<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03301259</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2017-06-17</org_study_id>
    <nct_id>NCT03301259</nct_id>
  </id_info>
  <brief_title>Postoperative Pain Following Treatment of Asymptomatic Necrotic Mandibular Molars in Single Visit Using Wave-one Reciprocating Instruments Versus One-Shape Rotary Instruments</brief_title>
  <official_title>Evaluation of the Post Treatment Pain After Instrumentation of Root Canals With a Single File Reciprocating (Wave-One Ni Ti File, DENTSPLY Maillefer) or Rotary(One Shape, Micro Mega, France) File System in Patient With Asymptomatic Necrotic Molars</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the post treatment pain after instrumentation of root&#xD;
      canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or&#xD;
      rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic&#xD;
      molars This trial will help to clinically evaluate the use of reciprocating motion in&#xD;
      endodontic treatment in necrotic teeth without periapical lesion therefore reduce the&#xD;
      post-obtuation pain&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to evaluate the post treatment pain after instrumentation of root&#xD;
      canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or&#xD;
      rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic&#xD;
      molars This trial will help to clinically evaluate the use of reciprocating motion in&#xD;
      endodontic treatment in necrotic teeth without periapical lesion therefore reduce the&#xD;
      post-obtuation pain&#xD;
&#xD;
      Sample&#xD;
&#xD;
      if the success rate (no pain) for wave one subjects is 0.3, we will need to study 17 patients&#xD;
      in each group to be able to reject the null hypothesis that the failure rates for&#xD;
      experimental and control subjects are equal with probability (power) 0.8. the type 1 error&#xD;
      probability associated with this test of this null hypothesis. This no is to be increased to&#xD;
      total no 42 to compensate for losses during follow up , the sample size was calcukated by the&#xD;
      PS program&#xD;
&#xD;
      Patients are recruited for the clinical trial from the clinic of endodontics at the Faculty&#xD;
      of Oral and Dental Medicine, Cairo University to meet the target sample size.&#xD;
&#xD;
      A random sequence will be generated by computer software, (http://www.random.org/) in the&#xD;
      Center of Evidence Based Dentistry, Cairo University. This table will be kept with a&#xD;
      co-investigator&#xD;
&#xD;
      The operator finds an eligible participant, then to assign the Participant to either group&#xD;
      according to the generated random sequence.&#xD;
&#xD;
      The operator finds an eligible participant, then to assign the Participant to either group&#xD;
      according to the generated random sequence.&#xD;
&#xD;
      We will generate the random sequence, assign the participants to the intervention or control&#xD;
      groups.&#xD;
&#xD;
      The operators will enroll the participants after they find the eligible ones.&#xD;
&#xD;
      Outpatients of the clinic of endodontics at the Faculty of Oral and Dental Medicine, Cairo&#xD;
      University, Egypt.&#xD;
&#xD;
        -  The dental Unit is Adec 200 U.S.A.&#xD;
&#xD;
        -  The x-ray Machine is ViVi, S.r.I, Italy&#xD;
&#xD;
        -  The x-ray films are Kodac, speed D, size 2 or Digital (RVG)&#xD;
&#xD;
        -  The operator is a master degree student in the department of Endodontics&#xD;
&#xD;
      Radiographic examination using periapical radiographic film which shows normal periapical&#xD;
      tissues with normal lamina dura and width of the periodontal membrane space and absence of&#xD;
      periapical lesion&#xD;
&#xD;
      Assessment of pre-operative pain:&#xD;
&#xD;
      The patients will be asked to record the level of pain on a VAS. The patient will be trained&#xD;
      that 0 is no pain, 10 is the worst pain, and he will be asked to estimate the pain from 0 to&#xD;
      10 which then will be scored as follows:&#xD;
&#xD;
      0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain&#xD;
&#xD;
      The standard procedure for both groups in single visit&#xD;
&#xD;
      Standard access cavity will be prepared. Isolation will be performed using rubber dam.&#xD;
&#xD;
      K file 10 or 15 will be used to check the patency of the canal. ENDOFLARE will be used for&#xD;
      enlarging the coronal third of the canal in cases which will be treated with One Shape&#xD;
      Lubricant gel will be used as a lubricant and 2.5% NaOCl as irrigant. Determination of the&#xD;
      working length of canal will be done by electronic apex locator and confirmed by periapical&#xD;
      radiograph.&#xD;
&#xD;
      Intervention group Root canal preparation will be done with theWaveOne System with strict&#xD;
      adherence to the manufacturer's instructions. After coronal preflaring with File ISO 21 taper&#xD;
      8% instrument with 2.5% sodium hypochlorite as the irrigant, working length was determined&#xD;
      and a glide path will created.&#xD;
&#xD;
      The Red file R 25 taper 8% will be used for preparing the mesial canal; and the Black ISO 40&#xD;
      taper 8% file will be used for preparing the distal canals where there is only a single&#xD;
      canal.&#xD;
&#xD;
      Control Group: canals will be prepared by OneShape (MICRO-MEGA) rotary nickel-titanium file&#xD;
      at 400 rpm. The preparation will be stopped by One Shape N°25 - .06 in mesial canals and&#xD;
      distal roots with 2 canals; while in case of a single distal canal, the preparation will be&#xD;
      stopped by One Shape apical N°30 - .06 rotary files.&#xD;
&#xD;
      Obturation:&#xD;
&#xD;
      After instrumentation and final irrigation, canals will be dried with paper points.&#xD;
&#xD;
      Teeth will be obturated during the initial appointment using epoxy resin sealer.&#xD;
&#xD;
      All the patients will be asked to take a placebo if they experience pain after the&#xD;
      procedures. If the patient experience moderate pain he is allowed to take 50mg diclofenac&#xD;
      potassium (cataflam 50mg). Any of the patients with intolerable pain will be requested to&#xD;
      visit the clinician for emergency treatment. The patients will be asked to record the no. of&#xD;
      pills taken and the time at which it was taken.&#xD;
&#xD;
      Assessment of post-operative pain:&#xD;
&#xD;
      Post-operative pain is defined as any degree of pain that occurs after initiation of root&#xD;
      canal treatment, while flare up is defined as the development or continuation of pain and/or&#xD;
      swelling after endodontic treatment.&#xD;
&#xD;
      The will be asked to record the level of pain at 6 hours, 24 hours, 48 hours and 7days after&#xD;
      obturation.&#xD;
&#xD;
      The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his&#xD;
      daily routine, and he will be asked to estimate the pain as follows:&#xD;
&#xD;
      0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 15, 2018</start_date>
  <completion_date type="Anticipated">August 15, 2018</completion_date>
  <primary_completion_date type="Anticipated">May 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post operative pain</measure>
    <time_frame>changes after 6 hours , 24 hours , 48 hours , 7 days The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain from 0 to 10</time_frame>
    <description>Post operative pain after mechanical preparation with wave one and one shape using VAS scale from 0 to 10&#xD;
Post-operative pain is defined as any degree of pain that occurs after initiation of root canal treatment, while flare up is defined as the development or continuation of pain and/or swelling after endodontic treatment.&#xD;
The will be asked to record the level of pain at 6 hours, 24 hours, 48 hours and 7days after obturation.&#xD;
The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain as follows:&#xD;
0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Necrotic Pulp</condition>
  <arm_group>
    <arm_group_label>wave -one reciprocating system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The reciprocating single file systems WaveOne (Maillefer, Ballaigues, Switzerland) provide more flexibility of the M-wire Ni-Ti alloy, greater resistance to cyclic fatigue and better handling of narrow and curved canals than the traditional Ni-Ti instruments Root canal preparation will be done with theWaveOne System with strict adherence to the manufacturer's instructions. After coronal preflaring with File ISO 21 taper 8% instrument with 2.5% sodium hypochlorite as the irrigant, working length was determined and a glide path will created.&#xD;
The Red file R 25 taper 8% will be used for preparing the mesial canal; and the Black ISO 40 taper 8% file will be used for preparing the distal canals where there is only a single canal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OneShape</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OneShape (MICRO-MEGA) rotary nickel-titanium use roation movement and available in two sizes N°30 - .06 rotary files. , N°25 - .06</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>One-shape rotationary system</intervention_name>
    <description>OneShape (MICRO-MEGA) rotary nickel-titanium use roation movement and available in two sizes N°30 - .06 rotary files. , N°25 - .06</description>
    <arm_group_label>OneShape</arm_group_label>
    <arm_group_label>wave -one reciprocating system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Medically free patients&#xD;
&#xD;
          2. Patient's age between 25-50 years.&#xD;
&#xD;
          3. Mandibular molars diagnosed clinically as necrotic with normal apical tissues.&#xD;
&#xD;
          4. Positive patient's acceptance for participation in the study.&#xD;
&#xD;
          5. Both genders are included.&#xD;
&#xD;
          6. Patients able to sign informed consent.&#xD;
&#xD;
          7. Normal periodontal tissues.&#xD;
&#xD;
          8. Normal periapical tissues on the radiograph&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with complicating systemic disease.&#xD;
&#xD;
          2. Having severe pain and/or acute apical abscesses.&#xD;
&#xD;
          3. Under the age of 25 years.&#xD;
&#xD;
          4. Patients using antibiotics or analgesic 12 hours before the procedures.&#xD;
&#xD;
          5. Having multiple teeth that required treatment.&#xD;
&#xD;
          6. With non-restorable and/or periodontally compromised teeth.&#xD;
&#xD;
          7. Retreatment cases&#xD;
&#xD;
          8. Presence of sinus tract&#xD;
&#xD;
          9. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>ahhmed Ragab</last_name>
    <phone>01005674370</phone>
    <email>ahmed-ragab@dentistry.cu.edu.eg</email>
  </overall_contact>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>December 3, 2017</last_update_submitted>
  <last_update_submitted_qc>December 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Ragab Mohamed</investigator_full_name>
    <investigator_title>master candidate at endodontic department faculty of oral and dental medicine CU</investigator_title>
  </responsible_party>
  <keyword>Necrotic pulp</keyword>
  <keyword>wave-one</keyword>
  <keyword>one-shape</keyword>
  <keyword>periapical lesion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Pulp Necrosis</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03301259
org study id: CEBC-CU-2017-06-17
nct id: NCT03301259
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the post treatment pain after instrumentation of root
      canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or
      rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic
      molars This trial will help to clinically evaluate the use of reciprocating motion in
      endodontic treatment in necrotic teeth without periapical lesion therefore reduce the
      post-obtuation pain
The aim of this study is to evaluate the post treatment pain after instrumentation of root
      canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or
      rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic
      molars This trial will help to clinically evaluate the use of reciprocating motion in
      endodontic treatment in necrotic teeth without periapical lesion therefore reduce the
      post-obtuation pain

      Sample

      if the success rate (no pain) for wave one subjects is 0.3, we will need to study 17 patients
      in each group to be able to reject the null hypothesis that the failure rates for
      experimental and control subjects are equal with probability (power) 0.8. the type 1 error
      probability associated with this test of this null hypothesis. This no is to be increased to
      total no 42 to compensate for losses during follow up , the sample size was calcukated by the
      PS program

      Patients are recruited for the clinical trial from the clinic of endodontics at the Faculty
      of Oral and Dental Medicine, Cairo University to meet the target sample size.

      A random sequence will be generated by computer software, (http://www.random.org/) in the
      Center of Evidence Based Dentistry, Cairo University. This table will be kept with a
      co-investigator

      The operator finds an eligible participant, then to assign the Participant to either group
      according to the generated random sequence.

      The operator finds an eligible participant, then to assign the Participant to either group
      according to the generated random sequence.

      We will generate the random sequence, assign the participants to the intervention or control
      groups.

      The operators will enroll the participants after they find the eligible ones.

      Outpatients of the clinic of endodontics at the Faculty of Oral and Dental Medicine, Cairo
      University, Egypt.

        -  The dental Unit is Adec 200 U.S.A.

        -  The x-ray Machine is ViVi, S.r.I, Italy

        -  The x-ray films are Kodac, speed D, size 2 or Digital (RVG)

        -  The operator is a master degree student in the department of Endodontics

      Radiographic examination using periapical radiographic film which shows normal periapical
      tissues with normal lamina dura and width of the periodontal membrane space and absence of
      periapical lesion

      Assessment of pre-operative pain:

      The patients will be asked to record the level of pain on a VAS. The patient will be trained
      that 0 is no pain, 10 is the worst pain, and he will be asked to estimate the pain from 0 to
      10 which then will be scored as follows:

      0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain

      The standard procedure for both groups in single visit

      Standard access cavity will be prepared. Isolation will be performed using rubber dam.

      K file 10 or 15 will be used to check the patency of the canal. ENDOFLARE will be used for
      enlarging the coronal third of the canal in cases which will be treated with One Shape
      Lubricant gel will be used as a lubricant and 2.5% NaOCl as irrigant. Determination of the
      working length of canal will be done by electronic apex locator and confirmed by periapical
      radiograph.

      Intervention group Root canal preparation will be done with theWaveOne System with strict
      adherence to the manufacturer's instructions. After coronal preflaring with File ISO 21 taper
      8% instrument with 2.5% sodium hypochlorite as the irrigant, working length was determined
      and a glide path will created.

      The Red file R 25 taper 8% will be used for preparing the mesial canal; and the Black ISO 40
      taper 8% file will be used for preparing the distal canals where there is only a single
      canal.

      Control Group: canals will be prepared by OneShape (MICRO-MEGA) rotary nickel-titanium file
      at 400 rpm. The preparation will be stopped by One Shape N°25 - .06 in mesial canals and
      distal roots with 2 canals; while in case of a single distal canal, the preparation will be
      stopped by One Shape apical N°30 - .06 rotary files.

      Obturation:

      After instrumentation and final irrigation, canals will be dried with paper points.

      Teeth will be obturated during the initial appointment using epoxy resin sealer.

      All the patients will be asked to take a placebo if they experience pain after the
      procedures. If the patient experience moderate pain he is allowed to take 50mg diclofenac
      potassium (cataflam 50mg). Any of the patients with intolerable pain will be requested to
      visit the clinician for emergency treatment. The patients will be asked to record the no. of
      pills taken and the time at which it was taken.

      Assessment of post-operative pain:

      Post-operative pain is defined as any degree of pain that occurs after initiation of root
      canal treatment, while flare up is defined as the development or continuation of pain and/or
      swelling after endodontic treatment.

      The will be asked to record the level of pain at 6 hours, 24 hours, 48 hours and 7days after
      obturation.

      The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his
      daily routine, and he will be asked to estimate the pain as follows:

      0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post operative pain
time frame: changes after 6 hours , 24 hours , 48 hours , 7 days The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain from 0 to 10
description: Post operative pain after mechanical preparation with wave one and one shape using VAS scale from 0 to 10
Post-operative pain is defined as any degree of pain that occurs after initiation of root canal treatment, while flare up is defined as the development or continuation of pain and/or swelling after endodontic treatment.
The will be asked to record the level of pain at 6 hours, 24 hours, 48 hours and 7days after obturation.
The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain as follows:
0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain
arm group label: wave -one reciprocating system
arm group type: Experimental
description: The reciprocating single file systems WaveOne (Maillefer, Ballaigues, Switzerland) provide more flexibility of the M-wire Ni-Ti alloy, greater resistance to cyclic fatigue and better handling of narrow and curved canals than the traditional Ni-Ti instruments Root canal preparation will be done with theWaveOne System with strict adherence to the manufacturer's instructions. After coronal preflaring with File ISO 21 taper 8% instrument with 2.5% sodium hypochlorite as the irrigant, working length was determined and a glide path will created.
The Red file R 25 taper 8% will be used for preparing the mesial canal; and the Black ISO 40 taper 8% file will be used for preparing the distal canals where there is only a single canal.
arm group label: OneShape
arm group type: Experimental
description: OneShape (MICRO-MEGA) rotary nickel-titanium use roation movement and available in two sizes N°30 - .06 rotary files. , N°25 - .06
intervention type: Other
intervention name: One-shape rotationary system
description: OneShape (MICRO-MEGA) rotary nickel-titanium use roation movement and available in two sizes N°30 - .06 rotary files. , N°25 - .06
arm group label: OneShape
arm group label: wave -one reciprocating system
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: ahhmed Ragab
phone: 01005674370
email: ahmed-ragab@dentistry.cu.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Ragab Mohamed
investigator title: master candidate at endodontic department faculty of oral and dental medicine CU
mesh term: Dental Pulp Necrosis
mesh term: Necrosis
sharing ipd: Undecided