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

NCT ID: NCT06637761

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-05
• Study Completion Date: 2025-12-30

Brief Summary

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.

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.

Conditions

Mineral Trioxide Aggregate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

NeoMTA2

Intervention Type: DRUG

Bio-active bio-ceramic mineral trioxide aggregate

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.

Group Type: ACTIVE_COMPARATOR

WMTA

Intervention Type: DRUG

White Mineral trioxide aggregates

Interventions

NeoMTA2

Bio-active bio-ceramic mineral trioxide aggregate

Intervention Type: DRUG

WMTA

White Mineral trioxide aggregates

Intervention Type: DRUG

Other Intervention Names

Nu smile,USA; Angulus, Brazil

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Misr University for Science and Technology

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ola mourad

Assisstant lecturer in pediatric dentistry department, faculty of dentistry, Misr University for sience and technology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Youssef

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

Ola Mourad, Msc

Role: CONTACT

ola.abdelkader@dentistry.cu.edu.eg

01062952921

Other Identifiers

Cairo U Clinical

Identifier Type: -

Identifier Source: org_study_id