient will be asked to score the pain level on visual analogue scale using a score from 0-10. The zero is no pain while 10 is the maximum level.

Secondary

MeasureTime frameDescription
Periapical normalcy at follow up radiographs .6months , 1 year, 2, 3,4,5 yearsPr-existing pathology should heal within 6 months- 1 year and normalcy should be maintained after ward up to 5 years. no emerging pathosis should be evident in the roots or surrounding bone.
The tooth and restoration should be present in the mouth3, 6 months, 1 year, 2, 3,4,5 yearsThe tooth should be in the mouth and in function (not extracted) with an intact restoration at the follow up times

Countries

Jordan

Outcome results

None listed

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