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

NCT ID: NCT03522051

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2021-08-20

Brief Summary

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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

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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.

Conditions

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Pulpotomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with carious teeth

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.

Group Type EXPERIMENTAL

calcium silicate based material,

Intervention Type OTHER

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

Interventions

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calcium silicate based material,

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

Intervention Type OTHER

Other Intervention Names

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Neo MTA plus, Avalon Biomed

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jordan University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nessrin A Taha, PhD

Role: STUDY_DIRECTOR

Jordan University of Science and Technology

Locations

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Jordan University of science and technology

Irbid, , Jordan

Site Status

Countries

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Jordan

References

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Taha NA, Abdelkhader SZ. Outcome of full pulpotomy using Biodentine in adult patients with symptoms indicative of irreversible pulpitis. Int Endod J. 2018 Aug;51(8):819-828. doi: 10.1111/iej.12903. Epub 2018 Feb 27.

Reference Type BACKGROUND
PMID: 29397003 (View on PubMed)

Taha NA, Khazali MA. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2017 Sep;43(9):1417-1421. doi: 10.1016/j.joen.2017.03.033. Epub 2017 Jun 30.

Reference Type BACKGROUND
PMID: 28673494 (View on PubMed)

Taha NA, Ahmad MB, Ghanim A. Assessment of Mineral Trioxide Aggregate pulpotomy in mature permanent teeth with carious exposures. Int Endod J. 2017 Feb;50(2):117-125. doi: 10.1111/iej.12605. Epub 2016 Jan 30.

Reference Type BACKGROUND
PMID: 26715408 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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JUST14-4-2018

Identifier Type: -

Identifier Source: org_study_id

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