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
About this trial
This is an interventional prevention trial for Dental Pulp Necrosis
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
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
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
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Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite
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