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

February 19, 2020 updated by: Hala Ahmed Tawfik, Cairo University

Clinical and Radiographic Evaluation of Neo MTA Versus Conventional White MTA in Revascularization of Non-Vital Immature Permanent Anterior Teeth: A Randomized Controlled Trial

  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of oral & dental medicine Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NeoMTA (intervention group)
Revascularization with NeoMTA as coronal plug.
Biological: NeoMTA nusmile
A new formulation of MTA was developed in which bismuth oxide was omitted.
Active Comparator: White MTA (Control group)
Revascularization with Conventional white mineral trioxide aggregate (White MTA) as coronal plug.
Biological: White MTA
Revascularization with Conventional white mineral trioxide aggregate as coronal plug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discoloration/ Staining potential
Time Frame: 9 month
Using spectrophotometer by operator
9 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on biting
Time Frame: 9 month
Verbal questioning of the patient
9 month
Pain on percussion
Time Frame: 9 month
Using back of the mirror
9 month
Sinus or fistula, recurrent swelling
Time Frame: 9 month
Visual examination by operator
9 month
Root lengthening
Time Frame: 9 month
Radiographic Digora image analysis software i.e. Digora for windows software DFW
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

June 4, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeoMTA in Revascularization

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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