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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mineral Trioxide Aggregate
• Intervention / Treatment: Drug: NeoMTA2; Drug: WMTA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ola Mourad, Msc; Phone Number: 01062952921; Email: ola.abdelkader@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; NeoMTA 2 Manipulation and mixing will be done according to manufacturer instructions: 1 scoop (0.1gm) of NeoMTA 2 Powder will be dispensed on a glass slab. Then two drops of NeoMTA 2 Gel will be dispensed next to the powder.; Gradually as much Gel as necessary will be added to the Powder to achieve the desired consistency. The Gel will be incorporated by spatula-ting the Powder/Gel mixture firmly against the glass slab to ensure all of the Powder is thoroughly witted by the Gel.	Drug: NeoMTA2; Bio-active bio-ceramic mineral trioxide aggregate; Other Names: Nu smile,USA
Active Comparator: Group II; White mineral trioxide aggregate; One spoon of powder and one drop of distilled water are dispensed on a sterile glass slab.; A metal spatula will be used to gradually mix the liquid and powder together for 30 seconds to ensure full wetting of the powder particles and to obtain a consistency similar to wet sand.; 3-4 mm of white MTA will be placed over the clot carefully by using an amalgam carrier. The mix will be placed over the collagen matrix 2mm beneath the clinical cement-enamel junction.	Drug: WMTA; White Mineral trioxide aggregates; Other Names: Angulus, Brazil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discoloration	Using shade guide (VITA classical)	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
swelling	Clinical examination (Visual examination and palpation of the labial vestibule and the palatal area related to every affected tooth)	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Misr University for Science and Technology
• Investigators: Study Director: Youssef, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): October 5, 2024
• Primary Completion (Estimated): October 6, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: revascularization; mineral trioxide aggregate; discoloration; bioactive bioceramic
• Other Study ID Numbers: Cairo U Clinical

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes