Pulp Disease, DentalNCT07852312
Clinical Outcomes of Root Canal Treatment Using Modern Irrigation Protocols
A study testing GentleWave®, EdgePRO™ and Fotona LightWalker® in people with Pulp Disease, Dental, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Post-operative pain remains a frequent complication after root canal treatments. This clinical trial evaluates the post-operative outcome following endodontic treatments using four irrigation approaches: conventional needle irrigation, GentleWave®, EdgePRO™, and Fotona LightWalker®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulp Disease, Dental
- What is being tested?
- GentleWave®, EdgePRO™ and Fotona LightWalker®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Oct 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults older than 18 years of age who need root canal treatment.
Who cannot join
- The intake of analgesics within the previous 8h, substance abuse, additional pulpal pathology on the same side, systemic conditions classified as ASA III or higher.
- Adults unable to consent, minors less than 18 years of age, pregnant women, and prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qian Xie, BDS, MS, PhD contact
United States1 site
University of Illinois Chicago, College of Dentistry, Department of Endodontics
Chicago, Illinois, 60612
Anh M Bui, DMD, 847-749-6589, anhb826@gmail.com
Qian Xie, BDS, MS, PhD, xieqian@uic.edu
About this study
Post-operative pain remains a frequent complication after root canal treatments. This clinical trial evaluates the post-operative outcome following endodontic treatments using four irrigation approaches: conventional needle irrigation, GentleWave®, EdgePRO™, and Fotona LightWalker®. The study will assess patients' post-operative pain and other symptoms following treatment, as well as healing of the tissues around the treated tooth over time.
Read the detailed description
Conventional needle irrigation is the traditional method that uses a syringe and needle to deliver irrigation solutions into the root canal system to flush out tissue and debris in endodontic therapy. GentleWave®, EdgePRO™, and Fotona LightWalker® are advanced endodontic irrigation systems approved by the Federal Drug Administration as medical devices to prepare, clean, and irrigate root canal anatomy during endodontic therapy. The study compares the post-operative outcome between 4 groups: conventional needle irrigation, irrigation with GentleWave®, irrigation with EdgePRO™, and irrigation with Fotona LightWalker® in root canal treatments. Participants will be asked to report the level of post-operative pain by telephone at approximately 6, 24, 48, and 72 hours after treatment. Each pain assessment will take less than one minute. Participants will also be asked to return to the clinic for follow-up examinations at approximately 6 and 12 months after treatment. Each follow-up visit will take approximately 30 minutes.
- Conditions
- Pulp Disease, Dental
- Being tested
- GentleWave®, EdgePRO™, Fotona LightWalker®, Conventional Needle Irrigation
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentleWave®Device
An advanced endodontic irrigation system that utilizes a vortex of fluids and acoustic energy that cleans the deepest, most complex portions of the root canal system.
Regulatory approval status: FDA cleared
Post-operative pain information will be collected via phone interview.
Complications and adverse effects are the same as with other systems of similar design and traditional root canal therapy, and may include sensitivity, inflammation, and pain.
EdgePRO™Device
An advanced endodontic irrigation system that delivers Laser Light Sound Energy at a specific wavelength and frequency to the irrigants in the canal to form Cavitation Waves throughout the root canal system. This allows optimal cleaning, debridement, and disinfection of the root canal system.
Regulatory approval status: FDA cleared
Post-operative pain information will be collected via phone interview.
Complications and adverse effects are the same as with other systems of similar design and traditional root canal therapy, and may include sensitivity, inflammation, and pain.
Fotona LightWalker®Device
An advanced endodontic irrigation system that combines Er:YAG and Nd:YAG wavelengths to optimize pulse control, intuitive interface, and minimally invasive approach to enhance patient outcomes, improve efficiency, and expand clinical capabilities.
Regulatory approval status: FDA cleared
Post-operative pain information will be collected via phone interview.
Complications and adverse effects are the same as with other systems of similar design and traditional root canal therapy, and may include sensitivity, inflammation, and pain.
Conventional Needle IrrigationDevice
Conventional needle irrigation is the traditional method that uses a syringe and needle to deliver irrigation solutions into the root canal system to flush out tissue and debris in endodontic therapy.
Post-operative pain information will be collected via phone interview.
Complications and adverse effects are the same as with other systems of similar design and traditional root canal therapy, and may include sensitivity, inflammation, and pain.
| Study group | Role | What they receive |
|---|---|---|
| Conventional needle irrigation | Sham comparator | Conventional needle irrigation is the traditional method that uses a syringe and needle to deliver irrigation solutions into the root canal system to flush out tissue and debris in endodontic therapy. Receives: Device: Conventional Needle Irrigation |
| Irrigation with GentleWave® | Active comparator | An advanced endodontic irrigation system that utilizes a vortex of fluids and acoustic energy that cleans the deepest, most complex portions of the root canal system. Receives: Device: GentleWave® |
| Irrigation with EdgePRO™ | Active comparator | An advanced endodontic irrigation system that delivers Laser Light Sound Energy at a specific wavelength and frequency to the irrigants in the canal to form Cavitation Waves throughout the root canal system. This allows optimal cleaning, debridement, and disinfection of the root canal system. Receives: Device: EdgePRO™ |
| Irrigation with Fotona LightWalker® | Active comparator | An advanced endodontic irrigation system that combines Er:YAG and Nd:YAG wavelengths to optimize pulse control, intuitive interface, and minimally invasive approach to enhance patient outcomes, improve efficiency, and expand clinical capabilities. Receives: Device: Fotona LightWalker® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain intensity as assessed by the Numeric Rating Scale (NRS, 0-10)
Pain intensity self-reported on an 11-point Numeric Rating Scale where 0 = no pain and 10 = worst possible pain. The metric is the mean NRS score per group, reported separately at each time point. Higher scores indicate worse pain.
Measured: 6, 24, 48, and 72 hours post-treatment
Number of teeth with radiographic periapical healing as assessed by the Periapical Index (PAI)
Periapical status scored on the 5-point PAI (1 = normal periapical structures; 2 = small bone-structure changes; 3 = bone-structure changes with mineral loss; 4 = well-defined apical radiolucency; 5 = severe periodontitis with exacerbating features) on periapical radiographs by two calibrated, blinded, independent assessors, with a third assessor arbitrating disagreements. For multirooted teeth the highest root score is recorded. Based on the change in PAI between baseline and follow-up, each tooth is classified into one of three categories:
- Healing (complete healing): final PAI ≤ 2 with no clinical signs or symptoms (complete radiographic resolution).
- Incomplete healing: final PAI reduced compared with baseline but still > 2, with no clinical signs or symptoms (lesion reduced in size but not fully resolved).
- Unhealed: PAI unchanged or increased, and/or presence of clinical signs/symptoms (pain, swelling, sinus tract).
Reported as the proportion (number/total) of teeth.
Measured: 6- and 12-months post-treatment
Number of teeth meeting clinical success criteria (absence of pain, swelling, sinus tract, and normal function)
Clinical success defined as a tooth with no spontaneous or provoked pain, no tenderness to percussion/palpation, no swelling, no sinus tract, and normal function. Reported as the proportion (number/total) of teeth meeting all criteria per group.
Measured: 6 month and 12 month
Secondary outcomes (1)
Analgesic consumption
Binary: present/absent
Measured: At 6, 24, 48, and 72 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulp Disease, DentalStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qian Xie, BDS, MS, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852312
- Sponsor's protocol ID
- 2026-0972
- Status last verified
- Aug 2026
- First submitted
- 10 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Information will be kept confidential at all times. No identifiable data will be collected.
Publications
Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.
PubMed 3457698Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
PubMed 22588748
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Root Canal Treatment Using Modern Irrigation Protocols
- ClinicalTrials.gov ID
- NCT07852312
- Acronym / sponsor ID
- 2026-0972
- Conditions
- Pulp Disease, Dental
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 1 Oct 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.
Post-operative pain remains a frequent complication after root canal treatments. This clinical trial evaluates the post-operative outcome following endodontic treatments using four irrigation approaches: conventional needle irrigation, GentleWave®, EdgePRO™, and Fotona LightWalker®. The study will assess patients' post-operative pain and other symptoms following treatment, as well as healing of the tissues around the treated tooth over time.
Detailed description
Conventional needle irrigation is the traditional method that uses a syringe and needle to deliver irrigation solutions into the root canal system to flush out tissue and debris in endodontic therapy. GentleWave®, EdgePRO™, and Fotona LightWalker® are advanced endodontic irrigation systems approved by the Federal Drug Administration as medical devices to prepare, clean, and irrigate root canal anatomy during endodontic therapy. The study compares the post-operative outcome between 4 groups: conventional needle irrigation, irrigation with GentleWave®, irrigation with EdgePRO™, and irrigation with Fotona LightWalker® in root canal treatments. Participants will be asked to report the level of post-operative pain by telephone at approximately 6, 24, 48, and 72 hours after treatment. Each pain assessment will take less than one minute. Participants will also be asked to return to the clinic for follow-up examinations at approximately 6 and 12 months after treatment. Each follow-up visit will take approximately 30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conventional needle irrigation | Sham comparator | Device: Conventional Needle IrrigationConventional needle irrigation is the traditional method that uses a syringe and needle to deliver irrigation solutions into the root canal system to flush out tissue and debris in endodontic therapy. |
| Irrigation with GentleWave® | Active comparator | Device: GentleWave®An advanced endodontic irrigation system that utilizes a vortex of fluids and acoustic energy that cleans the deepest, most complex portions of the root canal system. |
| Irrigation with EdgePRO™ | Active comparator | Device: EdgePRO™An advanced endodontic irrigation system that delivers Laser Light Sound Energy at a specific wavelength and frequency to the irrigants in the canal to form Cavitation Waves throughout the root canal system. This allows optimal cleaning, debridement, and disinfection of the root canal system. |
| Irrigation with Fotona LightWalker® | Active comparator | Device: Fotona LightWalker®An advanced endodontic irrigation system that combines Er:YAG and Nd:YAG wavelengths to optimize pulse control, intuitive interface, and minimally invasive approach to enhance patient outcomes, improve efficiency, and expand clinical capabilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults older than 18 years of age who need root canal treatment.
Key exclusion criteria (2 listed)
- The intake of analgesics within the previous 8h, substance abuse, additional pulpal pathology on the same side, systemic conditions classified as ASA III or higher.
- Adults unable to consent, minors less than 18 years of age, pregnant women, and prisoners
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 |
|---|---|---|
| GentleWave®An advanced endodontic irrigation system that utilizes a vortex of fluids and acoustic energy that cleans the deepest, most complex portions of the root canal system. Regulatory approval status: FDA cleared Post-operative pain information will be collected via phone interview. Complications and adverse effects are the same as with other systems of similar design and traditional root canal therapy, and may include sensitivity, inflammation, and pain. | Device | Irrigation with GentleWave® |
| EdgePRO™An advanced endodontic irrigation system that delivers Laser Light Sound Energy at a specific wavelength and frequency to the irrigants in the canal to form Cavitation Waves throughout the root canal system. This allows optimal cleaning, debridement, and disinfection of the root canal system. Regulatory approval status: FDA cleared Post-operative pain information will be collected via phone interview. Complications and adverse effects are the same as with other systems of similar design and traditional root canal therapy, and may include sensitivity, inflammation, and pain. | Device | Irrigation with EdgePRO™ |
| Fotona LightWalker®An advanced endodontic irrigation system that combines Er:YAG and Nd:YAG wavelengths to optimize pulse control, intuitive interface, and minimally invasive approach to enhance patient outcomes, improve efficiency, and expand clinical capabilities. Regulatory approval status: FDA cleared Post-operative pain information will be collected via phone interview. Complications and adverse effects are the same as with other systems of similar design and traditional root canal therapy, and may include sensitivity, inflammation, and pain. | Device | Irrigation with Fotona LightWalker® |
| Conventional Needle IrrigationConventional needle irrigation is the traditional method that uses a syringe and needle to deliver irrigation solutions into the root canal system to flush out tissue and debris in endodontic therapy. Post-operative pain information will be collected via phone interview. Complications and adverse effects are the same as with other systems of similar design and traditional root canal therapy, and may include sensitivity, inflammation, and pain. | Device | Conventional needle irrigation |
Primary outcome
Post-operative pain intensity as assessed by the Numeric Rating Scale (NRS, 0-10)
Time frame: 6, 24, 48, and 72 hours post-treatment
Pain intensity self-reported on an 11-point Numeric Rating Scale where 0 = no pain and 10 = worst possible pain. The metric is the mean NRS score per group, reported separately at each time point. Higher scores indicate worse pain.
Number of teeth with radiographic periapical healing as assessed by the Periapical Index (PAI)
Time frame: 6- and 12-months post-treatment
Periapical status scored on the 5-point PAI (1 = normal periapical structures; 2 = small bone-structure changes; 3 = bone-structure changes with mineral loss; 4 = well-defined apical radiolucency; 5 = severe periodontitis with exacerbating features) on periapical radiographs by two calibrated, blinded, independent assessors, with a third assessor arbitrating disagreements. For multirooted teeth the highest root score is recorded. Based on the change in PAI between baseline and follow-up, each tooth is classified into one of three categories: 1. Healing (complete healing): final PAI ≤ 2 with no clinical signs or symptoms (complete radiographic resolution). 2. Incomplete healing: final PAI reduced compared with baseline but still > 2, with no clinical signs or symptoms (lesion reduced in size but not fully resolved). 3. Unhealed: PAI unchanged or increased, and/or presence of clinical signs/symptoms (pain, swelling, sinus tract). Reported as the proportion (number/total) of teeth.
Number of teeth meeting clinical success criteria (absence of pain, swelling, sinus tract, and normal function)
Time frame: 6 month and 12 month
Clinical success defined as a tooth with no spontaneous or provoked pain, no tenderness to percussion/palpation, no swelling, no sinus tract, and normal function. Reported as the proportion (number/total) of teeth meeting all criteria per group.
1 secondary outcome
Analgesic consumption
Time frame: At 6, 24, 48, and 72 hours post-treatment
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 1 Oct 2026.
- Background: PubMed 3457698Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.
- Background: PubMed 22588748Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
- GentleWave®Link provided by the sponsor.
- EdgePRO™Link provided by the sponsor.
- Individual participant dataSharing planned: No. Information will be kept confidential at all times. No identifiable data will be collected.
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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.
Qian Xie, BDS, MS, PhD contact
Qian Xie, BDS, MS, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GentleWave®, EdgePRO™ and Fotona LightWalker® in people with Pulp Disease, Dental, run by University of Illinois Chicago at 1 site in United States.
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 1 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 1 Oct 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 United States. 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. Some participants in this study may receive a placebo. 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 Anh M Bui, DMD (847-749-6589, abui20@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain intensity as assessed by the Numeric Rating Scale (NRS, 0-10) (time frame: 6, 24, 48, and 72 hours post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07852312, which also lists 2 linked publications.
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 1 Oct 2026.