Influence of Irrigant Delivery Systems on the Incidence of Postoperative Discomfort in Oval Canals

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorMinia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inclusion Criteria Patients aged between 18 and 45 years.

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.

Disqualifiers

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. .

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sodium hypochlorite 5.25%

    Drug

    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

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: Group of Sodium hypochloriteActive comparator 1 intervention
Group B: Group of Safe Clean system (Device)Active comparator 1 intervention
Group C: Group of Sodium hypochlorite & manual agitation techniqueActive comparator 1 intervention
Group D: Group of Sodium Hypochlorite & Side vented needle (Device)Active comparator 1 intervention

Trial outcomes

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

Time frame
7 Days

Secondary outcomes

Other outcomes

Sponsors and contacts

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