Effect of Different Root Canal Instruments on Removal of Endotoxins From Necrotic Root Canals
Condition: Endodontic Disease
MeSH terms: Dental Pulp Diseases
Study type: Interventional

Summary: 
      • Grouping: The patients will be randomly assigned into two equal groups Group : OneShape
      Group: ProtaperNext

        -  Endodontics procedure steps:

             1. Patient will be anesthetized by using infiltration local anesthesia or nerve block
                according to the tooth location in mandibular or maxillary arch respectively.

             2. All caries will be removed, then isolation using rubber dam, the crown and
                surrounding structures will be disinfected with 30% H2O2( hydrogen peroxide) for 30
                seconds, followed by 2.5% NaOCl for the same period of time and then inactivated
                with 5% sodium thiosulphate.

           2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will
           be used in conjunction with manual irrigation with sterile saline. Before entering the
           pulp chamber, the access cavity will be disinfected according to the protocol described
           above.

           2- Root canal length will be determined, by preoperative radiograph then (S1) will be
           taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the
           full length of the canal and left there for 1 minute. Then, the sample will be placed in
           an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex
           locator.

           3- Cleaning and shaping will be done using either One shape or Protaper next rotary
           instruments in crown down preparation technique with the use of in an endodontic motor
           according to the manufacturer instructions, the canals will be thoroughly irrigated
           using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument.

           4-After root canal preparation, NaOCl will be inactivated with 5 mL of sterile 5% sodium
           thiosulphate for 1 minute, which then will be removed with 5 mL of sterile/apyrogenic
           saline solution., which then will be removed with 5 mL of sterile/apyrogenic saline
           solution. second endotoxin sample (S2) will be taken from the root canals. (5 paper
           point size of the master cone).

           5- After completion of instrumentation and irrigation, obturation will be done using
           size 30/ 0.4 taper gutta-percha cones and auxiliaries as needed using the modified
           single cone technique.

      Determination of Endotoxin Concentration Human endotoxin (ET) ELISA Kit will be used to
      measure endotoxin concentrations in the root canals before and after chemomechanical
      procedures.
    

Detailed description: 
      Materials and Methods:

      A. Trial Design:

      The trial design of this study will be a prospective, parallel, Randomized clinical trial
      (RCT). The clinical trial involves research using human participants. In this trial, the
      participants will be randomly allocated to receive one of two interventions according to the
      protocol created by the investigator; one of these interventions will be the control. The
      investigator is to determine the safety and/or the efficacy of the interventions after being
      received by the participants by measuring the outcomes because the outcomes will be measured,
      RCTs are quantitative studies.

      • Grouping: The patients will be randomly assigned into two equal groups according to the
      type of rotary endodontic system used during root canal preparation: Group : OneShape Group :
      ProtaperNext

        -  Endodontics procedure steps:

             1. Patient will be anesthetized by using infiltration local anesthesia or nerve block
                according to the tooth location in mandibular or maxillary arch respectively.

             2. All caries will be removed, then isolation using rubber dam, the crown and
                surrounding structures will be disinfected with 30% H2O2 ( hydrogen peroxide) for
                30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated
                with 5% sodium thiosulphate.

           2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will
           be used in conjunction with manual irrigation with sterile saline. Before entering the
           pulp chamber, the access cavity will be disinfected according to the protocol described
           above.

           2- Root canal length will be determined, by preoperative radiograph then (S1) will be
           taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the
           full length of the canal and left there for 1 minute. Then, the sample will be placed in
           an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex
           locator.

           3- Cleaning and shaping will be done using either One shape or Protaper next rotary
           instruments in crown down preparation technique with the use of in an endodontic motor
           according to the manufacturer instructions, the canals will be thoroughly irrigated
           using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument.

           4-After root canal preparation, NaOCl will be inactivated with 5 mL of sterile 5% sodium
           thiosulphate for 1 minute, which then will be removed with 5 mL of sterile/apyrogenic
           saline solution., which then will be removed with 5 mL of sterile/apyrogenic saline
           solution. second endotoxin sample (S2) will be taken from the root canals. (5 paper
           point size of the master cone).

           5- After completion of instrumentation and irrigation, obturation will be done using
           size 30/ 0.4 taper gutta-percha cones and auxiliaries as needed using the modified
           single cone technique.

           6- All procedures will be done in a single-visit, checked radiographically and recorded
           in the procedure chart.

      Determination of Endotoxin Concentration Human endotoxin (ET) ELISA Kit will be used to
      measure endotoxin concentrations in the root canals before and after chemomechanical
      procedures.

      As a parameter for calculation of the amount of endotoxins in the root canal samples, a
      standard curve will be plotted by using the endotoxin of known concentration supplied by the
      kit according to the manufacturer's instructions.

      The test procedure will be performed according to the manufacturer's instructions. And the
      absorbance of endotoxins will be measured by using spectrophotometer at wavelength 450 nm.

      D. Outcomes:

      Evaluation of the antibacterial effect of using One Shape and Protaper Next rotary endodontic
      NiTi instruments for root canal preparation using Human endotoxin (ET) ELISA Kit

      E. Randomization:

      The randomization will be done in three steps:

        1. Sequence generation:

           The random sequence generation will be done for the patients' numbers (from 1 to 38)
           using Microsoft Excel software.

           Allocation concealment mechanism:

           The allocation concealment will be phone-based.

        2. Implementation:

      The random sequence will be done by a colleague and the random sequence table will be kept
      with him. After eligibility assessment, the operator would call the colleague for eligibility
      checking and to know the group assignment for the patients.

      F. Blinding:

      Participants, outcome assessor and data analyst will be blinded in this trial. The operator
      will be not blinded.
    

Intervention name(s): one shape; protaper next
Intervention type(s): Other; Other
Intervention description(s): canal fluid sample before and after root canal instrumentation; canal fluid sample before and after root canal instrumentation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The trial design of this study will be a prospective, parallel, Randomized clinical trial (RCT).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: rotary instruments; endotoxins