Biodentine as an Apical Plug in Immature Permanent Molars
Condition: Periapical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional

Summary: 
      Following the randomization procedure, patients will be divided into 2 groups (12 immature
      molars in each group): Group I will be treated with MTA as apical plug, whereas group II will
      be treated with Biodentine as apical plug. After working length determination,
      instrumentation and sterilizing root canals, apical plug will be done as following:

      Biodentine Group: Biodentine will be placed into the apical portion of canals. After 12 min
      the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus.
      The coronal restoration will be completed with GIC, composite, and stainless-steel crown.

      MTA Group: MTA will be placed into the apical portion of canals, then a moist cotton pellet
      will be placed and the access cavity will be restored with temporary filling. Next day,
      temporary filling and the cotton pellet will be removed, then the coronal restoration will be
      performed as Biodentine group.

      Patients of both groups will be recalled for clinical and radiographical follow-up within 12
      months after treatment.
    

Detailed description: 
      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 immature
      molars 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 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 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).

      MTA Group (performed in 2 clinic visits, each visit will be approximately 30 minutes): MTA
      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 MTA plugs will
      be verified with a radiograph. After inserting MTA, a moist cotton pellet will be placed in
      the canal, and the access cavity will be restored with temporary filling (TG, Germany). Next
      day, under local anesthesia and rubber dam isolation, the temporary filling and the cotton
      pellet will be removed and the setting of MTA 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 follow-up after the end of
      treatment at 1, 3, 6 and 12 months. Periapical 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) and intraoral sensor (VATECH. Gyeonggi-do, Korea) . 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 in both groups
      blindly, 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.

      Patients of both groups will be recalled for clinical follow-up after the end of treatment at
      1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months to detect pain,
      swelling, tenderness to percussion, abscess, fistula, and abnormal tooth mobility Finally,
      the numerical data of the apical lesions sizes and ranked data of clinical variables will be
      statistically analyzed using SPSS, and any statistically significant values will be
      investigated.
    

Intervention name(s): Biodentine; MTA
Intervention type(s): Other; Other
Intervention description(s): After the endodontic procedure, Biodentine will be placed into the apical portion of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus. The coronal restoration will be completed with GIC, composite, and stainless-steel crown.; After the endodontic procedure, MTA will be placed into the apical portion of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus. The coronal restoration will be completed with GIC, composite, and stainless-steel crown.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Apexification; MTA; Biodentine; Immature molars