Three Techniques in Bioceramic Apexification for Necrotic Immature Incisors

NCT ID: NCT06119477

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-05
• Study Completion Date: 2025-05-20

Brief Summary

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.

Conditions

Immature Teeth; Periapical Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bioceramic Putty Apical Plugs

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.

Group Type: EXPERIMENTAL

Bioceramic Putty Apical Plugs

Intervention Type: OTHER

Under local anesthesia and rubber dam isolation, the canal orifice will be prepared gently. The working length and apex diameter value will be recorded as a reference. Afterward, shaping and debridement the root canals will be achieved by gentle instrumentation. The canal will be irrigated copiously with NaOCl, then dried, and filled with Ca(OH)2 dressing. Afterward, the incisor will be temporarily restored. After 14 days the temporary filling and Ca(OH)2 will be removed. Afterward, canals will be irrigated with NaOCl and EDTA and dried. 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. The correct placement and thickness of the apical plug will be verified with a periapical radiograph. Afterward, the remainder of the root canal will be filled with gutta-percha with sealer. Finally, a suitable immediate final restoration was made for each case individually.

Single Cone Gutta-percha with Bioceramic Sealer

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.

Group Type: EXPERIMENTAL

Single Cone Gutta-percha with Bioceramic Sealer

Intervention Type: OTHER

Under local anesthesia and rubber dam isolation, the canal orifice will be prepared gently. The working length and apex diameter value will be recorded as a reference. Afterward, shaping and debridement the root canals will be achieved by gentle instrumentation. The canal will be irrigated copiously with NaOCl, dried, filled with Ca(OH)2 dressing and temporarily restored. After 14 days the temporary filling and Ca(OH)2 will be removed. Afterward, canals will be irrigated with NaOCl and EDTA and dried. A large sized gutta-percha cone (GC) will be inserted to the working length, The GC was ensured to make tag-back with the apical third of the immature canal and confirmed with a periapical radiograph. Then the immature canal will be gently filled with Bioceramic sealer and the GC will be placed again and another apical radiograph will be taken to confirm that the canal was properly filled. Finally, a suitable immediate final restoration was made for each case individually.

Combination of Bioceramic Putty and Sealer

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.

Group Type: EXPERIMENTAL

Combination of Bioceramic Putty and Sealer

Intervention Type: OTHER

Under local anesthesia and rubber dam isolation, the canal orifice will be prepared gently. The working length and apex diameter value will be recorded as a reference. Afterward, shaping and debridement the root canals will be achieved by gentle instrumentation. The canal will be irrigated copiously with NaOCl, dried, filled with Ca(OH)2 dressing and temporarily restored. After 14 days the temporary filling and Ca(OH)2 will be removed. Afterward, canals will be irrigated with NaOCl and EDTA and dried.

The immature canal will be gently filled with Bioceramic sealer and then 3 to 5 small balls of BP (diameter of 1 mm) will be inserted into the canal orifice and gently plugged with hand pluggers. Afterward, an apical radiograph will be taken to confirm that the canal was properly filled without gaps and voids. Finally, a suitable immediate final restoration was made for each case individually.

Interventions

Bioceramic Putty Apical Plugs

Under local anesthesia and rubber dam isolation, the canal orifice will be prepared gently. The working length and apex diameter value will be recorded as a reference. Afterward, shaping and debridement the root canals will be achieved by gentle instrumentation. The canal will be irrigated copiously with NaOCl, then dried, and filled with Ca(OH)2 dressing. Afterward, the incisor will be temporarily restored. After 14 days the temporary filling and Ca(OH)2 will be removed. Afterward, canals will be irrigated with NaOCl and EDTA and dried. 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. The correct placement and thickness of the apical plug will be verified with a periapical radiograph. Afterward, the remainder of the root canal will be filled with gutta-percha with sealer. Finally, a suitable immediate final restoration was made for each case individually.

Intervention Type: OTHER

Single Cone Gutta-percha with Bioceramic Sealer

Under local anesthesia and rubber dam isolation, the canal orifice will be prepared gently. The working length and apex diameter value will be recorded as a reference. Afterward, shaping and debridement the root canals will be achieved by gentle instrumentation. The canal will be irrigated copiously with NaOCl, dried, filled with Ca(OH)2 dressing and temporarily restored. After 14 days the temporary filling and Ca(OH)2 will be removed. Afterward, canals will be irrigated with NaOCl and EDTA and dried. A large sized gutta-percha cone (GC) will be inserted to the working length, The GC was ensured to make tag-back with the apical third of the immature canal and confirmed with a periapical radiograph. Then the immature canal will be gently filled with Bioceramic sealer and the GC will be placed again and another apical radiograph will be taken to confirm that the canal was properly filled. Finally, a suitable immediate final restoration was made for each case individually.

Intervention Type: OTHER

Combination of Bioceramic Putty and Sealer

Under local anesthesia and rubber dam isolation, the canal orifice will be prepared gently. The working length and apex diameter value will be recorded as a reference. Afterward, shaping and debridement the root canals will be achieved by gentle instrumentation. The canal will be irrigated copiously with NaOCl, dried, filled with Ca(OH)2 dressing and temporarily restored. After 14 days the temporary filling and Ca(OH)2 will be removed. Afterward, canals will be irrigated with NaOCl and EDTA and dried.

The immature canal will be gently filled with Bioceramic sealer and then 3 to 5 small balls of BP (diameter of 1 mm) will be inserted into the canal orifice and gently plugged with hand pluggers. Afterward, an apical radiograph will be taken to confirm that the canal was properly filled without gaps and voids. Finally, a suitable immediate final restoration was made for each case individually.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Osama Aljabban, Proffesor

Role: STUDY_DIRECTOR

Damascus University

Locations

Damascus University

Damascus, , Syria

Countries

Syria

References

Tolibah YA, Kouchaji C, Lazkani T, Ahmad IA, Baghdadi ZD. Comparison of MTA versus Biodentine in Apexification Procedure for Nonvital Immature First Permanent Molars: A Randomized Clinical Trial. Children (Basel). 2022 Mar 14;9(3):410. doi: 10.3390/children9030410.

Reference Type: BACKGROUND

PMID: 35327782 (View on PubMed)

Other Identifiers

UDDS-Pedo-06-2023

Identifier Type: -

Identifier Source: org_study_id