An interventional study of Bioceramic apical plug and Regenerative endodontic procedure in Periapical Diseases, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
Recent advancements in dentistry are driven by the development of dental materials and therapies that support tissue regeneration, including the application of bioactive, biocompatible calcium silicate-based materials like mineral trioxide aggregate (MTA), Biodentine, and bioceramic sealers/putties, which facilitated the integration of different treatment protocols. These root canal treatment protocols can be implemented in the same tooth based on the specific stage of root development, such as combining conventional root canal treatment in the root with a closed mature apex, and regeneration or apical plug in the root with an open immature apex, thereby gaining the benefits of each protocol with a minimally invasive, more conservative approach. No research studies have been published evaluating the effect of combined different root canal treatment protocols on the management of molars with coexistent mature and immature apices. This study will evaluate the outcomes of combined root canal therapies in mandibular molars with coexistent mature and immature apices.
46 studies on the registry are indexed under Periapical Diseases; 11 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 37 interventional studies indexed under Periapical Diseases.
Browse Periapical Diseases studies →Al-Azhar University is the lead sponsor of 525 studies on the registry; 171 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Mandibular molars with a mature mesial root and an immature distal root, treated in two visits: a bioceramic apical plug in the immature distal root and conventional root canal treatment in the mature mesial root.
Procedure: Bioceramic apical plug
Mandibular molars with a mature mesial root and an immature distal root, treated in two visits: a regenerative endodontic procedure in the immature distal root and conventional root canal treatment in the mature mesial root.
Procedure: Regenerative endodontic procedure
Two-visit treatment of mandibular molars with a mature mesial root and an immature distal root. After chemomechanical preparation (ProTaper Next; 2.5% sodium hypochlorite (NaOCl); final irrigation with 1.5% NaOCl, saline and 17% ethylenediaminetetraacetic acid (EDTA) with sonic activation), a 3 to 4 millimeter (mm) apical plug of bioceramic putty (Bio-C Repair, Angelus) is placed in the immature distal root using the Micro-Apical Placement (MAP) One system. At the second visit, the mature mesial canals are obturated with gutta-percha and a bioceramic sealer (Bio-C Sealer) using warm vertical compaction, and the tooth is restored with composite resin.
Two-visit treatment of mandibular molars with a mature mesial root and an immature distal root. Visit 1: gentle irrigation of the immature distal canal with 1.5% sodium hypochlorite (NaOCl) and saline, then calcium hydroxide intracanal medication (Metapaste) for 2 weeks. Visit 2 (local anesthesia without vasoconstrictor): irrigation with saline and 17% ethylenediaminetetraacetic acid (EDTA), bleeding induced with a precurved size 25 K-file about 2 millimeters (mm) beyond the apex to form an intracanal blood clot, then a coronal barrier of bioceramic putty placed with the Micro-Apical Placement (MAP) One system and covered with glass ionomer. The mature mesial canals are obturated with gutta-percha and a bioceramic sealer using warm vertical compaction, and the tooth is restored with composite resin.
Periapical healing assessed by the Periapical Index (PAI)
Periapical status of the treated tooth scored with the Periapical Index (PAI) on digital periapical radiographs at 3, 6 and 12 months, and on cone-beam computed tomography (CBCT) at 12 months. Lower scores indicate healthier periapical status. Reported as the number (%) of teeth in each PAI score category.
Time frame: Baseline, 3, 6 and 12 months after treatment
Tenderness to percussion
Number (%) of teeth with tenderness to percussion. Each tooth was percussed three times on the cusps with the shaft of a straight probe and scored as negative (no pain or discomfort) or positive (pain or discomfort compared with adjacent and contralateral teeth).
Time frame: 3, 6 and 12 months after treatment
Tenderness to palpation
Number (%) of teeth with tenderness to palpation, assessed by firm digital pressure over the buccal and lingual cortical plates at the root apices and scored as negative (no tenderness) or positive (tenderness or pain).
Time frame: 3, 6 and 12 months after treatment
Presence of a sinus tract
Number (%) of teeth with a sinus tract present on clinical examination.
Time frame: 3 and 12 months after treatment
Increased tooth mobility
Number (%) of teeth with increased tooth mobility, graded with Miller's classification (grade 0, physiological; grade 1, slight; grade 2, moderate; grade 3, severe).
Time frame: 12 months after treatment
Postoperative pain intensity
Pain intensity self-reported by patients on a modified Verbal Descriptor Scale (VDS) from 0 (no pain) to 10 (worst pain), using an Arabic-language form.
Time frame: 24, 48, 72, 96 and 120 hours after treatment
Postoperative swelling
Swelling self-reported by patients on a four-point scale: 0 = none, 1 = mild intraoral swelling, 2 = moderate localized facial swelling, 3 = severe diffuse facial swelling.
Time frame: 24, 48, 72, 96 and 120 hours after treatment
Pattern of radiographic response of the immature distal root
Radiographic response classified according to Chen et al.: type I, continued root maturation with canal wall thickening; type II, apex becomes blunt and closed without further root development; type III, continued root development with an open apex; type IV, severe canal calcification; type V, hard-tissue barrier formed in the canal. Reported as the number (%) of teeth of each type.
Time frame: 12 months after treatment
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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