Clinical trial NCT06322979: Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth
Official title: Comparative Evaluation of Premixed Bioceramic Putty Versus MTA as Apical Plugs in Nonvital Immature Anterior Teeth: A Clinical Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periapical Periodontitis
Keywords: immature teeth
apexification
apical plug
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. After working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in MTA Group, MTA will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. Next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with GIC, composite. In the Premixed Bioceramic Putty group, Well-Root™ PT will be placed into the apical 4 mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.

children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment.


Eligibility criteria: Inclusion Criteria:

* nonvital immature permanent teeth as a consequence of trauma or dental caries
* nonvital permanent teeth with radiographic evidence of immature root end development
* clinically restorable teeth

Exclusion Criteria:

* immature nonvital permanent teeth presenting with signs/symptoms of internal/external resorption, moderate to severe mobility, periodontal bone loss
* Immature nonvital permanent teeth associated with developmental abnormalities.
* Patients with a history of systemically debilitating diseases
* unrestorable remaining crown structure

Primary outcomes:
measure: the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)
timeFrame: up to 12 months
measure: the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)
timeFrame: at 6 and12 months follow up
Secondary outcomes:
measure: Change in the periapical index (PAI)
timeFrame: at 6 and12 months follow up
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbia
Study officials:
References:
citation: Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.