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Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth

Comparative Evaluation of Premixed Bioceramic Putty Versus MTA as Apical Plugs in Nonvital Immature Anterior Teeth: A Clinical Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06322979
Enrollment
50
Registered
2024-03-21
Start date
2023-11-22
Completion date
2024-12-05
Last updated
2025-04-18

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

Conditions

Periapical Periodontitis

Keywords

immature teeth, apexification, apical plug

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.

Interventions

PROCEDUREMineral trioxide aggregate

Apexification treatment was done with mineral trioxide aggregate

Apexification treatment was done with Premixed Bioceramic Putty (Well-Root™ PT)

Sponsors

Tanta University
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)up to 12 monthsThe apexification procedure will be recorded as a clinical success if the tooth fulfils the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)at 6 and12 months follow upThe apexification procedure will be recorded to be radiographically successful if it demonstrates the following criteria: (1) reduction of apical lesion size (2) Normal periodontal ligament space (2) No furcation pathosis, and (3) No external resorption. The apexification procedure will be radiographically unsuccessful if the apical lesion size increases. The apexification procedure will be doubtful if the apical lesion size doesn't change

Secondary

MeasureTime frameDescription
Change in the periapical index (PAI)at 6 and12 months follow upRadio-graphically, the periapical index provides an ordinal scale of 5 scores ranging from ''healthy'' to ''severe periodontitis with exacerbating features''. (1) Normal periapical structures. (2) Small changes in bone structure. (3) Changes in bone structure with some diffuse mineral loss. (4) Periodontitis with well-defined radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).

Countries

Egypt

Outcome results

None listed

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