Periapical Diseases
Conditions
Brief summary
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.
Interventions
PROCEDUREBioceramic apical plug
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.
PROCEDURERegenerative endodontic procedure
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.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 6 to 16 years, of both sexes * ASA physical status I or II (American Society of Anesthesiologists classification) * Mandibular first or second permanent molar with non-vital (necrotic) pulp and two separate (non-fused) mesial and distal roots * Mature mesial root: Cvek stage V root development, apical diameter equal to or less than K-file ISO size 40, Weine type III canal configuration * Immature distal root: Cvek stage IV root development, apical diameter greater than K-file ISO size 40, Weine type I canal configuration * Restorable tooth (Class I or II of the classification of teeth with extensive endodontic damage) * Tooth mobility grade 0 or 1 (Miller classification) * Periodontal probing depth 0 to 3.5 mm (Community Periodontal Index score 0 to 2) * Periapical radiolucency 0 to 2 mm (Periapical Index score 0 to 2) * Pre-operative pain score 0 to 5 on the modified Verbal Descriptor Scale
Exclusion criteria
* ASA physical status III or IV * Uncooperative patients * Teeth with fused roots, a single root, or more than two roots * Teeth in which both the mesial and distal roots are mature, or both are immature
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periapical healing assessed by the Periapical Index (PAI) | Baseline, 3, 6 and 12 months after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tenderness to percussion | 3, 6 and 12 months after treatment | 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). |
| Tenderness to palpation | 3, 6 and 12 months after treatment | 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). |
| Presence of a sinus tract | 3 and 12 months after treatment | Number (%) of teeth with a sinus tract present on clinical examination. |
| Increased tooth mobility | 12 months after treatment | Number (%) of teeth with increased tooth mobility, graded with Miller's classification (grade 0, physiological; grade 1, slight; grade 2, moderate; grade 3, severe). |
| Postoperative pain intensity | 24, 48, 72, 96 and 120 hours after treatment | 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. |
| Postoperative swelling | 24, 48, 72, 96 and 120 hours after treatment | 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. |
| Pattern of radiographic response of the immature distal root | 12 months after treatment | 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMohamed Magdy Barakat, BDS
Al-Azhar University
Outcome results
None listed