Three Canal Irrigation Methods and Their ComparisonNCT07731594
Effectiveness of Three Different Irrigation Methods During a Root Canal Treatment
A study testing Conventional Needle, Side Vented Needle and Ultrasonic Irrigation in people with Three Canal Irrigation Methods and Their Comparison and Penetration of Irrigant in the Root Canal, run by Pakistan Institute of Medical Sciences.
Trial summary
This study aims to compare the effectiveness of three root canal irrigation techniques-Conventional Needle Irrigation (CNI), Side-Vented Needle (SVN), and Ultrasonic Irrigation (UI)-in achieving irrigant penetration into the apical third of the root canal. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Three Canal Irrigation Methods and Their Comparison, Penetration of Irrigant in the Root Canal
- What is being tested?
- Conventional Needle, Side Vented Needle and Ultrasonic Irrigation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 12 Jul 2026to 26 Dec 2026
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Straight Canals
- Single Rooted 1st and 2nd mandibular premolars with closed apices
Who cannot join
- Mandibular premolars with open apices
- Mandibular premolars with curved or calcified canals
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Various Irrigant Activation Methods and Its Penetration in the Apical Third of Root Canal
This study aims to compare the effectiveness of three root canal irrigation techniques-Conventional Needle Irrigation (CNI), Side-Vented Needle (SVN), and Ultrasonic Irrigation (UI)-in achieving irrigant penetration into the apical third of the root canal. Since conventional irrigation often fails to adequately clean complex root canal anatomy, the study evaluates whether activation methods improve irrigant penetration. A randomized controlled trial will compare these three techniques using extracted single-rooted mandibular premolars. A radiopaque dye mixed with sodium hypochlorite will be used to measure irrigant penetration on digital radiographs, and the results will be statistically analyzed to determine the most effective irrigation method.
Read the detailed description
This study focuses on evaluating the effectiveness of three different root canal irrigation techniques in achieving irrigant penetration into the apical third of the root canal. Successful root canal treatment depends not only on mechanical instrumentation but also on adequate irrigation to eliminate bacteria, dissolve organic tissue, and remove debris from areas that instruments cannot reach. Due to the complex anatomy of the root canal system, studies have shown that nearly 35% of the canal walls remain untouched after instrumentation. Therefore, irrigation plays a vital role in ensuring complete disinfection of the canal system. Furthermore, bacteria are capable of penetrating 300-500 micrometers into the dentinal tubules, making it essential for the irrigant to reach as deep as possible within the canal.
Conventionally, sodium hypochlorite is delivered into the canal using a syringe and needle. Although it is considered the gold standard irrigant because of its tissue-dissolving ability and broad-spectrum antimicrobial action, conventional needle irrigation has limitations. The irrigant generally does not travel beyond the tip of the needle, leaving the apical third and other complex areas inadequately cleaned. To overcome these shortcomings, newer irrigation activation methods such as side-vented needles and ultrasonic irrigation have been introduced to improve irrigant flow and penetration throughout the root canal system.
The purpose of this study is to compare three irrigation techniques-Conventional Needle Irrigation (CNI), Side-Vented Needle Irrigation (SVN), and Ultrasonic Irrigation (UI)-to determine which technique provides the deepest penetration of the irrigant into the apical third of the root canal. The hypothesis of the study is that ultrasonic irrigation, being an active irrigation technique, will result in significantly greater irrigant penetration than conventional needle irrigation and side-vented needle irrigation.
According to the synopsis, this study is designed as a randomized controlled trial and will be conducted in the Department of Operative Dentistry over a period of one year after approval. A total sample size of 105 teeth will be included, with 35 samples allocated to each of the three study groups. The study will include extracted single-rooted mandibular first and second premolars with straight canals and closed apices, while teeth with open apices, curved canals, or calcified canals will be excluded.
Initially, all selected teeth will be examined radiographically to exclude unsuitable samples. Standard access cavity preparation will then be carried out, followed by determination of the working length. The canals will be instrumented using the ProTaper rotary system up to file F3, while sodium hypochlorite will be used as the irrigating solution during instrumentation. After completion of canal preparation, the samples will be randomly assigned to one of the three irrigation groups: Conventional Needle Irrigation, Side-Vented Needle Irrigation, or Ultrasonic Irrigation.
To assess irrigant penetration, a radiopaque iohexol dye will be mixed with sodium hypochlorite. After irrigation using the assigned technique, digital radiographs will be obtained. The distance from the apical foramen to the deepest point reached by the radiopaque irrigant will be measured for each sample. This measurement will represent the depth of irrigant penetration achieved by each irrigation technique.
The collected data will be entered into Microsoft Excel and analyzed using SPSS version 23. Descriptive statistics, including the mean and standard deviation, will be calculated to compare the irrigant penetration among the three groups. Based on the study hypothesis, ultrasonic irrigation is expected to demonstrate the greatest penetration into the apical third of the root canal, suggesting that it may provide superior canal disinfection compared with conventional and side-vented needle irrigation. This expectation reflects the hypothesis stated in the synopsis rather than study results, as the research has not yet been conducted.
- Conditions
- Three Canal Irrigation Methods and Their Comparison, Penetration of Irrigant in the Root Canal
- Being tested
- Conventional Needle, Side Vented Needle, Ultrasonic Irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional NeedleProcedure or surgery
Conventional syringe irrigation will be performed using a 27-gauge needle to deliver the radiopaque sodium hypochlorite solution into the prepared root canal. No additional activation technique will be used during irrigation
Side Vented NeedleProcedure or surgery
Irrigation will be carried out using a side-vented needle to introduce the radiopaque sodium hypochlorite solution into the prepared canal. The side-vented design is intended to improve irrigant distribution within the canal while minimizing direct apical flow
Ultrasonic IrrigationProcedure or surgery
Following canal preparation, the radiopaque sodium hypochlorite solution will be activated using an ultrasonic device to enhance irrigant movement throughout the root canal system before radiographic evaluation of penetration depth.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Needle Irrigation | Active comparator | Participants in this group will receive root canal irrigation using a conventional 27-gauge syringe needle. The irrigant, consisting of a radiopaque iohexol dye mixed with 5.25% sodium hypochlorite, will be delivered into the prepared root canal using the conventional needle irrigation technique. Irrigant penetration into the apical third will be assessed using digital radiographs. Receives: Procedure: Conventional Needle |
| Side Vented Needle Irrigation | Active comparator | Participants in this group will receive root canal irrigation using a side-vented irrigation needle. The radiopaque irrigant solution, prepared by mixing iohexol dye with 5.25% sodium hypochlorite, will be delivered into the canal using the side-vented needle technique. Irrigant penetration into the apical third will be measured on digital radiographs. Receives: Procedure: Side Vented Needle |
| Ultrasonic Irrigation | Experimental | Participants in this group will receive ultrasonic irrigation following completion of canal preparation. A radiopaque irrigant solution consisting of iohexol dye mixed with 5.25% sodium hypochlorite will be ultrasonically activated within the root canal. Digital radiographs will be used to measure the depth of irrigant penetration into the apical third and compare it with the other irrigation techniques Receives: Procedure: Ultrasonic Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of irrigant penetration into the apical third of the root canal (measured in millimeters).
The primary outcome is the depth of penetration of a radiopaque irrigant solution into the apical third of the root canal following irrigation with Conventional Needle Irrigation (CNI), Side-Vented Needle Irrigation (SVN), or Ultrasonic Irrigation (UI). Penetration depth will be measured on digital radiographs as the distance from the apical foramen to the deepest point reached by the irrigant.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start12 Jul 2026 (estimated)
- Primary completion10 Nov 2026 (estimated)
- Study completion26 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Three Canal Irrigation Methods and Their ComparisonStudies of the same condition, open and under way.
- 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Haroon Hafeez, Pakistan Institute of Medical Sciences
- Investigators
- Haroon H Panezai, BDS, Principal investigator, School Of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731594
- Sponsor's protocol ID
- SOD/ERB/2025/89
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Various Irrigant Activation Methods and Its Penetration in the Apical Third of Root Canal
- ClinicalTrials.gov ID
- NCT07731594
- Acronym / sponsor ID
- SOD/ERB/2025/89
- Conditions
- Three Canal Irrigation Methods and Their Comparison, Penetration of Irrigant in the Root Canal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 12 Jul 2026 (estimated)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 26 Dec 2026 (estimated)
- First posted
- 28 Jul 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.
This study aims to compare the effectiveness of three root canal irrigation techniques-Conventional Needle Irrigation (CNI), Side-Vented Needle (SVN), and Ultrasonic Irrigation (UI)-in achieving irrigant penetration into the apical third of the root canal. Since conventional irrigation often fails to adequately clean complex root canal anatomy, the study evaluates whether activation methods improve irrigant penetration. A randomized controlled trial will compare these three techniques using extracted single-rooted mandibular premolars. A radiopaque dye mixed with sodium hypochlorite will be used to measure irrigant penetration on digital radiographs, and the results will be statistically analyzed to determine the most effective irrigation method.
Detailed description
This study focuses on evaluating the effectiveness of three different root canal irrigation techniques in achieving irrigant penetration into the apical third of the root canal. Successful root canal treatment depends not only on mechanical instrumentation but also on adequate irrigation to eliminate bacteria, dissolve organic tissue, and remove debris from areas that instruments cannot reach. Due to the complex anatomy of the root canal system, studies have shown that nearly 35% of the canal walls remain untouched after instrumentation. Therefore, irrigation plays a vital role in ensuring complete disinfection of the canal system. Furthermore, bacteria are capable of penetrating 300-500 micrometers into the dentinal tubules, making it essential for the irrigant to reach as deep as possible within the canal.
Conventionally, sodium hypochlorite is delivered into the canal using a syringe and needle. Although it is considered the gold standard irrigant because of its tissue-dissolving ability and broad-spectrum antimicrobial action, conventional needle irrigation has limitations. The irrigant generally does not travel beyond the tip of the needle, leaving the apical third and other complex areas inadequately cleaned. To overcome these shortcomings, newer irrigation activation methods such as side-vented needles and ultrasonic irrigation have been introduced to improve irrigant flow and penetration throughout the root canal system.
The purpose of this study is to compare three irrigation techniques-Conventional Needle Irrigation (CNI), Side-Vented Needle Irrigation (SVN), and Ultrasonic Irrigation (UI)-to determine which technique provides the deepest penetration of the irrigant into the apical third of the root canal. The hypothesis of the study is that ultrasonic irrigation, being an active irrigation technique, will result in significantly greater irrigant penetration than conventional needle irrigation and side-vented needle irrigation.
According to the synopsis, this study is designed as a randomized controlled trial and will be conducted in the Department of Operative Dentistry over a period of one year after approval. A total sample size of 105 teeth will be included, with 35 samples allocated to each of the three study groups. The study will include extracted single-rooted mandibular first and second premolars with straight canals and closed apices, while teeth with open apices, curved canals, or calcified canals will be excluded.
Initially, all selected teeth will be examined radiographically to exclude unsuitable samples. Standard access cavity preparation will then be carried out, followed by determination of the working length. The canals will be instrumented using the ProTaper rotary system up to file F3, while sodium hypochlorite will be used as the irrigating solution during instrumentation. After completion of canal preparation, the samples will be randomly assigned to one of the three irrigation groups: Conventional Needle Irrigation, Side-Vented Needle Irrigation, or Ultrasonic Irrigation.
To assess irrigant penetration, a radiopaque iohexol dye will be mixed with sodium hypochlorite. After irrigation using the assigned technique, digital radiographs will be obtained. The distance from the apical foramen to the deepest point reached by the radiopaque irrigant will be measured for each sample. This measurement will represent the depth of irrigant penetration achieved by each irrigation technique.
The collected data will be entered into Microsoft Excel and analyzed using SPSS version 23. Descriptive statistics, including the mean and standard deviation, will be calculated to compare the irrigant penetration among the three groups. Based on the study hypothesis, ultrasonic irrigation is expected to demonstrate the greatest penetration into the apical third of the root canal, suggesting that it may provide superior canal disinfection compared with conventional and side-vented needle irrigation. This expectation reflects the hypothesis stated in the synopsis rather than study results, as the research has not yet been conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Needle Irrigation | Active comparator | Procedure: Conventional NeedleParticipants in this group will receive root canal irrigation using a conventional 27-gauge syringe needle. The irrigant, consisting of a radiopaque iohexol dye mixed with 5.25% sodium hypochlorite, will be delivered into the prepared root canal using the conventional needle irrigation technique. Irrigant penetration into the apical third will be assessed using digital radiographs. |
| Side Vented Needle Irrigation | Active comparator | Procedure: Side Vented NeedleParticipants in this group will receive root canal irrigation using a side-vented irrigation needle. The radiopaque irrigant solution, prepared by mixing iohexol dye with 5.25% sodium hypochlorite, will be delivered into the canal using the side-vented needle technique. Irrigant penetration into the apical third will be measured on digital radiographs. |
| Ultrasonic Irrigation | Experimental | Procedure: Ultrasonic IrrigationParticipants in this group will receive ultrasonic irrigation following completion of canal preparation. A radiopaque irrigant solution consisting of iohexol dye mixed with 5.25% sodium hypochlorite will be ultrasonically activated within the root canal. Digital radiographs will be used to measure the depth of irrigant penetration into the apical third and compare it with the other irrigation techniques |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Straight Canals
- Single Rooted 1st and 2nd mandibular premolars with closed apices
Key exclusion criteria (2 listed)
- Mandibular premolars with open apices
- Mandibular premolars with curved or calcified canals
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 |
|---|---|---|
| Conventional NeedleConventional syringe irrigation will be performed using a 27-gauge needle to deliver the radiopaque sodium hypochlorite solution into the prepared root canal. No additional activation technique will be used during irrigation | Procedure or surgery | Conventional Needle Irrigation |
| Side Vented NeedleIrrigation will be carried out using a side-vented needle to introduce the radiopaque sodium hypochlorite solution into the prepared canal. The side-vented design is intended to improve irrigant distribution within the canal while minimizing direct apical flow | Procedure or surgery | Side Vented Needle Irrigation |
| Ultrasonic IrrigationFollowing canal preparation, the radiopaque sodium hypochlorite solution will be activated using an ultrasonic device to enhance irrigant movement throughout the root canal system before radiographic evaluation of penetration depth. | Procedure or surgery | Ultrasonic Irrigation |
Primary outcome
Depth of irrigant penetration into the apical third of the root canal (measured in millimeters).
Time frame: 5 months
The primary outcome is the depth of penetration of a radiopaque irrigant solution into the apical third of the root canal following irrigation with Conventional Needle Irrigation (CNI), Side-Vented Needle Irrigation (SVN), or Ultrasonic Irrigation (UI). Penetration depth will be measured on digital radiographs as the distance from the apical foramen to the deepest point reached by the irrigant.
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 28 Jul 2026.
- Individual participant dataSharing planned: No
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.
Haroon H Panezai, BDS principal investigator
School Of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Needle, Side Vented Needle and Ultrasonic Irrigation in people with Three Canal Irrigation Methods and Their Comparison and Penetration of Irrigant in the Root Canal, run by Pakistan Institute of Medical Sciences.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Haroon H Panezai, BDS (+923128708722, haroonhpanezai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depth of irrigant penetration into the apical third of the root canal (measured in millimeters). (time frame: 5 months). 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 28 Jul 2026.