NCT07883239|CompletedDMC
Bioceramic Repair Materials in Apexogenesis of Immature Permanent Molars
Clinical and Radiographic Evaluation of Bioceramic Repair in Apexogenesis of Immature Permanent Molars
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Clinical and Radiographic Evaluation of Bioceramic Repair in Apexogenesis of Immature Permanent Molars
Sponsor study identifier
interventional
30
1 country
1
Study Start
May 3, 2024
Actual (reported)Primary Completion
August 5, 2025
Actual (reported)Study Completion
May 4, 2026
Actual (reported)The present study was conducted to compare the clinical, radiographic, and tomographic outcomes of apexogenesis using Bio-C Repair and Biofactor MTA in immature permanent first molars with vital asymptomatic pulp exposure.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 4, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 3, 2024
Actual (reported)August 5, 2025
Actual (reported)May 4, 2026
Actual (reported)October 13, 2026
Actual (reported)October 20, 2026
Actual (reported)Clinical Success Rate
Clinical success evaluated binary (Success/Failure) at follow-up intervals based on the total absence of clinical signs and symptoms: Absence of spontaneous or persistent pain. Absence of tenderness to percussion. Absence of gingival inflammation surrounding the treated tooth. Absence of abscess, draining sinus tract, or pathological tooth mobility.
Evaluated at 6, 9, and 12 months post-operative.
Radiographic Success Rate
Radiographic success evaluated binary (Success/Failure) via digital periapical radiographs based on standard endodontic criteria: Absence of periapical radiolucency or osteolytic lesions. Absence of internal or external root resorption. Absence of widening of the periodontal ligament space. Evidence of continued root development with progressive apical closure.
Evaluated at 6, 9, and 12 months post-operative.
Immature permanent first molars with vital exposed pulp undergoing apexogenesis (deep pulpotomy) using a ready-to-use premixed bioceramic repair material (BIO-C® REPAIR).
Immature permanent first molars with vital exposed pulp undergoing apexogenesis (deep pulpotomy) using a powder-liquid mineral trioxide aggregate (Biofactor MTA).
Pre-procedure \& Isolation: Pre-procedural 0.2% chlorhexidine mouthwash for 30 seconds; local anesthesia (4% Articaine with 1:100,000 epinephrine); rubber dam isolation. Surgical Procedure: Caries excavation and pulp chamber deroofing using a No. 330 bur; coronal pulp amputation using a sterile sharp excavator; irrigation with light saline flow; hemostasis achieved using a saline-moistened cotton pellet applied for 5 minutes. Material Placement: Ready-to-use BIO-C® REPAIR applied directly over the pulp stumps according to manufacturer instructions and adapted with a slightly moistened sterile cotton pellet. Restoration: Base layer sealed immediately with water-mixable glass ionomer cement (KROMOGLASS® 2) and restored with a nano-hybrid bulk-fill resin composite (Any-Com™ Nano Hybrid Bulk-Fill with One Coat Bond SL).
faculty of dentistry, Tanta university
Tanta, Egypt
Taha NA, Abdulkhader SZ. Full Pulpotomy with Biodentine in Symptomatic Young Permanent Teeth with Carious Exposure. J Endod. 2018 Jun;44(6):932-937. doi: 10.1016/j.joen.2018.03.003. Epub 2018 Apr 19.
Vafaei A, Nikookhesal M, Erfanparast L, Lovschall H, Ranjkesh B. Vital pulp therapy following pulpotomy in immature first permanent molars with deep caries using novel fast-setting calcium silicate cement: A retrospective clinical study. J Dent. 2022 Jan;116:103890. doi: 10.1016/j.jdent.2021.103890. Epub 2021 Nov 12.
30 participants (actual enrollment reported by the registry).
First Submitted
October 13, 2026
First Posted
October 20, 2026
Study Start
May 3, 2024
Actual (reported)Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping
Quantitative Root Length Increase (CBCT)
Measured at Baseline (immediate post-op) and 12 months post-operative.
Apical Foramen Diameter Reduction / Closure (CBCT)
Measured at Baseline (immediate post-op) and 12 months post-operative.
Pre-procedure \& Isolation: Identical pre-procedural rinse, local anesthesia administration, rubber dam isolation, caries excavation, coronal pulp amputation, saline irrigation, and 5-minute hemostasis protocol. Material Placement: Biofactor MTA powder and liquid mixed according to manufacturer instructions, applied directly over the pulp stumps, and adapted with a slightly moistened sterile cotton pellet. Restoration: Identical double-seal final restoration (glass ionomer base + nano-hybrid bulk-fill composite resin).
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Primary Completion
August 5, 2025
Actual (reported)Study Completion
May 4, 2026
Actual (reported)Last Updated
October 20, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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