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

NCT06637761 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: Cairo U Clinical
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mineral Trioxide Aggregate

Keywords

bioactive bioceramic; discoloration; revascularization; mineral trioxide aggregate

Outcome Measures

Primary Outcomes (1)

• Discoloration

  Using shade guide (VITA classical)

  1 year

Other Outcomes (1)

• swelling

  1 year

Study Arms (2)

Group I

EXPERIMENTAL

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

Group II

ACTIVE COMPARATOR

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

Interventions

NeoMTA2 DRUG

Bio-active bio-ceramic mineral trioxide aggregate

Also known as: Nu smile,USA

Group I

WMTA DRUG

White Mineral trioxide aggregates

Also known as: Angulus, Brazil

Group II

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Misr University for Science and Technology: collaborator

Study Officials

• Youssef

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ola Mourad, Msc

CONTACT

01062952921; ola.abdelkader@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple(Patients, radio-graphic outcome assessor(s), and statisticians) will be blinded in this study. Blinding to participant: will not know either the intervention or the comparative will be applied to their teeth Blinding to outcome assessor: to overcome detection bias Blinding to statisticians: to overcome bias
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer in pediatric dentistry department, faculty of dentistry, Misr University for sience and technology

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 15, 2024
• Study Start: October 5, 2024
• Primary Completion: October 6, 2025
• Study Completion: December 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share