Different Concentrations of Sodium Hypochlorite Affecting Post-endodontic Pain
NaOCl
Effect of Different Concentrations of Sodium Hypochlorite on Post Operative Pain Following Single Visit Root Canal Treatment
1 other identifier
interventional
66
1 country
1
Brief Summary
This is a randomized, prospective, double-blind, clinical trial to assess the effect of 3% and 6% sodium hypochlorite (NaOCl) as irrigant on postendodontic pain and rescue medication intake following single visit root canal treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2023
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2023
CompletedStudy Start
First participant enrolled
April 30, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedMay 3, 2023
April 1, 2023
6 months
April 5, 2023
April 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative pain after root canal treatment
Post-operative pain will be assessed using a self-report questionnaire using a numerical visual analogue scale (VAS) from 0 to 10. 0 = No pain 1 - 3 = Mild pain 4 - 6 = Moderate pain 7 -10 = Severe pain Pain recording will be done after 6hrs, 12hrs, 24hrs, 48hrs and 72 hrs. (Participants to be contacted by the investigator at each time point to check on them and remind them to record their pain) The given questionnaire shall be collected when the participant comes for final restoration one week later.
1 week
Study Arms (2)
3% NaOCl concentration group
EXPERIMENTALParticipants in this group will receive endodontic irrigation with lower conc 3% sodium hypochlorite
6% NaOCl concentration group
EXPERIMENTALParticipants in this group will receive endodontic irrigation with higher conc 6% sodium hypochlorite
Interventions
Different concentrations of NaOCl are being used as the endodontic irrigant.
Eligibility Criteria
You may qualify if:
- Healthy individuals between 18 to 55 years
- First and second mandibular molar diagnosed with irreversible pulpitis due to caries
- Patients with moderate pain will be selected, VAS score (4 - 6).
- Normal periapical radiographic appearance
- Mild tender to percussion
- No allergies to articaine
You may not qualify if:
- Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit
- Pregnant or lactating patients
- Teeth with severe periodontal disease
- Teeth that cannot be isolated with rubber dam
- Teeth undergone over-instrumentation or overfilling beyond apex
- Teeth with calcifications/ resorptive defects
- History of allergy to any materials used in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Armed Forces Institue Of Dentistry
Rawalpindi, Punjab Province, 46000, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Kanza Zafar, Principal Investigator and Resident Operative Dentistry and Endodontics
Study Record Dates
First Submitted
April 5, 2023
First Posted
May 3, 2023
Study Start
April 30, 2023
Primary Completion
October 30, 2023
Study Completion
October 31, 2023
Last Updated
May 3, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share