Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation
Condition: Manual; Rotation; Obturation; Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Manual files used for the pulpectomy of primary teeth have some disadvantages such as time
      wastage and the occurrence of iatrogenic errors compared to rotary systems.

      Little studies have been done to clinically evaluate the Kedo-S Square & Fanta AF™ Baby
      rotary systems in relation to the quality of obturation, instrumentation time and
      postoperative pain in root canal preparation of primary molars using CBCT.
    

Detailed description: 
      Biomechanical preparation is one of the most important steps of primary teeth pulpectomy,
      which are primarily targeted during canal debridement . Conventionally, hand files were used
      for cleaning and shaping in primary teeth with some disadvantages such as time wastage and
      the occurrence of iatrogenic errors such as zipping, lateral perforations, apical
      obstruction, and canal transportation.

      The use of rotary instruments for primary tooth instrumentation is faster, affordable, and
      yields consistent, reliable results. Numerous rotary endodontic systems designed primarily
      for application in permanent teeth, have been suggested for primary teeth root canal
      preparation. Since the primary teeth have a ribbon-shaped anatomy and shorter, thinner curved
      roots than permanent teeth, the use of these files in pulpectomy of primary teeth could
      produce lateral perforations. As a result, there was a great need for the development of a
      unique pediatric rotary file system.

      The Kedo-S Square rotary system is a single file system specifically designed for paediatric
      use. It consists of two files, one for anterior primary teeth (A1) and one for posterior
      primary teeth (P1) also, Fanta AF™-Baby rotary system, another specifically generated
      paediatric rotary file, was produced using Ni-Ti controlled memory (CM)-Wire technology.

      A good root canal treatment in primary teeth is dependent on the quality of biomechanical
      preparation, the type of obturating material used with as few voids as possible, and the
      achievement of a good hermetic seal. Also, treatment time is an important aspect as reduced
      chairside time increases children's cooperation for dental treatment, reduces anxiety, and
      making the treatment protocol optimal. Another factor affecting the success of primary teeth
      pulpectomy is the postoperative pain which may be due to extrusion of foreign particles into
      peri-radicular tissues accordingly, causing inflammation and releasing inflammatory
      mediators.
    

Intervention name(s): pulpectomy procedure; Post-operative Cone Beam Computed Tomography; Post-operative pain assessment
Intervention type(s): Procedure; Radiation; Other
Intervention description(s): single visit pulpectomy was performed under strict aseptic conditions by a single operator. Peri-operative evaluation was done using intraoral digital senso. The teeth were anesthetized with 2% mepivacaine with 1:20,000 levonordefrin & isolated using rubber dam. caries was removed using no. 330 round carbide burs in high-speed contra angle headpiece. Access opening was gained & the roof of the pulp chamber was removed. Working length was determined by apex locator, then confirmed by periapical radiograph. Working length will be determined 1 mm shorter than apex. mechanical preparation was done using the tested files according to each group. Then, canals were irrigated with 1% sodium hypochlorite between each file followed by irrigation with normal saline. The root canals were dried using paper points & root canals were filled with Metapex. Intermediate restorative material was placed, and the tooth was restored with a preformed stainless-steel crown in the same appointment.; post-operative CBCT image was taken after completing the procedure with fixed exposure parameters (120 Kv, 5mA and 0.125mm voxel size) using smallest field of view (8D, 8Hcm) to improve spatial resolution. The CBCT images were obtained by using 3D module of On Demand Dental software (version 1.0 (build 1.0.10.7462),× 64 Edition, copyright 2004-2017 Cybermed, Korea and license key 670094709).
The Immediate post-operative CBCT was taken to evaluate the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique .; The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. The four-point pain intensity scale was used to record postoperative pain (figure 5). This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents. The children returned to the department two days after the pulpectomy procedure with their completed questionnaire form.
Other intervention name(s): Obturation Quality Assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, controlled prospective clinical study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cone-beam computed tomography; kedo-S square; Fanta AF™ Baby