None listed
Conditions
Brief summary
Dental pulp becomes infected due to caries or trauma, especially in children due to a lack of health awareness, oral care and a sugary-based diet. Therefore, maintaining the proper pulp or performing the appropriate pulp treatment is necessary to maintain tooth function. Infected Dental pulp in immature teeth impairs root growth and makes the tooth prone to fracture and thus its loss, so research and studies have continued to find the appropriate way to complete root growth and apex closure in a process called Apexogenisis or at least Apexification. Apexification is a method for treating immature permanent teeth that have stopped their roots developing due to necrotic pulp. Several bio-materials appeared that seal the uncompleted apex and achieved good clinical success. (MTA) was considered the material chosen since 1993 to form an apical plug due to its biological properties in addition to achieving the appropriate sealing, but it has disadvantages, like long setting time, difficulties in application, and possible coronal contamination associated with the MTA led to begin studying other alternative materials In 2009, Biodentine (Septodont, St Maur des Fosses, France) was given, made of Tri-Calcium Silicate cement. Biodentine is easy to apply due to its excellent viscosity and short setting time, which is about 12 minutes. There are not enough recent studies to influence the use of this substance in adolescents on the healing of apical lesions in young permanent teeth and their comparison with the MTA applied in two sessions. Based on these data, the idea of this research comes to evaluate the clinical and radiological performance of Biodentine compared to the MTA in treating apical lesions of immature permanent molar.
Interventions
Following the randomization procedure, patients will be assigned sequential numbers in the order of enrolment. Group I will include 12 immature molars treated with MTA (White ProRoot MTA, Dentsply, Tulsa, OK, USA) as apical plug, whereas group II will include 12 teeth treated with Biodentine (Septodont, Saint-Maur-des-Fosses, France) as apical plug. All the apexification treatments will be performed by the researcher. Under local anesthesia and rubber dam isolation, all superficial caries will be removed with carbide fissure bur mounted on a low-speed hand-piece. Access cavity will be prepared using an endo-z bur mounted on high-speed hand-piece, and the cavity will be rinsed with 2.5% NaOCl. Working length will be calculated radiographically with K-files (Mani, INK, Japan) and recorded as reference. root canals will be instrumented gently with Fanta AF3 (Fanta Dental Materials Co., LTD, Shanghai, China) and copious irrigation with 1.3% sodium hypochlorite (NaOCI) (Merck, Darmstadt, Germany) by means of a 30- gauge endodontic irrigating needle (Sybron Endo, Crop, Orange, CA, USA). As final irrigation all canals will be filled up with NaOCl 1.3% and activated with #40 U-file ultrasonic tip (Zipperer Co., Munchen, Germany) for 30 seconds for each canal, then all canals will be irrigated with normal saline, then all canals will be filled up with Q-mix (Dentsply Tulsa Dental, Tulsa, OK, USA) and activated with #40 U-file ultrasonic tip (Zipperer Co., Munchen, Germany) for 10 seconds. After drying with large sterile paper points apical plug will be done according to randomization MTA with 2 visits or Biodentine with one visit. Biodentine plug Group (performed in a single clinic visit of approximately 45 minutes): Biodentine will be placed with MAP-One System (Produits Dentaires, sa vevey, switzerland) into the apical portion of canals with about 4 mm thickness and adapted to the canal walls with an endodontic hand plugger (Dentsply, Tulsa, OK, USA). Correct placement of the Biodentine plugs will be verified with a radiograph. After 12 min the setting of Biodentine will be detected gently with #40 k-file (Mani, INK, Japan). The coronal and middle third of the root canal will be filled with gutta-percha in conjunction with AH Plus sealer (Dentsply Sirona Endodontics) using lateral condensation technique. The coronal restoration will be completed with GIC Fuji IX (GC Corporation, Tokyo, Jappan), then bonded resin composite (3M ESPE, Dental Products, St. Paul, MN, USA), and stainless steel crown (3M ESPE, Dental Products, St. Paul, MN, USA). Patients of both groups will be recalled for radiographical examinations after the end of treatment at 1, 3, 6 and 12 months. Periapical radiographs will be taken using a paralleling technique with a film holder (Hawe Super-Bite; Kerr Hawe SA, Bioggio, Switzerland) by a digital radiographic system at every recall visits. All digital radiographs will be obtained under standard exposure conditions (60 kVp, 7 mA and 0.32 s) using a dental X-ray machine (Gendex GX, Lake Zurich, IL, USA).The radiographic assessment will be done with two pre-trained independent investigators. Each investigator will determine the size of apical lesion using “Image J” program and scored the sizes in both groups blindly and independently and will repeat the radiographic scoring after 1 month to assess the intraobserver reliability. Any disagreement on apical lesion size for a particular root resulted in joint evaluation until agreement will be reached.
Sponsors
Study design
Eligibility
Inclusion criteria
The inclusion criteria will be as the following: cooperative children without any systemic disease or compromised immune status, and who had a first immature mandibular molar with at least one canal sized #60 and more and had an apical lesion.
Exclusion criteria
The exclusion criteria will be patients with advanced periodontitis (more than 5 mm periodontal attachment and bone loss), molars that cannot be restored (root fracture, unrestorable tooth, massive internal or external), and molars that had previous endodontic treatment.