An interventional study of Bioceramic Repair Pulpotomy (BIO-C® REPAIR) and Mineral Trioxide Aggregate Pulpotomy (Biofactor MTA) in Apexogenesis, Pulp Exposure, Dental and MTA Vital Tooth Pulpotomy, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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.
Preservation of pulp vitality in immature permanent teeth is essential for continued root development and physiological apical closure. Apexogenesis is a conservative vital pulp therapy procedure that maintains the vitality of the radicular pulp, allowing continued root maturation, dentinal wall thickening, and strengthening of the tooth structure.
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.
Thirty children aged 6-8 years presenting with bilateral deep carious lesions in immature permanent first molars requiring vital pulp therapy were enrolled in this split-mouth randomized clinical trial after obtaining informed parental consent. Only restorable teeth with vital pulps, no clinical signs or symptoms of irreversible pulp degeneration, and the ability to achieve hemostasis within a clinically acceptable period following pulp exposure were included.
Clinical and radiographic evaluations were performed at 6, 9, and 12 months postoperatively, while CBCT examinations were conducted before treatment and after 12 months to quantitatively assess root length, apical foramen diameter, and periapical bone density using region of interest (ROI) measurements.
31 studies on the registry are indexed under Dental Pulp Exposure; 6 are open to participants now.
This study's enrollment of 30 is below the median of 53 across 29 interventional studies indexed under Dental Pulp Exposure.
Browse Dental Pulp Exposure studies →Tanta University is the lead sponsor of 991 studies on the registry; 316 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Immature permanent first molars with vital exposed pulp undergoing apexogenesis (deep pulpotomy) using a ready-to-use premixed bioceramic repair material (BIO-C® REPAIR).
Procedure: Bioceramic Repair Pulpotomy (BIO-C® REPAIR)
Immature permanent first molars with vital exposed pulp undergoing apexogenesis (deep pulpotomy) using a powder-liquid mineral trioxide aggregate (Biofactor MTA).
Procedure: Mineral Trioxide Aggregate Pulpotomy (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).
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).
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.
Time frame: 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.
Time frame: Evaluated at 6, 9, and 12 months post-operative.
Quantitative Root Length Increase (CBCT)
Root length measured in millimeters ($\\text{mm}$) on sagittal Cone-Beam Computed Tomography (CBCT) sections. Measured from the cemento-enamel junction (CEJ, fixed reference point) to the most apical point of the root using OnDemand3D™ software. Maturogenesis/continued root lengthening is calculated as the net difference between baseline (immediate post-op) and 12-month follow-up scans.
Time frame: Measured at Baseline (immediate post-op) and 12 months post-operative.
Apical Foramen Diameter Reduction / Closure (CBCT)
Apical foramen diameter measured in millimeters on sagittal CBCT sections at the widest dimensions of the open apex using OnDemand3D™ software. Progressive apical closure/apexogenesis is calculated as the net reduction in apical foramen diameter between baseline (immediate post-op) and 12-month follow-up scans.
Time frame: Measured at Baseline (immediate post-op) and 12 months post-operative.
Ran from May 2024 to primary completion in Aug 2025, 15 months.
Of 13 interventional studies with no phase under Dental Pulp Exposure, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 15. This study's 15 months is close to that.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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