Clinical & Radiographic Evaluation of Neo MTA Versus White MTA in Revascularization of Non-Vital Immature Permanent Teeth

NCT ID: NCT03545139

Last Updated: 2020-02-20

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

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-09-30

Brief Summary

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* To evaluate and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.
* Evaluation of the effectiveness of Neo MTA as coronal plug in revascularization of immature teeth with necrotic pulp.

Detailed Description

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The new formulation of MTA (NeoMTA) does not contain bismuth oxide, will be used in revascularization of nonvital immature permanent anterior teeth.

to evaluate the effectiveness of Neo MTA as coronal plug and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.

Conditions

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Nonvital Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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NeoMTA (intervention group)

Revascularization with NeoMTA as coronal plug.

Group Type EXPERIMENTAL

NeoMTA nusmile

Intervention Type BIOLOGICAL

A new formulation of MTA was developed in which bismuth oxide was omitted.

White MTA (Control group)

Revascularization with Conventional white mineral trioxide aggregate (White MTA) as coronal plug.

Group Type ACTIVE_COMPARATOR

White MTA

Intervention Type BIOLOGICAL

Revascularization with Conventional white mineral trioxide aggregate as coronal plug.

Interventions

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NeoMTA nusmile

A new formulation of MTA was developed in which bismuth oxide was omitted.

Intervention Type BIOLOGICAL

White MTA

Revascularization with Conventional white mineral trioxide aggregate as coronal plug.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age of patients: 7-15years old.
* Free from any systemic diseases that may affect the normal healing process.
* Tooth with immature root apex.
* Traumatically or cariously exposed non vital permanent anterior tooth.
* Pulp space not needed for post and core for final restoration.
* Compliant patient/parent

Exclusion Criteria

* Patients having allergy to medicaments and antibiotics necessary to complete procedure.
* Tooth with vital pulp or complete root formation.
* Teeth with internal or external root resorption.
* Un-cooperative patients.
* Luxative injuries.
* Teeth with a root fracture
* Alveolar fracture
* Subjects with chronic systemic illness.
* Subjects with poor oral hygiene.
* Compromised remaining tooth structure as teeth with extensive loss of coronal tissue will require restoration with a post that will occupy the space required for blood clot formation.
Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hala Ahmed Tawfik

Researcher assistant at orthodontic and pediatric dentistry department National Research centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Oral & Dental Medicine Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Hala Tawfik

Role: primary

01202555598

Other Identifiers

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NeoMTA in Revascularization

Identifier Type: -

Identifier Source: org_study_id

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