NCT06119477

Three Techniques in Bioceramic Apexification for Necrotic Immature Incisors

Comparison of Three Techniques in Bioceramic Apexification Procedure for Necrotic Immature Incisors: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.
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.

Timeline

• Start date: 2023-05-05
• Primary completion: 2024-08-22
• Completion: 2025-05-20
• First posted: 2023-11-07
• Last updated: 2025-08-24

Locations

1 site across 1 country: Syria