Influence of Irrigant Delivery Systems on the Incidence of Postoperative Discomfort in Oval Canals
1 other identifier
interventional
32
1 country
1
Brief Summary
The main aim of endodontic therapy is to disinfect the entire root canal system (RCS), which requires the elimination of microorganisms and microbial components. This goal is pursued by chemo-mechanical debridement of the RCS. Attaining this goal remains challenging due to the complex and variable anatomy of the root canal system, which includes intricate structures such as fins, isthmuses, lateral canals, and apical deltas that are often inaccessible to mechanical instrumentation. To overcome these anatomical limitations, various irrigation protocols have been developed to enhance the penetration and effectiveness of irrigating solutions.The use of different activation techniques-such as manual dynamic agitation, irrigation needle, sonic and ultrasonic activation, and negative pressure irrigation systems-aims to improve the distribution, exchange, and cleaning ability of irrigants within hard-to-reach areas of the canal system.These approaches are designed to maximize microbial reduction and promote more effective removal of debris and smear layer remnants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
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
Study Start
First participant enrolled
April 14, 2026
CompletedFirst Submitted
Initial submission to the registry
August 16, 2026
CompletedFirst Posted
Study publicly available on registry
August 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 14, 2027
August 26, 2026
April 1, 2026
12 months
August 16, 2026
August 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative pain
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 will indicate "no pain" and 10 will indicate "worst imaginable pain." Participants will be instructed to record their pain intensity at 6, 12, 24, 48,and 72 hours, and on the 7th day after treatment. All recorded pain scores will be collected for statistical analysis and comparison among the study groups
7 Days
Study Arms (4)
Group of Sodium hypochlorite
ACTIVE COMPARATORAbout 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% as irrigating solution used as 20 mL irrigant per canal \& EDDY sonic activation tips (Device)
Group of Safe Clean system (Device)
ACTIVE COMPARATORAbout 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% \& Apical Negative Pressure Irrigation using Safe Clean system
Group of Sodium hypochlorite & manual agitation technique
ACTIVE COMPARATORAbout 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% \& manual agitation technique with apical master gutta percha cone (Device)
Group of Sodium Hypochlorite & Side vented needle (Device)
ACTIVE COMPARATORAbout 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% \& side vented needle (Device)
Interventions
to compare the effect of all different irrigation and activation protocols manual agitation, conventional needle irrigation, sonic activation, and negative pressure systems (such as Safe Clean) on the incidence and intensity of postoperative pain following endodontic treatment of canines and premolars
Eligibility Criteria
You may qualify if:
- Patients requiring primary root canal treatment.
- Patients in good general health..
- Subjects classified as ASA-1 following the classification proposed by the American Society of Anesthesiologists.
You may not qualify if:
- Patients with systemic diseases affecting pain perception or healing.
- Patients who had taken analgesics or antibiotics within 12-24 hours prior to treatment.
- Pregnant or lactating women.
- Previously treated teeth or teeth with root resorption, fractures, or severe periodontal disease. .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Endodontics Department Faculty of Dentistry
Minya, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dalia Ali Ahmed Moukarab, M.D
Professor and Head of the Endodontics Department, Faculty of Dentistry
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident at department of Endodontics, Faculty of Dentistry
Study Record Dates
First Submitted
August 16, 2026
First Posted
August 26, 2026
Study Start
April 14, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 14, 2027
Last Updated
August 26, 2026
Record last verified: 2026-04