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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06637761
Enrollment
22
Registered
2024-10-15
Start date
2024-10-05
Completion date
2025-12-30
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mineral Trioxide Aggregate

Keywords

bioactive bioceramic, discoloration, revascularization, mineral trioxide aggregate

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.

Interventions

DRUGNeoMTA2

Bio-active bio-ceramic mineral trioxide aggregate

DRUGWMTA

White Mineral trioxide aggregates

Sponsors

Misr University for Science and Technology
CollaboratorOTHER
Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Discoloration1 yearUsing shade guide (VITA classical)

Other

MeasureTime frameDescription
swelling1 yearClinical examination (Visual examination and palpation of the labial vestibule and the palatal area related to every affected tooth)

Contacts

Primary ContactOla Mourad, Msc
ola.abdelkader@dentistry.cu.edu.eg01062952921

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026