Pain, PostoperativeEDRCD-PPNCT07355816
Effect of Different Root Canal Disinfection Procedures on Postoperative Pain
A study testing Conventional Needle Irrigation, Passive Ultrasonic Irrigation and Sonic Irrigation in people with Pain, Postoperative, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
This clinical study evaluated the effects of different root canal disinfection procedures on postoperative pain. Patients requiring root canal treatment received one of several disinfection methods. Postoperative pain was assessed at 6,24, 48, 72 hours and on the 7th day using a standard pain scale. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Conventional Needle Irrigation, Passive Ultrasonic Irrigation and Sonic Irrigation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jun 2023to 11 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy individuals between the ages of 18 and 65,
- Adequate mouth opening,
- Asymptomatic devitaled mandibular premolar with a single root and single canal,
- Negative response to cold and electric pulp tests and no bleeding at the pulp chamber opening,
- Able to provide rubber dam isolation,
- Presence of opposing teeth.
Who cannot join
- Presence of mental or psychiatric disorders,
- Allergic diseases,
- Use of painkillers within 12 hours or antibiotics within 1 week before the procedure,
- Swelling, palpation/percussion pain, or sinus tract before treatment,
- Presence of a periodontal pocket greater than 3 mm in diameter on the involved tooth,
- Presence of a periapical radiolucency greater than 5 mm in diameter associated with the involved tooth,
Show all 15Show fewer
- Initiation of root canal treatment,
- Irreparable material loss, root fracture, or crack,
- Severe mobility,
- Open apex,
- Severe root canal calcification,
- Internal or external resorption,
- Bruxism,
- Complaints of pain elsewhere in the mouth or in a tooth,
- Being pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Dentistry, Cumhuriyet University, Sivas
Sivas, 58000
About this study
Official title: Effect of Different Root Canal Disinfection Procedures on Postoperative Pain: A One-Week Follow-Up Clinical Study
This clinical study evaluated the effects of different root canal disinfection procedures on postoperative pain. Patients requiring root canal treatment received one of several disinfection methods. Postoperative pain was assessed at 6,24, 48, 72 hours and on the 7th day using a standard pain scale. The aim of the study was to identify which method resulted in the least discomfort. Participation involved a single treatment session and short-term follow-up for pain measurement.
- Conditions
- Pain, Postoperative
- Being tested
- Conventional Needle Irrigation, Passive Ultrasonic Irrigation, Sonic Irrigation, KTP Laser Disinfection
- Keywords
- Root Canal Therapy,Disinfection Methods
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Needle IrrigationProcedure or surgery
Root canals will be irrigated using a conventional syringe and needle technique with standard irrigant solutions. This method relies solely on manual delivery without activation devices.
Passive Ultrasonic IrrigationProcedure or surgery
Root canals will be irrigated using passive ultrasonic activation, which uses ultrasonic energy to improve irrigant effectiveness and reduce microbial load beyond manual techniques.
Sonic IrrigationProcedure or surgery
Root canals will be irrigated using a sonic activation device (e.g., EndoActivator) to enhance irrigant penetration and bacterial elimination compared to conventional irrigation.
KTP Laser DisinfectionProcedure or surgery
Root canals will be disinfected using a KTP laser following standard irrigation protocols. Laser application aims to provide enhanced antimicrobial effects not achievable with conventional or activated irrigation methods.
| Study group | Role | What they receive |
|---|---|---|
| conventional needle irrigation | Experimental | Conventional needle irrigation(CNI) Group: A total of 6 mL of 2.5% NaOCl was delivered in three cycles using a 31-gauge irrigation needle positioned 2 mm short of the working length. Each cycle lasted 20 seconds, followed by a 20-second waiting period. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic acid(EDTA) (Imicryl Dental, Konya, Türkiye) was applied for 1 minute, followed by another 1-minute waiting period, and finally 2 mL of distilled water was used as the final rinse. Receives: Procedure: Conventional Needle Irrigation |
| Passive Ultrasonic Irrigation Group | Experimental | Passive ultrasonic irrigation(PUI) Group: Passive ultrasonic activation was performed with an ultrasonic device (Ultra X, Eighteeth, Changzhou, China) using a 20/.02 tip during the waiting periods used in the CNI group. The ultrasonic tip was positioned 2 mm short of the working length and activated vertically with 2-3 mm strokes without contacting the canal walls. Receives: Procedure: Passive Ultrasonic Irrigation |
| Sonic Irrigation Group | Experimental | Sonic irrigation(SI) Group: Sonic activation was performed using a polymer tip (Dentsply Tulsa Dental Specialties) loosely fitted into the canal and placed 2 mm short of the working length during the waiting periods used in the CNI group. The tip was activated by vertical in-and-out motion to induce sonic agitation. Receives: Procedure: Sonic Irrigation |
| KTP Laser Disinfection Group | Experimental | Potassium titanyl phosphate(KTP) Laser Group: In this group, after shaping was completed, the final irrigation procedure was carried out as in the CNI group. Following irrigation, the root canals were dried with sterile paper points at the working length. Then, KTP laser irradiation (SMARLITE D, DEKA laser system, Calenzano FI, Italy) was applied in a pulsed mode at 1.5 W power (Ton: 20 ms, Toff: 50 ms). A 200 µm fiber tip attached to the handpiece was inserted 1 mm short of the working length and moved coronally in a spiral motion for 5 seconds. After each 5-second irradiation, a 20-second interval was allowed, and the process was repeated five times. Laser safety protocols were strictly followed, and protective goggles were used by the operator, assistant, and patient. Receives: Procedure: KTP Laser Disinfection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 100, where 0 indicates no pain and 100 indicates the worst pain imaginable; higher scores indicate greater pain severity
Measured: 6, 12, 24, 48, and 72 hours after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start13 Jun 2023
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İbrahim AKDENİZ, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355816
- Sponsor's protocol ID
- 2022-11/01
- Acronym
- EDRCD-PP
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2025
- Last updated
- 21 Jan 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Root Canal Disinfection Procedures on Postoperative Pain: A One-Week Follow-Up Clinical Study
- ClinicalTrials.gov ID
- NCT07355816
- Acronym / sponsor ID
- EDRCD-PP / 2022-11/01
- Conditions
- Pain, Postoperative
- Keywords
- Root Canal Therapy,Disinfection Methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 21 Jan 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 clinical study evaluated the effects of different root canal disinfection procedures on postoperative pain. Patients requiring root canal treatment received one of several disinfection methods. Postoperative pain was assessed at 6,24, 48, 72 hours and on the 7th day using a standard pain scale. The aim of the study was to identify which method resulted in the least discomfort. Participation involved a single treatment session and short-term follow-up for pain measurement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| conventional needle irrigation | Experimental | Procedure: Conventional Needle IrrigationConventional needle irrigation(CNI) Group: A total of 6 mL of 2.5% NaOCl was delivered in three cycles using a 31-gauge irrigation needle positioned 2 mm short of the working length. Each cycle lasted 20 seconds, followed by a 20-second waiting period. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic acid(EDTA) (Imicryl Dental, Konya, Türkiye) was applied for 1 minute, followed by another 1-minute waiting period, and finally 2 mL of distilled water was used as the final rinse. |
| Passive Ultrasonic Irrigation Group | Experimental | Procedure: Passive Ultrasonic IrrigationPassive ultrasonic irrigation(PUI) Group: Passive ultrasonic activation was performed with an ultrasonic device (Ultra X, Eighteeth, Changzhou, China) using a 20/.02 tip during the waiting periods used in the CNI group. The ultrasonic tip was positioned 2 mm short of the working length and activated vertically with 2-3 mm strokes without contacting the canal walls. |
| Sonic Irrigation Group | Experimental | Procedure: Sonic IrrigationSonic irrigation(SI) Group: Sonic activation was performed using a polymer tip (Dentsply Tulsa Dental Specialties) loosely fitted into the canal and placed 2 mm short of the working length during the waiting periods used in the CNI group. The tip was activated by vertical in-and-out motion to induce sonic agitation. |
| KTP Laser Disinfection Group | Experimental | Procedure: KTP Laser DisinfectionPotassium titanyl phosphate(KTP) Laser Group: In this group, after shaping was completed, the final irrigation procedure was carried out as in the CNI group. Following irrigation, the root canals were dried with sterile paper points at the working length. Then, KTP laser irradiation (SMARLITE D, DEKA laser system, Calenzano FI, Italy) was applied in a pulsed mode at 1.5 W power (Ton: 20 ms, Toff: 50 ms). A 200 µm fiber tip attached to the handpiece was inserted 1 mm short of the working length and moved coronally in a spiral motion for 5 seconds. After each 5-second irradiation, a 20-second interval was allowed, and the process was repeated five times. Laser safety protocols were strictly followed, and protective goggles were used by the operator, assistant, and patient. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Systemically healthy individuals between the ages of 18 and 65,
- Adequate mouth opening,
- Asymptomatic devitaled mandibular premolar with a single root and single canal,
- Negative response to cold and electric pulp tests and no bleeding at the pulp chamber opening,
- Able to provide rubber dam isolation,
Key exclusion criteria (15 listed)
- Presence of mental or psychiatric disorders,
- Allergic diseases,
- Use of painkillers within 12 hours or antibiotics within 1 week before the procedure,
- Swelling, palpation/percussion pain, or sinus tract before treatment,
- Presence of a periodontal pocket greater than 3 mm in diameter on the involved tooth,
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 Needle IrrigationRoot canals will be irrigated using a conventional syringe and needle technique with standard irrigant solutions. This method relies solely on manual delivery without activation devices. | Procedure or surgery | conventional needle irrigation |
| Passive Ultrasonic IrrigationRoot canals will be irrigated using passive ultrasonic activation, which uses ultrasonic energy to improve irrigant effectiveness and reduce microbial load beyond manual techniques. | Procedure or surgery | Passive Ultrasonic Irrigation Group |
| Sonic IrrigationRoot canals will be irrigated using a sonic activation device (e.g., EndoActivator) to enhance irrigant penetration and bacterial elimination compared to conventional irrigation. | Procedure or surgery | Sonic Irrigation Group |
| KTP Laser DisinfectionRoot canals will be disinfected using a KTP laser following standard irrigation protocols. Laser application aims to provide enhanced antimicrobial effects not achievable with conventional or activated irrigation methods. | Procedure or surgery | KTP Laser Disinfection Group |
Primary outcome
Postoperative Pain Intensity
Time frame: 6, 12, 24, 48, and 72 hours after root canal treatment
Postoperative pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 100, where 0 indicates no pain and 100 indicates the worst pain imaginable; higher scores indicate greater pain severity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Needle Irrigation, Passive Ultrasonic Irrigation and Sonic Irrigation in people with Pain, Postoperative, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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 6 inclusion and 15 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: finished, as of the sponsor's last update on 21 Jan 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: 6, 12, 24, 48, and 72 hours after root canal treatment). 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 21 Jan 2026.