Endodontic DiseaseNCT05555043
Comparison of Clinical Outcomes Between GentleWave® and Biolase®
A study testing Irrisafe ip, GentleWave System and Waterlase iPlus in people with Endodontic Disease and Periapical Diseases, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Introduction: In the US, 15 million root canal treatments (RCTs) are carried out annually. Success rates decrease with conventional chemo-mechanical root canal preparation techniques used on teeth with periapical radiolucencies associated with bacterial presence. Read more about this study
- Who is it for?
- Ages 14 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease, Periapical Diseases, Periapical Periodontitis
- What is being tested?
- Irrisafe ip, GentleWave System and Waterlase iPlus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male and female patients 14 years of age or older (maximum of 99 years of age)
- o Participants 14 years of age or older are expected to have permanent teeth erupted in full permanent dentition with close apices
- The subject tooth is indicated for root canal treatment
- One tooth indicated per participant
- Permanent tooth requiring root canal treatment which are deemed restorable
- Teeth exhibiting pulpal pathosis (irreversible pulpitis, pulpal necrosis, previously initiated root canal treatment) and apical periodontitis (with radiographic demonstration of periapical bone loss)
- Patient-signed informed consent/assent form
- Patients display good compliance o Patient is determined cooperative by provider during initial exam and radiographic acquisition
Who cannot join
- Patients allergic to local or topical anesthetics, heart disease (pacemakers, implantable defibrillators), lung disease, bleeding disorders, immune system deficiency
- Subject tooth is not clinically restorable (prosthetically or periodontally)
- Mobility scores greater than or equal to 2
- Periodontal pocket depths greater than or equal to 6mm
- Cracks with radicular extension, vertical root fracture or horizontal - oblique fracture
- Subject tooth with open or incomplete apices (apical diameter greater than 1mm)
Show all 13Show fewer
- Subject tooth has insufficient tooth structure to create GWS platform
- Subject tooth has external cervical root resorption
- Subject tooth has signs of dens invaginatus
- Subject tooth has signs of a palatogingival groove
- Subject tooth has root(s) which communicate with the maxillary antrum
- Patient has nonodontogenic facial pain
- Patient requires multiple teeth to be endodontically treated
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of North Carolina Adams School of Dentistry
Chapel Hill, North Carolina, 27599
About this study
Official title: Comparison of Clinical Outcomes Between GentleWave® and Biolase®: A Randomized Controlled Trial
Introduction: In the US, 15 million root canal treatments (RCTs) are carried out annually. Success rates decrease with conventional chemo-mechanical root canal preparation techniques used on teeth with periapical radiolucencies associated with bacterial presence. New irrigation modalities, such as the GentleWave® System (GWS) and Waterlase iPlus® (WL), have been developed to overcome limitations and improve RCT success rates.
Hypotheses: (1) GWS and WL provide superior clinical outcomes compared to conventional RCT using passive ultrasonic activation (PUI). (2) GWS and WL are acceptable treatment modalities for clinicians and patients.
Aims: (1) Estimate probability of success of GWS, WL, and conventional RCT with PUI. (2) Evaluate clinician and patient experiences of the different techniques.
Read the detailed description
This is a single-blinded, block randomized control trial study, 120 participants will be recruited with 40 participants randomly allocated to the GWS treatment group, 40 randomly allocated to the WL treatment group, and 40 randomly allocated to the control group (CG) receiving PUI treatment (Fig 1). Participants will be selected consecutively based on our inclusion and exclusion criteria. Participants will be recruited and treated at a single site, the University of North Carolina at Chapel Hill Adams School of Dentistry (UNC-CH ASoD) Endodontic Clinic.
There will be an initial baseline/screening appointment that may or may not develop into the first treatment appointment, followed by a potential second treatment appointment to complete treatment as per current treatment protocols in the Endodontic Clinic. Then participants will be followed for 12 months to evaluate clinical and radiographic healing of periapical lesions. Investigators will also assess clinician and patient opinion of the treatment modality employed in addition to calculation of a cost-time ratio.
Patients will receive endodontic treatment for endodontic infections with potential improvements in procedure outcomes, number of visits, and patient intraprocedural comfort. There are the same risks for any root canal procedure that can include intraprocedural or postoperative sensitivity, inflammation infection, numbness, intraprocedural or postoperative pain, reaction to materials used, sodium hypochlorite extrusion, instrument fracture, or perforation. The investigators will manage these risks through execution of proper instrument usage and adherence to clinical protocols.
The investigators do not anticipate difficulty in recruiting the required number of study participants based on the number of patients seen annually. Each week, approximately fifty patients are seen in the ASoD clinic for endodontic treatment, of which at least 50% meet the inclusion criteria for our study. There are nine trained residents in endodontics who carry out approximately five-six treatments per week. Nevertheless, all subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, and without prejudice. A subject may leave at any time if the subject and/or investigator feel that it is not in the subject's best interest to continue.
Study participants will be consecutively recruited from the Endodontic Clinic at UNC-CH ASoD. Specifically, they will be patients seeking endodontic treatment at ASoD. At the consult/treatment appointment, screened potential participants meeting the inclusion/exclusion criteria will be informed of the study and potential treatment modalities by a member of the research team who is not the treating clinician. Patients will be given adequate time to decide if they would like to participate. Once a participant consents/assents to participation in the study, they will be randomly allocated to either the control group, GentleWave treatment group, or the Waterlase treatment group in a block randomized manner. Once a participant is assigned a treatment, the treatment will take place at the same appointment as the baseline/screening appointment or scheduled for another appointment. Treatment will be completed in one or possibly two appointments. Thereafter, the patient will be scheduled for a 12-month follow up visit to evaluate clinical and radiographic healing of the periapical lesion and tooth. This follow-up appointment, depending on the amount of treatment appointments required to complete treatment, may be the second, third, or fourth appointment.
Patients who agree to participate in the study will be randomized to either the GWS, WL, or control groups. As previously mentioned, each treatment group consists of 40 patients. Eight blocks of fifteen treatments (five of each treatment type) will be used. Once a patient consents/assents to participation in the study, a third party will be contacted who has access to the block randomization and they will inform the research team which treatment the patient is to undergo. This will help with organization of the treatment room with the appropriate equipment. Patient details and treatment allocation will be recorded on a password-protected Excel spreadsheet.
- Being tested
- Irrisafe ip, GentleWave System, Waterlase iPlus
- Medical subject headings
- Dental Pulp Diseases, Periapical Diseases, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrisafe ipDevice
Also called Passive ultrasonic irrigation
This portion of endodontic treatment includes chemical disinfection of the root canal system with these different devices that activate the disinfection solution and distribute it throughout the root canal system with ultrasonic energy.
GentleWave SystemDevice
Also called Sonic cleaning and irrigation
Prepare, clean and irrigate root canals including activation of the disinfection solution and distribution throughout the root canal system.
Waterlase iPlusDevice
Also called Powered Laser Surgical Instrument
Prepare tooth and root canal, including enlargement, to debride, clean and disinfect after endodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participants receive passive ultrasonic irrigation for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth. Receives: Device: Irrisafe ip |
| GentleWave group | Experimental | Participants receive GentleWave System for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth. Receives: Device: GentleWave System |
| Waterlase group | Experimental | Participants receive Waterlase iPlus for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth. Receives: Device: Waterlase iPlus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical Index Score
A combination of the clinical findings and Periapical Index Scores (PAI) score will be used to determine the primary outcome measure as healed, healing, or diseased as per the following descriptions:
(i) Healed: Clinical normalcy other than tenderness to percussion accompanied by PAI scores of 1 or 2 (ii) Healing: Clinical normalcy other than tenderness to percussion accompanied by a reduction in the size of the periradicular lesion denoted by a reduction in the PAI score (iii) Diseased: The presence of clinical signs and symptoms accompanied by a PAI score of 3 or higher or an increase in the PAI score This is a scale of 1-5, where generally a higher number means poorer healing.
Measured: 12 months
Secondary outcomes (6)
Patient Responses to Questionnaires About Treatment Procedure
Questionnaires were sent to patients within 24-48 hours after the initial treatment was completed with various structured questions utilizing the Likert scale. For example, questions consisted of "During my endodontic treatment, I felt comfortable (strongly disagree (1) to strongly agree (5)". Higher score closes to 5 represent higher levels of agreement and lower scores closer to 1 represent higher levels of disagreement with the specific questions. Responses were accepted up to one week after being sent.
Measured: within 1 week after treatment completion
Patients' Subjective Post-Operative Swelling
Questionnaires were sent to patients within 24-48 hours after the initial treatment was completed answering the question "Did you experience swelling or bruising after treatment?" using a yes/no response structure.
Measured: from receipt of questionnaire (24-48 hours) for up to 1 week
Pain Level During Various Time Frames of Treatment
Patients used a visual analog scale (from 0 to 10) to indicate "no pain at all" (i.e., 0) to the "worst pain" (i.e., 10) to assess pre-treatment, inter-treatment, and post-operative pain. Surveys were sent to participants 24-48 hours after treatment to characterize the treatment experience before, during, and within 24 hours afterwards.
Measured: 24-48 hours after treatment
Mean Provider Responses to Questionnaires About Treatment Procedure
An in-house developed questionnaire was sent to providers within 24-48 hours after the initial treatment was completed with various structured questions utilizing the Likert scale. For example, questions consisted of "During my endodontic treatment, I felt comfortable (strongly disagree (1) to strongly agree (5)". Higher scores show a higher level of agreement. Responses were accepted up to one week after being sent.
Measured: within 1 week after treatment completion
Estimated Per-Procedure Treatment Cost
This outcome assesses the cost per treatment procedure (in U.S. dollars) by arm during the 1-hour treatment procedure. It was pre-specified to report a single dollar amount that each participant incurred to reflect the real-world cost for private practice. Cost includes general implementation of each device for a single treatment. This is a fixed estimate per procedure cost and this value was calculated for each arm based on the cost of perishable components that can only be used once per treatment, overall cost of the device, and maintenance fees. These values were obtained by reviewing billing and purchasing records for the devices. No participant-level cost data were collected or analyzed. This outcome does not represent participant-level observations; only one calculated cost value exists for each treatment arm. Therefore, the reported values represent a single calculated cost estimate for each treatment arm, and measures of central tendency and dispersion are not applicable.
Measured: from start to finish of 1-hour treatment procedure
Number of Providers Who Responded
Semi-structured interviews were conducted with providers after completion of all treatments to further assess responses to the initial post-operative survey. Interview questions were open-ended and focused on predefined thematic areas. Responses were analyzed and summarized according to the four most frequently identified themes reported by providers.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start8 Nov 2022
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Model description
- In this block-randomized, single-blinded, randomized control trial, 120 participants will be recruited with 40 participants allocated to the GentleWave System treatment group, 40 participants allocated to the Waterlase treatment group, and 40 participants allocated to a control group receiving commonly used passive ultrasonic irrigation treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Karunanayake, BDS, MS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555043
- Sponsor's protocol ID
- 21-2960
- Status last verified
- Jun 2026
- First submitted
- 19 Sep 2022
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes Between GentleWave® and Biolase®: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05555043
- Acronym / sponsor ID
- 21-2960
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Posted 19 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: In the US, 15 million root canal treatments (RCTs) are carried out annually. Success rates decrease with conventional chemo-mechanical root canal preparation techniques used on teeth with periapical radiolucencies associated with bacterial presence. New irrigation modalities, such as the GentleWave® System (GWS) and Waterlase iPlus® (WL), have been developed to overcome limitations and improve RCT success rates.
Hypotheses: (1) GWS and WL provide superior clinical outcomes compared to conventional RCT using passive ultrasonic activation (PUI). (2) GWS and WL are acceptable treatment modalities for clinicians and patients.
Aims: (1) Estimate probability of success of GWS, WL, and conventional RCT with PUI. (2) Evaluate clinician and patient experiences of the different techniques.
Detailed description
This is a single-blinded, block randomized control trial study, 120 participants will be recruited with 40 participants randomly allocated to the GWS treatment group, 40 randomly allocated to the WL treatment group, and 40 randomly allocated to the control group (CG) receiving PUI treatment (Fig 1). Participants will be selected consecutively based on our inclusion and exclusion criteria. Participants will be recruited and treated at a single site, the University of North Carolina at Chapel Hill Adams School of Dentistry (UNC-CH ASoD) Endodontic Clinic.
There will be an initial baseline/screening appointment that may or may not develop into the first treatment appointment, followed by a potential second treatment appointment to complete treatment as per current treatment protocols in the Endodontic Clinic. Then participants will be followed for 12 months to evaluate clinical and radiographic healing of periapical lesions. Investigators will also assess clinician and patient opinion of the treatment modality employed in addition to calculation of a cost-time ratio.
Patients will receive endodontic treatment for endodontic infections with potential improvements in procedure outcomes, number of visits, and patient intraprocedural comfort. There are the same risks for any root canal procedure that can include intraprocedural or postoperative sensitivity, inflammation infection, numbness, intraprocedural or postoperative pain, reaction to materials used, sodium hypochlorite extrusion, instrument fracture, or perforation. The investigators will manage these risks through execution of proper instrument usage and adherence to clinical protocols.
The investigators do not anticipate difficulty in recruiting the required number of study participants based on the number of patients seen annually. Each week, approximately fifty patients are seen in the ASoD clinic for endodontic treatment, of which at least 50% meet the inclusion criteria for our study. There are nine trained residents in endodontics who carry out approximately five-six treatments per week. Nevertheless, all subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, and without prejudice. A subject may leave at any time if the subject and/or investigator feel that it is not in the subject's best interest to continue.
Study participants will be consecutively recruited from the Endodontic Clinic at UNC-CH ASoD. Specifically, they will be patients seeking endodontic treatment at ASoD. At the consult/treatment appointment, screened potential participants meeting the inclusion/exclusion criteria will be informed of the study and potential treatment modalities by a member of the research team who is not the treating clinician. Patients will be given adequate time to decide if they would like to participate. Once a participant consents/assents to participation in the study, they will be randomly allocated to either the control group, GentleWave treatment group, or the Waterlase treatment group in a block randomized manner. Once a participant is assigned a treatment, the treatment will take place at the same appointment as the baseline/screening appointment or scheduled for another appointment. Treatment will be completed in one or possibly two appointments. Thereafter, the patient will be scheduled for a 12-month follow up visit to evaluate clinical and radiographic healing of the periapical lesion and tooth. This follow-up appointment, depending on the amount of treatment appointments required to complete treatment, may be the second, third, or fourth appointment.
Patients who agree to participate in the study will be randomized to either the GWS, WL, or control groups. As previously mentioned, each treatment group consists of 40 patients. Eight blocks of fifteen treatments (five of each treatment type) will be used. Once a patient consents/assents to participation in the study, a third party will be contacted who has access to the block randomization and they will inform the research team which treatment the patient is to undergo. This will help with organization of the treatment room with the appropriate equipment. Patient details and treatment allocation will be recorded on a password-protected Excel spreadsheet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- In this block-randomized, single-blinded, randomized control trial, 120 participants will be recruited with 40 participants allocated to the GentleWave System treatment group, 40 participants allocated to the Waterlase treatment group, and 40 participants allocated to a control group receiving commonly used passive ultrasonic irrigation treatment.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Irrisafe ipParticipants receive passive ultrasonic irrigation for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth. |
| GentleWave group | Experimental | Device: GentleWave SystemParticipants receive GentleWave System for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth. |
| Waterlase group | Experimental | Device: Waterlase iPlusParticipants receive Waterlase iPlus for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth. |
Who may qualify
- Ages
- 14 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients 14 years of age or older (maximum of 99 years of age)
- o Participants 14 years of age or older are expected to have permanent teeth erupted in full permanent dentition with close apices
- The subject tooth is indicated for root canal treatment
- Patient-signed informed consent/assent form
- Patients display good compliance o Patient is determined cooperative by provider during initial exam and radiographic acquisition
Key exclusion criteria (13 listed)
- Patients allergic to local or topical anesthetics, heart disease (pacemakers, implantable defibrillators), lung disease, bleeding disorders, immune system deficiency
- Subject tooth is not clinically restorable (prosthetically or periodontally)
- Subject tooth with open or incomplete apices (apical diameter greater than 1mm)
- Subject tooth has insufficient tooth structure to create GWS platform
- Subject tooth has external cervical root resorption
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 |
|---|---|---|
| Irrisafe ipAlso: Passive ultrasonic irrigationThis portion of endodontic treatment includes chemical disinfection of the root canal system with these different devices that activate the disinfection solution and distribute it throughout the root canal system with ultrasonic energy. | Device | Control group |
| GentleWave SystemAlso: Sonic cleaning and irrigationPrepare, clean and irrigate root canals including activation of the disinfection solution and distribution throughout the root canal system. | Device | GentleWave group |
| Waterlase iPlusAlso: Powered Laser Surgical InstrumentPrepare tooth and root canal, including enlargement, to debride, clean and disinfect after endodontic treatment. | Device | Waterlase group |
Primary outcome
Periapical Index Score
Time frame: 12 months
A combination of the clinical findings and Periapical Index Scores (PAI) score will be used to determine the primary outcome measure as healed, healing, or diseased as per the following descriptions: (i) Healed: Clinical normalcy other than tenderness to percussion accompanied by PAI scores of 1 or 2 (ii) Healing: Clinical normalcy other than tenderness to percussion accompanied by a reduction in the size of the periradicular lesion denoted by a reduction in the PAI score (iii) Diseased: The presence of clinical signs and symptoms accompanied by a PAI score of 3 or higher or an increase in the PAI score This is a scale of 1-5, where generally a higher number means poorer healing.
6 secondary outcomes
Patient Responses to Questionnaires About Treatment Procedure
Time frame: within 1 week after treatment completion
Patients' Subjective Post-Operative Swelling
Time frame: from receipt of questionnaire (24-48 hours) for up to 1 week
Pain Level During Various Time Frames of Treatment
Time frame: 24-48 hours after treatment
Mean Provider Responses to Questionnaires About Treatment Procedure
Time frame: within 1 week after treatment completion
Estimated Per-Procedure Treatment Cost
Time frame: from start to finish of 1-hour treatment procedure
Number of Providers Who Responded
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Glenn Karunanayake, BDS, MS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrisafe ip, GentleWave System and Waterlase iPlus in people with Endodontic Disease and Periapical Diseases, run by University of North Carolina, Chapel Hill 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 8 inclusion and 13 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 19 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 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. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Periapical Index Score (time frame: 12 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 19 Aug 2026.