Bioceramic Repair Materials in Apexogenesis of Immature Permanent Molars

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.

• Bioceramic Repair Pulpotomy (BIO-C® REPAIR) (Procedure): 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).
• Mineral Trioxide Aggregate Pulpotomy (Biofactor MTA) (Procedure): 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).

Primary outcomes

• Clinical Success Rate [Evaluated at 6, 9, and 12 months post-operative.]: 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.
• Radiographic Success Rate [Evaluated at 6, 9, and 12 months post-operative.]: 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.

Secondary outcomes

• Quantitative Root Length Increase (CBCT) [Measured at Baseline (immediate post-op) and 12 months post-operative.]: 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.
• Apical Foramen Diameter Reduction / Closure (CBCT) [Measured at Baseline (immediate post-op) and 12 months post-operative.]: 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.

Sex: All, ages: 6 Years to 8 Years

Inclusion Criteria:

* Bilateral deep carious immature permanent first molars indicated for vital pulp therapy
* Vital teeth with no clinical signs or symptoms of irreversible pulpitis or pulp necrosis (Absence of spontaneous pain, tenderness to percussion or palpation, abnormal mobility and/ or soft tissue swelling, sinus tract, or fistula.)
* Teeth with restorable crowns.
* Hemostasis is achievable within a clinically acceptable period following pulp exposure.
* Absence of internal or external root resorption.
* Absence of periapical or furcal radiolucency.
* Absence of widening of the periodontal ligament space.
* Absence of pulp canal obliteration (calcification).
* Absence of ankylosis.
* Normally surrounding alveolar bone and supporting periodontal structures.

Exclusion Criteria:

* presence of internal or external root resorption
* presence of periapical or furcal radiolucency.
* presence of widening of the periodontal ligament space

• Results publication: 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. PMID 29681479
• Results publication: 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. PMID 34780875