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Effect of Diode Laser Activated Irrigation Versus Ultrasonic on Post-Operative Pain in Single Visit of Necrotic Teeth

Primary Purpose

Necrosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
diode laser activated irrigation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrosis focused on measuring Diode laser, asymptomatic pulp, Laser activated irrigation, continuous ultrasonic activation, post obturation pain

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Asymptomatic necrotic single rooted single canal teeth with or without chronic periradicular lesion.
  • Teeth with mature root
  • Teeth without calcified root canals
  • Teeth without root caries
  • Teeth without internal or external root resorption
  • Teeth with no sign of crack formation
  • Teeth without anatomic abnormalities

Exclusion Criteria:

  • Pregnant or lactating females
  • Teeth with vital pulp
  • Non- restorable teeth
  • Medically compromised patients
  • Patients with facial swelling or acute infection.
  • Previously endodontically treated teeth
  • periodontally affected teeth

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    diode laser activated irrigation

    ultrasonic activated irrigation

    Arm Description

    Laser-activated irrigation (LAI) has been introduced as a powerful method enhancing irrigant action; The laser radiation produces transient cavitation in the liquid through optical breakdown by strong absorption of the laser energy. The high-power diode laser has been tested in several areas of dentistry such as bleaching, depigmentation and gingivectomy, with promising results in dentinal disinfection. The diode laser has proved to be a resource worth testing, because of the it's properties and its low cost and availability in comparison to most lasers used in endodontics.

    ultrasonics have been developed to improve the penetration and effectiveness of irrigation in peripheral areas of the root canal space. The efficiency of sonic and ultrasonic devices is based on the creation of hydrodynamic phenomenon in well-shaped canals filled with an irrigant. Such active root canal irrigation has been shown to facilitate the disruption of biofilms and make the cell membrane of bacteria more permeable to NaOCl.

    Outcomes

    Primary Outcome Measures

    post operative pain
    intensity of post operative pain will be measured using a numerical rating (NRS)scale

    Secondary Outcome Measures

    Full Information

    First Posted
    January 4, 2017
    Last Updated
    January 10, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03015987
    Brief Title
    Effect of Diode Laser Activated Irrigation Versus Ultrasonic on Post-Operative Pain in Single Visit of Necrotic Teeth
    Official Title
    The Effect of Diode Laser Activated Irrigation Versus Ultrasonic Activated Irrigation on Post-Operative Pain in Single Visit Endodontic Treatment of Asymptomatic Necrotic Teeth: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2017 (undefined)
    Primary Completion Date
    January 2018 (Anticipated)
    Study Completion Date
    February 2018 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    the investigator intended to study the effect of laser versus ultrasonic in activation of irrigation in post operative pain of patients have a symptomatic necrotic teeth
    Detailed Description
    the investigator will choose from patients entering clinic of endodontics in faculty of oral and dental medicine Cairo university who are eligible to the criteria. After the patients is found eligible,the patients will be randomly assigned to either the control (ultrasonic activated irrigation )or to the intervention ( diode laser activated irrigation) treatment done in both in single visit. At the end of treatment, patients will be asked to record post operative pain by NRS .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrosis
    Keywords
    Diode laser, asymptomatic pulp, Laser activated irrigation, continuous ultrasonic activation, post obturation pain

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    diode laser activated irrigation
    Arm Type
    Experimental
    Arm Description
    Laser-activated irrigation (LAI) has been introduced as a powerful method enhancing irrigant action; The laser radiation produces transient cavitation in the liquid through optical breakdown by strong absorption of the laser energy. The high-power diode laser has been tested in several areas of dentistry such as bleaching, depigmentation and gingivectomy, with promising results in dentinal disinfection. The diode laser has proved to be a resource worth testing, because of the it's properties and its low cost and availability in comparison to most lasers used in endodontics.
    Arm Title
    ultrasonic activated irrigation
    Arm Type
    Active Comparator
    Arm Description
    ultrasonics have been developed to improve the penetration and effectiveness of irrigation in peripheral areas of the root canal space. The efficiency of sonic and ultrasonic devices is based on the creation of hydrodynamic phenomenon in well-shaped canals filled with an irrigant. Such active root canal irrigation has been shown to facilitate the disruption of biofilms and make the cell membrane of bacteria more permeable to NaOCl.
    Intervention Type
    Other
    Intervention Name(s)
    diode laser activated irrigation
    Other Intervention Name(s)
    diode laser
    Intervention Description
    diode laser became the most common and affordable type of laser used in endodontics for many uses , its disinfection effect is an important issue which not discussed in clinical trial before , So this study is assigned to study that
    Primary Outcome Measure Information:
    Title
    post operative pain
    Description
    intensity of post operative pain will be measured using a numerical rating (NRS)scale
    Time Frame
    up to 1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Asymptomatic necrotic single rooted single canal teeth with or without chronic periradicular lesion. Teeth with mature root Teeth without calcified root canals Teeth without root caries Teeth without internal or external root resorption Teeth with no sign of crack formation Teeth without anatomic abnormalities Exclusion Criteria: Pregnant or lactating females Teeth with vital pulp Non- restorable teeth Medically compromised patients Patients with facial swelling or acute infection. Previously endodontically treated teeth periodontally affected teeth
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zeinab M Omar, student
    Phone
    01017111154
    Email
    dentistonline89@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ghada A Eid, Professor
    Phone
    01001266608
    Email
    ghada.eid@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ghada A Eid, Professor
    Organizational Affiliation
    Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Hanaa M El shinawy, Researcher professor
    Organizational Affiliation
    Surgery &oral medicine department -National Research Institute-Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Zeinab M Omar, Student
    Organizational Affiliation
    Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    1-Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J 2008; 41:91-9. 2-.Ng YL, Glennon JP, Setchell DJ. Prevalence of and factors affecting post. obturation pain in patients undergoing root canal treatment. Int Endod J 2004;37:381-91. 3-Peters OA. Current challenges and concepts in the preparation of root canal systems a review. J Endod 2004; 30:559-67. 4- Gu L, Kim JR, Ling J. Review of contemporary irrigant agitation techniques and devices. J Endod 2009; 35:791-804.
    Results Reference
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    Effect of Diode Laser Activated Irrigation Versus Ultrasonic on Post-Operative Pain in Single Visit of Necrotic Teeth

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