Post Operative PainNCT07788027
Influence of Irrigant Delivery Systems on the Incidence of Postoperative Discomfort in Oval Canals
A study testing Sodium hypochlorite 5.25% in people with Post Operative Pain, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Sodium hypochlorite 5.25%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Apr 2026to 14 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Endodontics Department Faculty of Dentistry
Minya
Mohamed Abdel Mawla Mohamed Morsi, Lecturer, +201005757045, Dr.mohammed.abdelmawla@gmail.com
About this study
Official title: Influence of Irrigant Delivery Systems on the Incidence of Postoperative Discomfort in Oval Canals : A Randomized Clinical 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.
Read the detailed description
Despite their proven efficacy in improving canal cleanliness and disinfection, these irrigation protocols are not without drawbacks. Mechanical and chemical interactions may lead to extrusion of irrigants or debris beyond the apical foramen, potentially causing irritation of the periapical tissues. As a result, patients may experience varying degrees of postoperative pain or discomfort following treatment, depending on the irrigation method and activation technique employed.
Manual Agitation:
Manual agitation is a simple and cost-effective method used to enhance irrigant penetration and exchange within the root canal system. It involves the use of instruments such as gutta-percha cones or endodontic brushes to manually move the irrigant inside the canal. Although this technique can improve irrigant distribution, its effectiveness is limited by the operator's ability and the lack of continuous flow or activation energy, making it less efficient in complex canal anatomies.
Conventional Needle Irrigation:
Conventional needle irrigation remains the most widely practiced method of delivering irrigants into the canal. Typically, side-vented or open-ended needles are used to dispense the solution within 1-2 mm of the working length. While this technique allows controlled delivery, its major limitation lies in the restricted penetration of irrigant into irregularities and apical areas due to vapor lock and inadequate fluid replacement. Consequently, canal cleanliness and disinfection depend heavily on the needle design, placement depth, and flow rate.
Sonic and Ultrasonic Activation:
Sonic and ultrasonic activation techniques utilize energy transmitted through oscillating tips or files to enhance the dynamic movement of irrigants within the canal. Sonic devices operate at lower frequencies (1-10 kHz), generating acoustic streaming that improves debris removal. Ultrasonic systems function at higher frequencies (25-40 kHz), producing vigorous cavitation and acoustic streaming effects that significantly enhance the cleaning and disinfecting potential of irrigants. However, excessive activation or improper use may increase the risk of irrigant extrusion and subsequent postoperative discomfort.
Negative Pressure Irrigation:
Negative pressure systems, such as the EndoVac or SafeClean, were developed to minimize the risk of apical extrusion and improve irrigant exchange in the apical third.These systems deliver irrigant from the coronal portion while simultaneously applying negative pressure to draw the solution down the canal and aspirate it at the apex. This design enables effective irrigation of the apical region while maintaining safety and preventing periapical irritation.There is limited clinical evidence comparing the effect of different irrigation/activation protocols on postoperative pain in canines and premolars .
- Conditions
- Post Operative Pain
- Being tested
- Sodium hypochlorite 5.25%
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hypochlorite 5.25%Drug
Also called Sonic activation, and negative pressure systems
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
| Study group | Role | What they receive |
|---|---|---|
| Group of Sodium hypochlorite | Active comparator | About 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) Receives: Drug: Sodium hypochlorite 5.25% |
| Group of Safe Clean system (Device) | Active comparator | About 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 Receives: Drug: Sodium hypochlorite 5.25% |
| Group of Sodium hypochlorite & manual agitation technique | Active comparator | About 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) Receives: Drug: Sodium hypochlorite 5.25% |
| Group of Sodium Hypochlorite & Side vented needle (Device) | Active comparator | About 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% \& side vented needle (Device) Receives: Drug: Sodium hypochlorite 5.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start14 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion14 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Sayid Mohammed, Minia University
- Investigators
- Dalia Ali Ahmed Moukarab, M.D, Study chair, Professor and Head of the Endodontics Department, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788027
- Sponsor's protocol ID
- Discomfort in oval canals
- Status last verified
- Apr 2026
- First submitted
- 16 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Irrigant Delivery Systems on the Incidence of Postoperative Discomfort in Oval Canals : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07788027
- Acronym / sponsor ID
- Discomfort in oval canals
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 14 Apr 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite their proven efficacy in improving canal cleanliness and disinfection, these irrigation protocols are not without drawbacks. Mechanical and chemical interactions may lead to extrusion of irrigants or debris beyond the apical foramen, potentially causing irritation of the periapical tissues. As a result, patients may experience varying degrees of postoperative pain or discomfort following treatment, depending on the irrigation method and activation technique employed.
Manual Agitation:
Manual agitation is a simple and cost-effective method used to enhance irrigant penetration and exchange within the root canal system. It involves the use of instruments such as gutta-percha cones or endodontic brushes to manually move the irrigant inside the canal. Although this technique can improve irrigant distribution, its effectiveness is limited by the operator's ability and the lack of continuous flow or activation energy, making it less efficient in complex canal anatomies.
Conventional Needle Irrigation:
Conventional needle irrigation remains the most widely practiced method of delivering irrigants into the canal. Typically, side-vented or open-ended needles are used to dispense the solution within 1-2 mm of the working length. While this technique allows controlled delivery, its major limitation lies in the restricted penetration of irrigant into irregularities and apical areas due to vapor lock and inadequate fluid replacement. Consequently, canal cleanliness and disinfection depend heavily on the needle design, placement depth, and flow rate.
Sonic and Ultrasonic Activation:
Sonic and ultrasonic activation techniques utilize energy transmitted through oscillating tips or files to enhance the dynamic movement of irrigants within the canal. Sonic devices operate at lower frequencies (1-10 kHz), generating acoustic streaming that improves debris removal. Ultrasonic systems function at higher frequencies (25-40 kHz), producing vigorous cavitation and acoustic streaming effects that significantly enhance the cleaning and disinfecting potential of irrigants. However, excessive activation or improper use may increase the risk of irrigant extrusion and subsequent postoperative discomfort.
Negative Pressure Irrigation:
Negative pressure systems, such as the EndoVac or SafeClean, were developed to minimize the risk of apical extrusion and improve irrigant exchange in the apical third.These systems deliver irrigant from the coronal portion while simultaneously applying negative pressure to draw the solution down the canal and aspirate it at the apex. This design enables effective irrigation of the apical region while maintaining safety and preventing periapical irritation.There is limited clinical evidence comparing the effect of different irrigation/activation protocols on postoperative pain in canines and premolars .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group of Sodium hypochlorite | Active comparator | Drug: Sodium hypochlorite 5.25%About 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 comparator | Drug: Sodium hypochlorite 5.25%About 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 comparator | Drug: Sodium hypochlorite 5.25%About 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 comparator | Drug: Sodium hypochlorite 5.25%About 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% \& side vented needle (Device) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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. .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium hypochlorite 5.25%Also: Sonic activation, and negative pressure systemsto 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 | Drug | Group of Safe Clean system (Device), Group of Sodium Hypochlorite & Side vented needle (Device), Group of Sodium hypochlorite, Group of Sodium hypochlorite & manual agitation technique |
Primary outcome
Post-operative pain
Time frame: 7 Days
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dalia Ali Ahmed Moukarab, M.D study chair
Professor and Head of the Endodontics Department, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium hypochlorite 5.25% in people with Post Operative Pain, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Sayid Mohammed, B.D.S (+201097391219, Nourhansayid02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.