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NCT Number: NCT06637761

Clinical and Radio-graphic Evaluation of Non-staining Bio-active Bio-ceramic (Neo MTA 2) in Revascularization

The study will compare the clinical and radio-graphic performance of newly introduced non-staining bio-active bio-ceramic (Neo MTA 2) versus White MTA used as coronal plug material in revascularization of non-vital immature permanent anterior teeth.Visual examination, palpation, A measuring scale in digital radio-graph software (DIGORA for Windows software) will be used for evaluation.

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Key information

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Mineral trioxide aggregate (MTA) has been widely used in revascularization procedures for coronal sealing in more than 85% of studies for privilege of bio compatibility, good sealing properties, and marginal adaptation. However, its poor handling characteristics and potential coronal discoloration effects are the major disadvantages of using mineral trioxide aggregate.

Although white MTA (WMTA) has been developed to overcome the tooth discoloration caused by the application of grey MTA, several in vivo and in vitro studies have also reported tooth discoloration after using WMTA.

To overcome the problems associated with WMTA, a new modification was introduced to the market called NeoMTA 2 as a new hope to overcome the discoloration problem. NeoMTA 2 provides easier handling, shorter setting time, and better color. The lack of post-operative discoloration problems was mainly due to the absence of Bismuth oxide in NeoMTA.

up to date, no clinical trials have reported the clinical and radio-graphic outcomes after revascularization of non-vital immature permanent anterior teeth using Neo MTA 2. Thus, the present study aims to evaluate and compare clinically and radio-graphically the effect of using two different coronal plug materials (Neo MTA 2 versus White mineral trioxide aggregate) in revascularization of non-vital immature permanent anterior teeth.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cooperative patient/ compliant parents or guardians
  • Patients free from any systemic diseases that hinder the normal healing process according to parental history
  • Necrotic immature permanent anterior teeth
  • Enough coronal portion of teeth that does not necessitate post and core for final restoration

Exclusion criteria

  • Patients having an allergy to medicament and antibiotics necessary to complete the procedure
  • Teeth with internal or external root resorption
  • Uncooperative patients/ in-compliant parents or guardians
  • Laxative injuries
  • Avulsed tooth after re-plantation
  • Compromised remaining coronal structure

Treatment and study plan

NeoMTA2

Drug

Bio-active bio-ceramic mineral trioxide aggregate

Other names: Nu smile,USA

WMTA

Drug

White Mineral trioxide aggregates

Other names: Angulus, Brazil

Primary outcomes

  1. Discoloration

    Time frame: 1 year

    Using shade guide (VITA classical)

Other outcomes

  1. swelling

    Time frame: 1 year

    Clinical examination (Visual examination and palpation of the labial vestibule and the palatal area related to every affected tooth)

Study contacts

Contact information is provided by the study sponsor or research team.

Ola Mourad, Msc

CONTACT

[email protected]

01062952921

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Misr University for Science and Technology

Registry information

Official study title

Clinical and Radio-graphic Evaluation of Bio-active Bio-ceramic (Neo MTA 2) Versus White MTA Used as Coronal Plug Material in Revascularization of Non-vital Immature Permanent Anterior Teeth: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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