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

Tanta University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Periapical Periodontitis

Interventions

Eligibility

Sex: ALLMin age: 8 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)

The 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.

Time frame: up to 12 months

the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)

The 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

Time frame: at 6 and12 months follow up

Secondary Outcomes

Change in the periapical index (PAI)

Radio-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).