Clinical trial NCT06637761: Clinical and Radio-graphic Evaluation of Non-staining Bio-active Bio-ceramic (Neo MTA 2) in Revascularization
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Mineral Trioxide Aggregate
Keywords: bioactive bioceramic
discoloration
revascularization
mineral trioxide aggregate
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Misr University for Science and Technology
First posted: 2024-10-15
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Discoloration
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: swelling
timeFrame: 1 year
Locations:
Study officials:
affiliation: Cairo University
name: Youssef
role: STUDY_DIRECTOR
References: