Three Techniques in Bioceramic Apexification for Necrotic Immature Incisors

Damascus University

Status: Enrolling

Conditions: Periapical Lesion; Immature Teeth

Treatments: Other: Bioceramic Putty Apical Plugs; Other: Combination of Bioceramic Putty and Sealer; Other: Single Cone Gutta-percha with Bioceramic Sealer

Study type: Interventional

Funder types: Other

Identifiers

NCT06119477

UDDS-Pedo-06-2023

Details and patient eligibility

About

The goal of this randomized clinical trial is to find the most effective Bioceramic-based apexification procedures in children with immature necrotic maxillary incisors. The main questions they aims to answer are:

• What is the best Bioceramic apexification technique regarding the post-operative pain and the periapical healing ?
• What is the best Bioceramic apexification technique regarding the bioceramics extrusion and the required time ? Participants will under gone Bioceramic apexification procedures which root canal preparing, disinfecting, filling, and restoring. Then, the patient will asked to come to follow-up appointments for clinical and radiological evaluations If there is a comparison group: Researchers will compare Bioceramic Putty Apical Plugs, Single Cone Gutta-percha with Bioceramic Sealer, and Combination of Bioceramic putty and sealer technique to find the best effective technique.

Enrollment: 45 estimated patients

Sex: All

Ages: 7 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with one or more maxillary incisors with an open apex root (defined as root which root canal size equal or larger than #80 K-file) and presented with pulp necrosis and radiographic evidence of chronic apical periodontitis and periapical radiolucency greater than 3 mm.

Exclusion criteria

• Children with systemic diseases that compromised their general immune status.
• Uncooperative (definitely negative on the Frankl's behavioral scale).
• unrestorable incisors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Bioceramic Putty Apical Plugs

Experimental group

Description:

The Bioceramic Putty will be inserted in the apical 4 mm of the canal using the modified cannula and adapted to the canal walls with a hand plugger.

Treatment:

Other: Bioceramic Putty Apical Plugs

Single Cone Gutta-percha with Bioceramic Sealer

Experimental group

Description:

A large sized (#80 - #120, and a taper of 2%) gutta-percha cone (GC) will be inserted, measuring according to the width of the canal, to the working length, then the immature canal will be gently filled with Bioceramic sealer and the GC.

Treatment:

Other: Single Cone Gutta-percha with Bioceramic Sealer

Combination of Bioceramic Putty and Sealer

Experimental group

Description:

The immature canal will be gently filled with Bioceramic sealer and then 3 to 5 small balls of BP will be inserted into the canal orifice and gently plugged with hand pluggers.

Treatment:

Other: Combination of Bioceramic Putty and Sealer