search
Back to results

Effect of Apical Enlargement to Different Preparation Sizes and Tapers on Pain and Bacterial Reduction in Necrotic Pulp

Primary Purpose

Necrotic Pulp

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Root canal instrumentation EdgeFile X7 to size #35/0.06
Root canal instrumentation EdgeFile X7 to size #45/0.04
Root canal instrumentation EdgeFile X7 to size #45/0.06
Root canal instrumentation EdgeFile X7 to size #35/0.04
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Necrotic Pulp focused on measuring Apical enlargement, Postoperative pain, Intra-canal bacterial reduction, Preparation taper, EdgeFile X7

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Systemically healthy patients, American Society of Anesthesiologists (ASA) I and II. Patient's age ranges between 18 to 35 years with no sex predilection. Patients with single-rooted mandibular premolars with asymptomatic necrotic pulp. Patients who can understand the Numerical Rating Scale (NRS). Patients able to sign informed consent. Exclusion Criteria: Pregnant females. Mandibular premolars with periodontal pockets greater than 5 mm or greater than grade I mobility. Patients have a positive history of antibiotic use or analgesic use within the past week or required antibiotic premedication for dental treatment (such as prosthetic joint prophylaxis). Patients have teeth that have been previously accessed. Teeth with extensive crown destruction by caries that will not permit rubber dam placement. Teeth associated with acute periapical abscess, swelling or a fistulous tract. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Root canal instrumentation EdgeFile X7 to size #35/0.06

    Root canal instrumentation EdgeFile X7 to size #45/0.04

    Root canal instrumentation EdgeFile X7 to size #45/0.06

    Root canal instrumentation EdgeFile X7 to size #35/0.04

    Arm Description

    The mechanical preparation will be continued using EdgeFile X7 #35 .04 and #35 .06

    The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04 and #45 .04

    The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04, #45 .04 and #45 .06

    The mechanical preparation will be continued using EdgeFile X7 #35 .04

    Outcomes

    Primary Outcome Measures

    Post-operative pain
    Postendodontic pain will be measured using Numerical Rating Scale. The Numerical Rating Scale consists of a 0-10 scale, with (0) meaning "no pain" and (10) meaning "the worst pain imaginable". No or mild pain response will be considered success.

    Secondary Outcome Measures

    Intra-canal bacterial reduction
    Intra-canal bacterial count will be measured using a culture technique. The resultant growth will be visually quantified by counting the number of colony forming units per millilitre (CFUs/ mL)

    Full Information

    First Posted
    November 2, 2022
    Last Updated
    November 16, 2022
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05620147
    Brief Title
    Effect of Apical Enlargement to Different Preparation Sizes and Tapers on Pain and Bacterial Reduction in Necrotic Pulp
    Official Title
    Effect of Apical Third Enlargement to Different Preparation Sizes and Tapers of EdgeFile X7 on Postoperative Pain and Intra-canal Bacterial Reduction in Patients With Necrotic Pulp: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this prospective randomized clinical trial is to evaluate the effect of different apical size and taper preparation (35. 04; 35. 06; 45. 04 and 45. 06) on postoperative pain at 6, 12, 24, 48 and 72 hours, and intra-canal bacterial count in patients having mandibular premolars with necrotic pulps.
    Detailed Description
    Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit. Patients will be randomly assigned to one of 4 groups: experimental groups of root canal instrumentation with EdgeFile X7 to size #35/0.06 or #45/0.04 or #45/0.06 or the comparator group to size #35/0.04. Intra-canal bacterial count will be measured using a culture technique. Bacterial samples will be taken before and after root canal instrumentation. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 400 mg as rescue medication. Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed at 6, 12, 24, 48 and 72 hours postoperatively using Numerical Rating Scale (NRS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrotic Pulp
    Keywords
    Apical enlargement, Postoperative pain, Intra-canal bacterial reduction, Preparation taper, EdgeFile X7

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Root canal instrumentation EdgeFile X7 to size #35/0.06
    Arm Type
    Experimental
    Arm Description
    The mechanical preparation will be continued using EdgeFile X7 #35 .04 and #35 .06
    Arm Title
    Root canal instrumentation EdgeFile X7 to size #45/0.04
    Arm Type
    Experimental
    Arm Description
    The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04 and #45 .04
    Arm Title
    Root canal instrumentation EdgeFile X7 to size #45/0.06
    Arm Type
    Experimental
    Arm Description
    The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04, #45 .04 and #45 .06
    Arm Title
    Root canal instrumentation EdgeFile X7 to size #35/0.04
    Arm Type
    Active Comparator
    Arm Description
    The mechanical preparation will be continued using EdgeFile X7 #35 .04
    Intervention Type
    Other
    Intervention Name(s)
    Root canal instrumentation EdgeFile X7 to size #35/0.06
    Other Intervention Name(s)
    EdgeEndo
    Intervention Description
    Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
    Intervention Type
    Other
    Intervention Name(s)
    Root canal instrumentation EdgeFile X7 to size #45/0.04
    Other Intervention Name(s)
    EdgeEndo
    Intervention Description
    Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
    Intervention Type
    Other
    Intervention Name(s)
    Root canal instrumentation EdgeFile X7 to size #45/0.06
    Other Intervention Name(s)
    EdgeEndo
    Intervention Description
    Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
    Intervention Type
    Other
    Intervention Name(s)
    Root canal instrumentation EdgeFile X7 to size #35/0.04
    Other Intervention Name(s)
    EdgeEndo
    Intervention Description
    Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
    Primary Outcome Measure Information:
    Title
    Post-operative pain
    Description
    Postendodontic pain will be measured using Numerical Rating Scale. The Numerical Rating Scale consists of a 0-10 scale, with (0) meaning "no pain" and (10) meaning "the worst pain imaginable". No or mild pain response will be considered success.
    Time Frame
    up to 72 hours after endodontic treatment
    Secondary Outcome Measure Information:
    Title
    Intra-canal bacterial reduction
    Description
    Intra-canal bacterial count will be measured using a culture technique. The resultant growth will be visually quantified by counting the number of colony forming units per millilitre (CFUs/ mL)
    Time Frame
    Bacterial samples will be taken Immediately after root canal instrumentation.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Systemically healthy patients, American Society of Anesthesiologists (ASA) I and II. Patient's age ranges between 18 to 35 years with no sex predilection. Patients with single-rooted mandibular premolars with asymptomatic necrotic pulp. Patients who can understand the Numerical Rating Scale (NRS). Patients able to sign informed consent. Exclusion Criteria: Pregnant females. Mandibular premolars with periodontal pockets greater than 5 mm or greater than grade I mobility. Patients have a positive history of antibiotic use or analgesic use within the past week or required antibiotic premedication for dental treatment (such as prosthetic joint prophylaxis). Patients have teeth that have been previously accessed. Teeth with extensive crown destruction by caries that will not permit rubber dam placement. Teeth associated with acute periapical abscess, swelling or a fistulous tract. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nermeen Ibrahim, Master's
    Phone
    01114323345
    Ext
    002
    Email
    nermin.awadallah@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nermeen Ibrahim, Master's
    Organizational Affiliation
    Misr University for Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34058250
    Citation
    Fatima S, Kumar A, Andrabi SMUN, Mishra SK, Tewari RK. Effect of Apical Third Enlargement to Different Preparation Sizes and Tapers on Postoperative Pain and Outcome of Primary Endodontic Treatment: A Prospective Randomized Clinical Trial. J Endod. 2021 Sep;47(9):1345-1351. doi: 10.1016/j.joen.2021.05.010. Epub 2021 May 29.
    Results Reference
    background
    PubMed Identifier
    28483164
    Citation
    Rodrigues RCV, Zandi H, Kristoffersen AK, Enersen M, Mdala I, Orstavik D, Rocas IN, Siqueira JF Jr. Influence of the Apical Preparation Size and the Irrigant Type on Bacterial Reduction in Root Canal-treated Teeth with Apical Periodontitis. J Endod. 2017 Jul;43(7):1058-1063. doi: 10.1016/j.joen.2017.02.004. Epub 2017 May 5.
    Results Reference
    background

    Learn more about this trial

    Effect of Apical Enlargement to Different Preparation Sizes and Tapers on Pain and Bacterial Reduction in Necrotic Pulp

    We'll reach out to this number within 24 hrs