xml: <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/NCT06027931</url>
    </required_header>
    <id_info>
      <org_study_id>Ahmed Alani 1983</org_study_id>
      <nct_id>NCT06027931</nct_id>
    </id_info>
    <brief_title>Traditional Versus Conservative Access Cavities Cleaning Ability</brief_title>
    <official_title>12-months Clinical and Radiographical Outcomes of Root Canal Treatment After Traditional Versus Conservative Access Cavities: A Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Baghdad</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Baghdad</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Aims of the study:&#xD;
  &#xD;
          1. Assess the clinical and radiographical outcomes (success/failure) of root canal&#xD;
             treatments performed after traditional vs conservative access cavities in permanent&#xD;
             posterior teeth after one-year follow-up.&#xD;
  &#xD;
          2. Assess the level of disinfection in root canals accessed by traditional vs conservative&#xD;
             access cavities in permanent posterior teeth before obturation.&#xD;
  &#xD;
        Null hypothesis:&#xD;
  &#xD;
        1. There is no difference in the clinical and radiographical outcomes of root canal&#xD;
        treatments performed after traditional and conservative access cavities preparation in&#xD;
        posterior teeth after one-year of follow-up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives:&#xD;
  &#xD;
        1- Primary outcomes:&#xD;
  &#xD;
          1. A single-blind, 2- arms, parallel 2-groups, randomized controlled clinical trial will be&#xD;
             conducted in two groups of patients to assess the clinical and radiographical outcomes&#xD;
             (success/failure) of root canal treatments after one year follow-up of posterior teeth&#xD;
             accessed by traditional or conservative access cavities using CBCT as a strict&#xD;
             radiographic adjunct in the assessment in addition to the conventional clinical tests&#xD;
             and the 2- dimensional radiographs.&#xD;
  &#xD;
             The successful outcome will include:&#xD;
  &#xD;
             I. The absence of clinical signs and symptoms (pain, tenderness to percussion, sinus&#xD;
             tract, swelling).&#xD;
  &#xD;
             II. No pathosis is evident on the recall CBCT such as root resorption, new furcal, or&#xD;
             periapical rarefaction.&#xD;
  &#xD;
             III. Complete radiographic healing or reduction in the radiolucency if periapical&#xD;
             rarefaction was present preoperatively.&#xD;
  &#xD;
             The clinical assessment will be performed by a blind clinical observer and the&#xD;
             radiographical outcome will include an assessment of pretreatment and posttreatment CBCT&#xD;
             scans by blinded two observers (a consensus panel).&#xD;
  &#xD;
          2. A microbiological study will be performed to assess the level of disinfection in the&#xD;
             root canals accessed by traditional versus the conservative access cavities by measuring&#xD;
             the total bacterial count before and after the instrumentation of the root canals.&#xD;
  &#xD;
             2- Secondary outcomes of the trial:&#xD;
  &#xD;
             1- Assessment of crown fracture during the one-year follow-up period (if any). 2-&#xD;
             Assessment of fracture file events during treatment phase. 3- Assess the accuracy of&#xD;
             CBCT vs periapical radiographs in detection of periapical lesion in baseline and&#xD;
             follow-up radiographical assessment.&#xD;
  &#xD;
             Materials &amp; Method:&#xD;
  &#xD;
             Study design:&#xD;
  &#xD;
             This single blind, 2-arms, parallel groups, randomized clinical trial study is planned&#xD;
             to be conducted in a private dental center in Baghdad, Iraq. Ethical approval will be&#xD;
             granted from the Ethics committee in the College of Dentistry/University of Baghdad.&#xD;
  &#xD;
             CBCT scan and periapical radiograph will be taken for each case preoperatively, and&#xD;
             another CBCT will be acquired after 1-year follow-up. These scans and radiographs will&#xD;
             be assessed by a consensus panel of two academic endodontists in the department of&#xD;
             Esthetic and restorative dentistry.&#xD;
  &#xD;
             A customized case sheet was prepared to be filled before starting with the treatment,&#xD;
             after getting patient approval on participation in the study and signature the consent&#xD;
             form. Case sheets and consent forms in Arabic and English languages are in the last&#xD;
             pages in this protocol.&#xD;
  &#xD;
             3.2. Sample size calculation: This study was designed to have 80% power with an alpha&#xD;
             margin of error of 5%, the sample size was calculated using G-power to detect an&#xD;
             expected difference of 25% in failed outcomes between the two groups after one year of&#xD;
             follow-up, a total sample size of 84 root canal treatments in two groups (each group =&#xD;
             42) was calculated anticipating 10% loss of follow-up after one year.&#xD;
  &#xD;
             Cases selection:&#xD;
  &#xD;
             Inclusion criteria: mature maxillary and mandibular (first molars, first, and second&#xD;
             premolars) that have clinical signs and symptoms of irreversible pulpitis or necrotic&#xD;
             pulps that may or may not show apical periodontitis or chronic apical lesions on the&#xD;
             preoperative CBCT scan or periapical radiograph.&#xD;
  &#xD;
             Exclusion criteria: pregnancy, immunosuppression, patients received radiotherapy,&#xD;
             unrestorable teeth, teeth with periodontal probing depths greater than 3 mm,&#xD;
             uncontrolled periodontal disease, presence of airways disease or allergy, vertical root&#xD;
             fractures, signs of root resorption, or patient age over 70 years old.&#xD;
  &#xD;
             3.4. Randomization and patients Grouping: Block randomization will be performed using&#xD;
             computer software, the tooth will be the unit of randomization. The following factors&#xD;
             will be equalized during the allocation of teeth to the study arms: Gender&#xD;
             (male/female), Age median, tooth type (molar/premolar), periapical lesion&#xD;
             (presence/absence).&#xD;
  &#xD;
             Materials and Equipment:&#xD;
  &#xD;
             List of materials:&#xD;
  &#xD;
             1. Barbed broaches (Dentsply Maillefer, USA). 2. Disposable nitril gloves (Provi,&#xD;
             Malaysia). 3. Disposable syringe 5ml (Malaysia) 4. EDTA solution 17% (Produits Dentaires&#xD;
             SA, Switzerland) 5. Glyde (Dentsply, Sirona). 6. Bioceramic root canal sealer (BioRoot&#xD;
             ™Flow, Septodont). 7. K-files #10 (Dentsply Maillefer, Switzerland). 8. K-files #15&#xD;
             (Dentsply Maillefer, Switzerland). 9. NAOCL 5.25 % (Cerkamed, Poland). 10. Protaper Gold&#xD;
             rotary files (Dentsply, Sirona). 11. Transfer sponges (Dentsply Maillefer, Switzerland).&#xD;
             12. Irrigation needles 0.3 x 25(Cerkamed, Poland). 13. Normal saline. 14. Paper point&#xD;
             (Dentsply, Maillefer, Switzerland). 15. Dam sheets (Sanctuary). 16. Gutta percha cones&#xD;
             (Dentsply Maillefer, Switzerland). 17. Burs (Endo Z).&#xD;
  &#xD;
             Instruments:&#xD;
  &#xD;
               1. Diagnostic instruments (mirror, probe, and Tweezers) (Medesey, Italy).&#xD;
  &#xD;
               2. Rubber Dam kit.&#xD;
  &#xD;
               3. Endodontic plugger (Medesey, Italy)&#xD;
  &#xD;
               4. Endodontic ruler (Dentsply, Sirona).&#xD;
  &#xD;
               5. Ultrasonic Endotips.&#xD;
  &#xD;
               6. Ethyl chloride and electric pulp tester.&#xD;
  &#xD;
             Equipment:&#xD;
  &#xD;
               1. X-Smart IQ Cordless Endodontic Motor (Dentsply, Sirona).&#xD;
  &#xD;
               2. High-speed handpiece (Bien Air, Optima, Switzerland).&#xD;
  &#xD;
               3. Low-speed handpiece (NSK, Japan)&#xD;
  &#xD;
               4. Apex locator (NSK, Apex II, Japan).&#xD;
  &#xD;
               5. An ultrasonic scaler (Ultramint &amp; Ultramint Pro, Eighteeth).&#xD;
  &#xD;
             Endodontic procedure:&#xD;
  &#xD;
             1. Tooth Preparation: An individual patient's data, including case history, clinical and&#xD;
             radiological assessment, treatment plan and periodic follow-up of the patients will be&#xD;
             recorded. Preoperative CBCT and periapical radiograph will be taken for each patient&#xD;
             before starting the treatment. The time required for complete endodontic procedure will&#xD;
             be recorded from the start of treatment for each case. Following anesthesia caries&#xD;
             removal will be performed and restorability will be confirmed. In case of missing walls&#xD;
             (Class II) cavity, pre-endodontic build-up will be performed. With rubber dam isolation,&#xD;
             endodontic treatment will be started, after a straight-line access cavity is prepared by&#xD;
             maintaining standard protocol, with confirmation of patency with size 8 and 10 k files.&#xD;
             Working length will be confirmed with an electronic apex locator and radiograph, canals&#xD;
             will be enlarged using Protaper Gold file system to Size F2 at minimum and for MB2 size&#xD;
             F2 will be considered the master apical file with 2% sodium hypochlorite irrigation&#xD;
             throughout the procedure, finally, the irrigant will be left in the canal and activated&#xD;
             by smooth ultrasonic file (size 15, 0.02 taper) that placed into the canal to 1 mm short&#xD;
             of the WL without touching the walls, enabling it to vibrate freely for 1 min (Hegde and&#xD;
             Arora, 2015). Then final irrigation was done with 17% liquid ethylenediamine tetra&#xD;
             acetic acid (17%EDTA) to remove the smear layer then irrigation with 2.5% NaOCl solution&#xD;
             was placed and agitated for 60 seconds followed by a final irrigation with 1 mL of&#xD;
             saline solution (Tavares, 2020). The canals will be dried with paper point, and master&#xD;
             cone (gutta-percha) to be selected depending on master apical file for canals.&#xD;
             Obturation will be performed with bioceramic sealer (BC) using single cone technique.&#xD;
  &#xD;
             2 Bacterial Count (Sample Collection): During sample collection, a sterile absorbent&#xD;
             paper points size F2 will be introduced individually in the pulp chamber space before&#xD;
             access cavity preparation and remained in this position for 60 seconds. After this, the&#xD;
             paper point will be stored in a sterile microtube (2 mL) containing 1 mL pyrogenic water&#xD;
             for subsequent microbiological analysis of Colony Forming Unit (CFU). This will be&#xD;
             considered the base line measurement. After access cavity preparation and&#xD;
             instrumentation, the second paper point will be inserted in the root canal space and&#xD;
             remain in this position for 60 seconds and then will be stored in a sterile microtube (2&#xD;
             mL) containing 1 mL pyrogenic water for subsequent microbiological analysis of Colony&#xD;
             Forming Unit (CFU). This will be regarded as a second measurement for comparison&#xD;
             purposes.&#xD;
  &#xD;
             3. Obturation BC sealer is chosen to be used in this study as it has exceptional&#xD;
             dimensional stability and does not shrink upon setting; it is non-resorbable inside root&#xD;
             canal. Furthermore, the formation of calcium hydroxide as a by-product of the setting&#xD;
             reaction (initiated by moisture present in dentinal tubules) produces a very high&#xD;
             alkaline pH (12.8) rendering the material antibacterial. It exhibits excellent&#xD;
             biocompatibility; significant stimulation of periodontal regeneration and it is&#xD;
             osteoconductive. All teeth will be referred back for final restoration within 1 month.&#xD;
  &#xD;
             Bioceramic root canal sealer is supplied in premix tube with disposable tips of narrow&#xD;
             caliber. The syringe cap is to be removed from the syringe and intra canal tip to be&#xD;
             attached with a clockwise twist to the hub of the syringe. Sealer will be injected into&#xD;
             the coronal half of the canal and premeasured master gutta-percha (GP) point will be&#xD;
             inserted it into the canal very slowly. GP carried sufficient sealer to the apex. Excess&#xD;
             GP points will be removed from the pulp chamber by a heated plugger.&#xD;
  &#xD;
             4. Review of patients: Patients will be reviewed with a clinical and radiographic&#xD;
             examination, one year after treatment. During this examination, CBCT will be taken using&#xD;
             the same exposure settings as the initial scan.&#xD;
  &#xD;
             5. Radiographic assessment: Two examiners who had not been involved in clinical&#xD;
             examination or treatment of patients will assess all the CBCT scans. Preoperative and&#xD;
             follow-up CBCT images will be assessed for the presence of apical periodontitis, and&#xD;
             dimension of periapical lesion.&#xD;
  &#xD;
             The assessment will be carried out on the coronal and sagittal slices at the equatorial&#xD;
             level of the tooth of interest.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">September 12, 2022</start_date>
    <completion_date type="Anticipated">May 12, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 12, 2024</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>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The absence of clinical signs and symptoms in participants.</measure>
      <time_frame>1 year</time_frame>
      <description>(pain, tenderness to percussion, sinus tract, swelling).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">82</enrollment>
    <condition>Root Canal Infection</condition>
    <condition>Root Canal Treatment</condition>
    <arm_group>
      <arm_group_label>Conservative Access Opening</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Root canal treatment using Conservative Access Opening type.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Traditional Access Opening</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Root canal treatment using Traditional Access Opening type.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Conservative Access Opening, Traditional Access Opening</intervention_name>
      <description>Conservative Access Opening will be used and evaluated for cleaning ability versus Traditional Access Opening.</description>
      <arm_group_label>Conservative Access Opening</arm_group_label>
      <arm_group_label>Traditional Access Opening</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of root canal disease.&#xD;
  &#xD;
            -  Must be able to undergo endodontic treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy patients.&#xD;
  &#xD;
            -  patients received radiotherapy.&#xD;
  &#xD;
            -  patient age over 70 years old.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmed H Ali, Ph.D</last_name>
      <role>Study Director</role>
      <affiliation>University of Baghdad</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Private Dental Center</name>
        <address>
          <city>Baghdad</city>
          <zip>00964</zip>
          <country>Iraq</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Baghdad</investigator_affiliation>
      <investigator_full_name>Ahmed Alani</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Root Canal,CFU</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>CBCTs</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027931
  org study id: Ahmed Alani 1983
  nct id: NCT06027931
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Aims of the study:
  
          1. Assess the clinical and radiographical outcomes (success/failure) of root canal
             treatments performed after traditional vs conservative access cavities in permanent
             posterior teeth after one-year follow-up.
  
          2. Assess the level of disinfection in root canals accessed by traditional vs conservative
             access cavities in permanent posterior teeth before obturation.
  
        Null hypothesis:
  
        1. There is no difference in the clinical and radiographical outcomes of root canal
        treatments performed after traditional and conservative access cavities preparation in
        posterior teeth after one-year of follow-up.
  Objectives:
  
        1- Primary outcomes:
  
          1. A single-blind, 2- arms, parallel 2-groups, randomized controlled clinical trial will be
             conducted in two groups of patients to assess the clinical and radiographical outcomes
             (success/failure) of root canal treatments after one year follow-up of posterior teeth
             accessed by traditional or conservative access cavities using CBCT as a strict
             radiographic adjunct in the assessment in addition to the conventional clinical tests
             and the 2- dimensional radiographs.
  
             The successful outcome will include:
  
             I. The absence of clinical signs and symptoms (pain, tenderness to percussion, sinus
             tract, swelling).
  
             II. No pathosis is evident on the recall CBCT such as root resorption, new furcal, or
             periapical rarefaction.
  
             III. Complete radiographic healing or reduction in the radiolucency if periapical
             rarefaction was present preoperatively.
  
             The clinical assessment will be performed by a blind clinical observer and the
             radiographical outcome will include an assessment of pretreatment and posttreatment CBCT
             scans by blinded two observers (a consensus panel).
  
          2. A microbiological study will be performed to assess the level of disinfection in the
             root canals accessed by traditional versus the conservative access cavities by measuring
             the total bacterial count before and after the instrumentation of the root canals.
  
             2- Secondary outcomes of the trial:
  
             1- Assessment of crown fracture during the one-year follow-up period (if any). 2-
             Assessment of fracture file events during treatment phase. 3- Assess the accuracy of
             CBCT vs periapical radiographs in detection of periapical lesion in baseline and
             follow-up radiographical assessment.
  
             Materials & Method:
  
             Study design:
  
             This single blind, 2-arms, parallel groups, randomized clinical trial study is planned
             to be conducted in a private dental center in Baghdad, Iraq. Ethical approval will be
             granted from the Ethics committee in the College of Dentistry/University of Baghdad.
  
             CBCT scan and periapical radiograph will be taken for each case preoperatively, and
             another CBCT will be acquired after 1-year follow-up. These scans and radiographs will
             be assessed by a consensus panel of two academic endodontists in the department of
             Esthetic and restorative dentistry.
  
             A customized case sheet was prepared to be filled before starting with the treatment,
             after getting patient approval on participation in the study and signature the consent
             form. Case sheets and consent forms in Arabic and English languages are in the last
             pages in this protocol.
  
             3.2. Sample size calculation: This study was designed to have 80% power with an alpha
             margin of error of 5%, the sample size was calculated using G-power to detect an
             expected difference of 25% in failed outcomes between the two groups after one year of
             follow-up, a total sample size of 84 root canal treatments in two groups (each group =
             42) was calculated anticipating 10% loss of follow-up after one year.
  
             Cases selection:
  
             Inclusion criteria: mature maxillary and mandibular (first molars, first, and second
             premolars) that have clinical signs and symptoms of irreversible pulpitis or necrotic
             pulps that may or may not show apical periodontitis or chronic apical lesions on the
             preoperative CBCT scan or periapical radiograph.
  
             Exclusion criteria: pregnancy, immunosuppression, patients received radiotherapy,
             unrestorable teeth, teeth with periodontal probing depths greater than 3 mm,
             uncontrolled periodontal disease, presence of airways disease or allergy, vertical root
             fractures, signs of root resorption, or patient age over 70 years old.
  
             3.4. Randomization and patients Grouping: Block randomization will be performed using
             computer software, the tooth will be the unit of randomization. The following factors
             will be equalized during the allocation of teeth to the study arms: Gender
             (male/female), Age median, tooth type (molar/premolar), periapical lesion
             (presence/absence).
  
             Materials and Equipment:
  
             List of materials:
  
             1. Barbed broaches (Dentsply Maillefer, USA). 2. Disposable nitril gloves (Provi,
             Malaysia). 3. Disposable syringe 5ml (Malaysia) 4. EDTA solution 17% (Produits Dentaires
             SA, Switzerland) 5. Glyde (Dentsply, Sirona). 6. Bioceramic root canal sealer (BioRoot
             ™Flow, Septodont). 7. K-files #10 (Dentsply Maillefer, Switzerland). 8. K-files #15
             (Dentsply Maillefer, Switzerland). 9. NAOCL 5.25 % (Cerkamed, Poland). 10. Protaper Gold
             rotary files (Dentsply, Sirona). 11. Transfer sponges (Dentsply Maillefer, Switzerland).
             12. Irrigation needles 0.3 x 25(Cerkamed, Poland). 13. Normal saline. 14. Paper point
             (Dentsply, Maillefer, Switzerland). 15. Dam sheets (Sanctuary). 16. Gutta percha cones
             (Dentsply Maillefer, Switzerland). 17. Burs (Endo Z).
  
             Instruments:
  
               1. Diagnostic instruments (mirror, probe, and Tweezers) (Medesey, Italy).
  
               2. Rubber Dam kit.
  
               3. Endodontic plugger (Medesey, Italy)
  
               4. Endodontic ruler (Dentsply, Sirona).
  
               5. Ultrasonic Endotips.
  
               6. Ethyl chloride and electric pulp tester.
  
             Equipment:
  
               1. X-Smart IQ Cordless Endodontic Motor (Dentsply, Sirona).
  
               2. High-speed handpiece (Bien Air, Optima, Switzerland).
  
               3. Low-speed handpiece (NSK, Japan)
  
               4. Apex locator (NSK, Apex II, Japan).
  
               5. An ultrasonic scaler (Ultramint & Ultramint Pro, Eighteeth).
  
             Endodontic procedure:
  
             1. Tooth Preparation: An individual patient's data, including case history, clinical and
             radiological assessment, treatment plan and periodic follow-up of the patients will be
             recorded. Preoperative CBCT and periapical radiograph will be taken for each patient
             before starting the treatment. The time required for complete endodontic procedure will
             be recorded from the start of treatment for each case. Following anesthesia caries
             removal will be performed and restorability will be confirmed. In case of missing walls
             (Class II) cavity, pre-endodontic build-up will be performed. With rubber dam isolation,
             endodontic treatment will be started, after a straight-line access cavity is prepared by
             maintaining standard protocol, with confirmation of patency with size 8 and 10 k files.
             Working length will be confirmed with an electronic apex locator and radiograph, canals
             will be enlarged using Protaper Gold file system to Size F2 at minimum and for MB2 size
             F2 will be considered the master apical file with 2% sodium hypochlorite irrigation
             throughout the procedure, finally, the irrigant will be left in the canal and activated
             by smooth ultrasonic file (size 15, 0.02 taper) that placed into the canal to 1 mm short
             of the WL without touching the walls, enabling it to vibrate freely for 1 min (Hegde and
             Arora, 2015). Then final irrigation was done with 17% liquid ethylenediamine tetra
             acetic acid (17%EDTA) to remove the smear layer then irrigation with 2.5% NaOCl solution
             was placed and agitated for 60 seconds followed by a final irrigation with 1 mL of
             saline solution (Tavares, 2020). The canals will be dried with paper point, and master
             cone (gutta-percha) to be selected depending on master apical file for canals.
             Obturation will be performed with bioceramic sealer (BC) using single cone technique.
  
             2 Bacterial Count (Sample Collection): During sample collection, a sterile absorbent
             paper points size F2 will be introduced individually in the pulp chamber space before
             access cavity preparation and remained in this position for 60 seconds. After this, the
             paper point will be stored in a sterile microtube (2 mL) containing 1 mL pyrogenic water
             for subsequent microbiological analysis of Colony Forming Unit (CFU). This will be
             considered the base line measurement. After access cavity preparation and
             instrumentation, the second paper point will be inserted in the root canal space and
             remain in this position for 60 seconds and then will be stored in a sterile microtube (2
             mL) containing 1 mL pyrogenic water for subsequent microbiological analysis of Colony
             Forming Unit (CFU). This will be regarded as a second measurement for comparison
             purposes.
  
             3. Obturation BC sealer is chosen to be used in this study as it has exceptional
             dimensional stability and does not shrink upon setting; it is non-resorbable inside root
             canal. Furthermore, the formation of calcium hydroxide as a by-product of the setting
             reaction (initiated by moisture present in dentinal tubules) produces a very high
             alkaline pH (12.8) rendering the material antibacterial. It exhibits excellent
             biocompatibility; significant stimulation of periodontal regeneration and it is
             osteoconductive. All teeth will be referred back for final restoration within 1 month.
  
             Bioceramic root canal sealer is supplied in premix tube with disposable tips of narrow
             caliber. The syringe cap is to be removed from the syringe and intra canal tip to be
             attached with a clockwise twist to the hub of the syringe. Sealer will be injected into
             the coronal half of the canal and premeasured master gutta-percha (GP) point will be
             inserted it into the canal very slowly. GP carried sufficient sealer to the apex. Excess
             GP points will be removed from the pulp chamber by a heated plugger.
  
             4. Review of patients: Patients will be reviewed with a clinical and radiographic
             examination, one year after treatment. During this examination, CBCT will be taken using
             the same exposure settings as the initial scan.
  
             5. Radiographic assessment: Two examiners who had not been involved in clinical
             examination or treatment of patients will assess all the CBCT scans. Preoperative and
             follow-up CBCT images will be assessed for the presence of apical periodontitis, and
             dimension of periapical lesion.
  
             The assessment will be carried out on the coronal and sagittal slices at the equatorial
             level of the tooth of interest.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: The absence of clinical signs and symptoms in participants.
  time frame: 1 year
  description: (pain, tenderness to percussion, sinus tract, swelling).
  arm group label: Conservative Access Opening
  arm group type: Experimental
  description: Root canal treatment using Conservative Access Opening type.
  arm group label: Traditional Access Opening
  arm group type: Experimental
  description: Root canal treatment using Traditional Access Opening type.
  intervention type: Procedure
  intervention name: Conservative Access Opening, Traditional Access Opening
  description: Conservative Access Opening will be used and evaluated for cleaning ability versus Traditional Access Opening.
  arm group label: Conservative Access Opening
  arm group label: Traditional Access Opening
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahmed H Ali, Ph.D
  role: Study Director
  affiliation: University of Baghdad
  facility: 
  country: Iraq
  responsible party type: Principal Investigator
  investigator affiliation: University of Baghdad
  investigator full name: Ahmed Alani
  investigator title: Principal Investigator
  sharing ipd: No
  ipd description: CBCTs