search
Back to results

Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite

Primary Purpose

Dental Pulp Necrosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
1.3% NaOCl
5.25% NaOCl
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Pulp Necrosis

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: 25-45 year old.
  2. Medically free.
  3. Non-vital mandibular teeth (first or second molar) with or without apical periodontitis
  4. No sex predilection

Exclusion Criteria:

  1. Pregnant females.
  2. History of allergy to any medication used in the study.
  3. Preoperative premedication 12 hours before procedure.
  4. Acute abscess cases.
  5. Badly-decayed crown.
  6. Retreatment cases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1.3% NaOCl

    5.25% NaOCl

    Arm Description

    Root canal irrigation done using 1.3% NaOCl.

    Root canal irrigation done using 5.25% NaOCl.

    Outcomes

    Primary Outcome Measures

    Postoperative pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after the first visit
    Postoperative pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 3 hours after the first visit
    Postoperative pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the first visit
    Postoperative pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the first visit
    Postoperative pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit
    Postoperative pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after obturation.

    Secondary Outcome Measures

    Sham medication intake incidence
    Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain.
    Analgesic medication intake incidence
    Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.

    Full Information

    First Posted
    December 24, 2018
    Last Updated
    December 31, 2018
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03792217
    Brief Title
    Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite
    Official Title
    Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2011 (Actual)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2015 (Actual)

    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 was to evaluate the effect of 1.3% sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative pain and medication intake in adult patients with pulp necrosis in mandibular molars.
    Detailed Description
    The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3% sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative pain and medication intake in adult patients with pulp necrosis in mandibular molars. Medical and dental history was obtained from all participants in this trial and clinical and radiographic evaluation for teeth was recorded. Participants with pulp necrosis with or without apical periodontitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (irrigation using 1.3% NaOCl) or control group (irrigation using 5.25% NaOCl ). Two-visit root canal treatment was performed with a week interval in between visits. Each patient received a 7-day diary to record postoperative pain and rescue medication intake. Post-operative pain was measured at the following time points: immediately , 3, 24, 48 hours and 7 days after the first visit and postobturation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Pulp Necrosis

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1.3% NaOCl
    Arm Type
    Experimental
    Arm Description
    Root canal irrigation done using 1.3% NaOCl.
    Arm Title
    5.25% NaOCl
    Arm Type
    Active Comparator
    Arm Description
    Root canal irrigation done using 5.25% NaOCl.
    Intervention Type
    Other
    Intervention Name(s)
    1.3% NaOCl
    Other Intervention Name(s)
    1.3% sodium hypochlorite
    Intervention Description
    Endodontic irrigant
    Intervention Type
    Other
    Intervention Name(s)
    5.25% NaOCl
    Other Intervention Name(s)
    5.25% sodium hypochlorite
    Intervention Description
    Endodontic irrigant
    Primary Outcome Measure Information:
    Title
    Postoperative pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after the first visit
    Time Frame
    immediately after treatment
    Title
    Postoperative pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 3 hours after the first visit
    Time Frame
    3 hours
    Title
    Postoperative pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the first visit
    Time Frame
    24 hours
    Title
    Postoperative pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the first visit
    Time Frame
    48 hours
    Title
    Postoperative pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit
    Time Frame
    7 days
    Title
    Postoperative pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after obturation.
    Time Frame
    immediately after obturation
    Secondary Outcome Measure Information:
    Title
    Sham medication intake incidence
    Description
    Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain.
    Time Frame
    7 days
    Title
    Analgesic medication intake incidence
    Description
    Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: 25-45 year old. Medically free. Non-vital mandibular teeth (first or second molar) with or without apical periodontitis No sex predilection Exclusion Criteria: Pregnant females. History of allergy to any medication used in the study. Preoperative premedication 12 hours before procedure. Acute abscess cases. Badly-decayed crown. Retreatment cases
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suzan Amin, PhD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Randa El-Boghdady, PhD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22985896
    Citation
    Almeida G, Marques E, De Martin AS, da Silveira Bueno CE, Nowakowski A, Cunha RS. Influence of irrigating solution on postoperative pain following single-visit endodontic treatment: randomized clinical trial. J Can Dent Assoc. 2012;78:c84.
    Results Reference
    background
    PubMed Identifier
    21187618
    Citation
    Bashetty K, Hegde J. Comparison of 2% chlorhexidine and 5.25% sodium hypochlorite irrigating solutions on postoperative pain: a randomized clinical trial. Indian J Dent Res. 2010 Oct-Dec;21(4):523-7. doi: 10.4103/0970-9290.74225.
    Results Reference
    background
    PubMed Identifier
    28134983
    Citation
    Farzaneh S, Parirokh M, Nakhaee N, Abbott PV. Effect of two different concentrations of sodium hypochlorite on postoperative pain following single-visit root canal treatment: a triple-blind randomized clinical trial. Int Endod J. 2018 Jan;51 Suppl 1:e2-e11. doi: 10.1111/iej.12749. Epub 2017 Mar 6.
    Results Reference
    background

    Learn more about this trial

    Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite

    We'll reach out to this number within 24 hrs