Endodontic DiseaseNCT05959629
Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) Laser in Root Canal Disinfection
A study testing Waterlase Express™, BIOLASE® and Sodium Hypochlorite in people with Endodontic Disease and Root Canal Infection, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to develop a protocol for biofilms disinfection with a FDA cleared, clinically approved and commercially available Er,Cr:YSGG laser treatments. This protocol will be testing local single topical application of Lasers within the canal system in patients going through routine endodontic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease, Root Canal Infection
- What is being tested?
- Waterlase Express™, BIOLASE® and Sodium Hypochlorite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2023to 2 May 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female (Gender is not an inclusion or exclusion criteria), aged 18 years old or above.
- In good general health as evidenced by medical history or non-contributory medical history (Patient can be seen for regular dental appointment in Penn Dental Medicine; American Society of Anesthesiologists (ASA) classes I and II).
- Radiographic presence of periapical radiolucency.
- Negative response to thermal sensitivity testing (difluorochloromethane at -50 °C, Endo-Ice, Coltène/Whaledent Inc., Cuyahoga Falls, Ohio) or electric pulp testing.
Show all 9Show fewer
- Enough tooth structure for adequate isolation with rubber dam.
- No history of previous endodontic treatment on the tooth.
- Teeth with single canal, 1 distal canal of lower molar, 1 palatal canal of upper molar.
Who cannot join
- Patients who report they are pregnant.
- Teeth affected by dental trauma.
- Periodontal changes (pockets 3 mm, mobility I or gingival edema).
- Radiographic presence of resorptive processes.
- Per the investigator's discretion, unable or unlikely to comply with study procedure.
- Presence of any condition which, in the opinion of the investigator, makes participation in the study not in the individual's best interest.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, School of Dental Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Clinical Use of Er,Cr:YSGG Laser: an Anti-biofilm Treatment
The purpose of this study is to develop a protocol for biofilms disinfection with a FDA cleared, clinically approved and commercially available Er,Cr:YSGG laser treatments. This protocol will be testing local single topical application of Lasers within the canal system in patients going through routine endodontic treatment, evaluate its potential as anti-biofilm treatment and compare it to other currently used antibacterial protocols.
Read the detailed description
After being informed about the study and its potential risk, for all patients giving written informed consent we will screen potential participants by inclusion and exclusion criteria; clinical assessment, obtain radiographs, medical history/medications and documents to determine eligibility for study entry. Participants who meet the eligibility requirements will be randomized in a 1:1 ratio to Group 1: Standard of care irrigation protocol "Sodium Hypochlorite (NaOCl)", Group 2: Er,Cr:YSGG laser + standard of care irrigation protocol (NaOCl).
- Conditions
- Endodontic Disease, Root Canal Infection
- Being tested
- Waterlase Express™, BIOLASE®, Sodium Hypochlorite
- Keywords
- Root Canal Irrigants, lasers
- 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.
Waterlase Express™, BIOLASE®Device
Also called Er,Cr:YSGG laser, Waterlase Express™
Er,Cr:YSGG laser 2780nm (Waterlase Express™, BIOLASE®) with 300μm tip (EdgePro #3) will be placed into the mid-root of the canal. The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).
Sodium HypochloriteOther
Also called NaOCl
Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.
| Study group | Role | What they receive |
|---|---|---|
| Waterlase Express™, BIOLASE® | Experimental | Root canals will be instrumented up to size 30/0.04 taper using Er,Cr:YSGG laser (Waterlase Express™, BIOLASE®), followed by standard of care (NaOCl). Receives: Device: Waterlase Express™, BIOLASE® |
| Sodium Hypochlorite | Active comparator | Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Receives: Other: Sodium Hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol).
By measuring change in bacteria colony forming units (CFU) before and after treatment for the experimental group (laser) and the standard of care (NaOCl) group, then comparing the two groups.
Measured: All samples will be taken during the first root canal treatment visit. Sample1 before cleaning or shaping the root canal.
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol).
By measuring change in bacteria colony forming units (CFU) before and after treatment for the experimental group (laser) and the standard of care (NaOCl) group, then comparing the two groups.
Measured: All samples will be taken during the first root canal treatment visit. Sample2 after cleaning and shaping of the root canal using laser or NaOCl.
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol).
By measuring change in bacteria colony forming units (CFU) before and after treatment for the experimental group (laser) and the standard of care (NaOCl) group, then completion of final routine irrigation protocol, then comparing the two groups.
Measured: All samples will be taken during the first root canal treatment visit. Sample 3 Upon completion of final routine irrigation protocol.
Secondary outcomes (12)
Mean Change From Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS)
Following a previous published study done at the Department of Endodontics, University of Pennsylvania. Patients will be asked to rate the intensity of preoperative pain on a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain) before receiving root canal treatment. Along with NRS, the Wong-Baker facial grimace scale (images) will also be presented to the patients to help them in scoring the pain.
Patients will be asked to rate the intensity of postoperative pain at 4-hours after the procedure.
Change = (4 hours score - baseline score)
Measured: At the end of the first root canal treatment visit, patients will be given a survey and asked to rate the intensity of preoperative pain and postoperative pain at 4-hours post treatment
Secondary Outcome: Mean Change From Baseline in Pain Scores at 24 Hours After the Procedure on a Numeric Rating Scale (NRS).
Following a previous published study done at the Department of Endodontics, University of Pennsylvania. Patients will be asked to rate the intensity of preoperative pain on a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain) before receiving root canal treatment. Along with NRS, the Wong-Baker facial grimace scale (images) will also be presented to the patients to help them in scoring the pain.
Patients will be asked to rate the intensity of postoperative pain at 24-hours after the procedure.
Change = (24 hours score - baseline score)
Measured: At the end of the first root canal treatment visit, patients will be given a survey and asked to rate the postoperative pain at 24-hours post treatment
Mean Change From Baseline in Pain Scores at 48-hours After the Procedure on a Numeric Rating Scale (NRS)
Following a previous published study done at the Department of Endodontics, University of Pennsylvania. Patients will be asked to rate the intensity of preoperative pain on a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain) before receiving root canal treatment. Along with NRS, the Wong-Baker facial grimace scale (images) will also be presented to the patients to help them in scoring the pain.
Patients will be asked to rate the intensity of postoperative pain at 48-hours after the procedure.
Change = (48 hours score - baseline score)
Measured: At the end of the first root canal treatment visit, patients will be given a survey and asked to rate the postoperative pain at 48-hours post treatment
Periapical Bone Changes From Baseline in Periapical Radiographs at 6 Months Follow Up
Periapical radiographs will be taken at baseline (preoperative) then at 6 months follow up post root canal filling
Radiographically, Following periapical index (PAI) by Órstavik 1986, description of radiographic findings:
- Normal periapical structures.
- Small changes in the bone structure.
- Change in the bone structure with mineral loss.
- Periodontitis with a well-defined radiolucent area.
- Severe periodontitis with exacerbating features.
Success is defined as either complete (radiographic resolution of a periapical lesion - the radiographic sign of inflammatory processes surrounding a root tip) or incomplete healing (scar tissue formation) and failure includes uncertain healing (radiographic reduction of a periapical lesion or same lesion size) or unsatisfactory healing (increase in lesion size) as determined on the radiograph.
Measured: Periapical bone changes measured at baseline and 6 months follow up (± 7 days) post root canal filling.
Periapical Bone Changes From Baseline in Periapical Radiographs at 1 Year Follow Up
Periapical radiographs will be taken at baseline (preoperative) then at 1 year follow up post root canal filling
Radiographically, Following periapical index (PAI) by Órstavik 1986, description of radiographic findings:
- Normal periapical structures.
- Small changes in the bone structure.
- Change in the bone structure with mineral loss.
- Periodontitis with a well-defined radiolucent area.
- Severe periodontitis with exacerbating features.
Success is defined as either complete (radiographic resolution of a periapical lesion - the radiographic sign of inflammatory processes surrounding a root tip) or incomplete healing (scar tissue formation) and failure includes uncertain healing (radiographic reduction of a periapical lesion or same lesion size) or unsatisfactory healing (increase in lesion size) as determined on the radiograph.
Measured: Periapical bone changes measured at baseline and 1 year follow up (± 7 days) post root canal filling.
Periapical Bone Changes From Baseline in Periapical Radiographs at 2 Years Follow Up
Periapical radiographs will be taken at baseline (preoperative) then at 2 years follow up post root canal filling
Radiographically, Following periapical index (PAI) by Órstavik 1986, description of radiographic findings:
- Normal periapical structures.
- Small changes in the bone structure.
- Change in the bone structure with mineral loss.
- Periodontitis with a well-defined radiolucent area.
- Severe periodontitis with exacerbating features.
Success is defined as either complete (radiographic resolution of a periapical lesion - the radiographic sign of inflammatory processes surrounding a root tip) or incomplete healing (scar tissue formation) and failure includes uncertain healing (radiographic reduction of a periapical lesion or same lesion size) or unsatisfactory healing (increase in lesion size) as determined on the radiograph.
Measured: Periapical bone changes measured at baseline and 2 years follow up (± 7 days) post root canal filling.
Presence of Clinical Signs or Symptoms at 6 Months Follow Up
Clinical signs and symptoms: Pain, swelling, percussion sensitivity and sinus tracts measured at 6 months follow up.
Clinically success is defined by the absence of pain, swelling, percussion sensitivity or sinus tracts.
Clinical failure is defined as the persistent presence of any of the signs and symptoms mentioned above.
Measured: Clinical signs and symptoms measured at 6 months (± 7 days) post root canal filling.
Presence of Clinical Signs or Symptoms at 1 Year Follow Up
Clinical signs and symptoms: Pain, swelling, percussion sensitivity and sinus tracts measured at 1 year follow up.
Clinically success is defined by the absence of pain, swelling, percussion sensitivity or sinus tracts.
Clinical failure is defined as the persistent presence of any of the signs and symptoms mentioned above.
Measured: Clinical signs and symptoms measured at 1 year (± 7 days) post root canal filling.
Presence of Clinical Signs or Symptoms at 2 Years Follow Up
Clinical signs and symptoms: Pain, swelling, percussion sensitivity and sinus tracts measured at 2 years follow up.
Clinically success is defined by the absence of pain, swelling, percussion sensitivity or sinus tracts.
Clinical failure is defined as the persistent presence of any of the signs and symptoms mentioned above.
Measured: Clinical signs and symptoms measured at 2 years (± 7 days) post root canal filling.
Tooth Survival at 6 Months Follow Up
Tooth survival is defined as the presence of the tooth inside the mouth.
Success: Tooth is still present in the oral cavity. Failure: Tooth is extracted for any reason.
Measured: Measured at 6 months (± 7 days) post root canal filling.
Tooth Survival at 1 Year Follow Up
Tooth survival is defined as the presence of the tooth inside the mouth.
Success: Tooth is still present in the oral cavity. Failure: Tooth is extracted for any reason.
Measured: Measured at 1 year (± 7 days) post root canal filling.
Tooth Survival at 2 Years Follow Up
Tooth survival is defined as the presence of the tooth inside the mouth.
Success: Tooth is still present in the oral cavity. Failure: Tooth is extracted for any reason.
Measured: Measured at 2 years (± 7 days) post root canal filling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start11 Oct 2023
- Primary completion2 May 2024
- Study completion2 May 2024
Why it stopped: Unable to follow up participants due to geographic location and other reasons.
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.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Participants are assigned to one of two groups in parallel for the duration of the study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bekir Karabucak, DMD, MS., Principal investigator, Chair and Professor of Endodontics. Postdoctoral Endodontics Program, Director.Flavia Teles, DDS,MS,DMSc, Principal investigator, Associate Professor, Department of Basic & Translational Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959629
- Sponsor's protocol ID
- 853701
- Status last verified
- Sep 2025
- First submitted
- 5 Jul 2023
- Last updated
- 9 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Yu YH, Kushnir L, Kohli M, Karabucak B. Comparing the incidence of postoperative pain after root canal filling with warm vertical obturation with resin-based sealer and sealer-based obturation with calcium silicate-based sealer: a prospective clinical trial. Clin Oral Investig. 2021 Aug;25(8):5033-5042. doi: 10.1007/s00784-021-03814-x. Epub 2021 Feb 8.
PubMed 33555456Orstavik 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 3457698KAKEHASHI S, STANLEY HR, FITZGERALD RJ. THE EFFECTS OF SURGICAL EXPOSURES OF DENTAL PULPS IN GERM-FREE AND CONVENTIONAL LABORATORY RATS. Oral Surg Oral Med Oral Pathol. 1965 Sep;20:340-9. doi: 10.1016/0030-4220(65)90166-0. No abstract available.
PubMed 14342926Bergenholtz G. Micro-organisms from necrotic pulp of traumatized teeth. Odontol Revy. 1974;25(4):347-58. No abstract available.
PubMed 4155793Kerekes K, Tronstad L. Long-term results of endodontic treatment performed with a standardized technique. J Endod. 1979 Mar;5(3):83-90. doi: 10.1016/S0099-2399(79)80154-5. No abstract available.
PubMed 296248Sjogren U, Figdor D, Persson S, Sundqvist G. Influence of infection at the time of root filling on the outcome of endodontic treatment of teeth with apical periodontitis. Int Endod J. 1997 Sep;30(5):297-306. doi: 10.1046/j.1365-2591.1997.00092.x.
PubMed 9477818Bystrom A, Sundqvist G. The antibacterial action of sodium hypochlorite and EDTA in 60 cases of endodontic therapy. Int Endod J. 1985 Jan;18(1):35-40. doi: 10.1111/j.1365-2591.1985.tb00416.x. No abstract available.
PubMed 3922900Bystrom A, Sundqvist G. Bacteriologic evaluation of the effect of 0.5 percent sodium hypochlorite in endodontic therapy. Oral Surg Oral Med Oral Pathol. 1983 Mar;55(3):307-12. doi: 10.1016/0030-4220(83)90333-x.
PubMed 6572884Bystrom A, Sundqvist G. Bacteriologic evaluation of the efficacy of mechanical root canal instrumentation in endodontic therapy. Scand J Dent Res. 1981 Aug;89(4):321-8. doi: 10.1111/j.1600-0722.1981.tb01689.x.
PubMed 6947391Nair PN, Henry S, Cano V, Vera J. Microbial status of apical root canal system of human mandibular first molars with primary apical periodontitis after "one-visit" endodontic treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Feb;99(2):231-52. doi: 10.1016/j.tripleo.2004.10.005.
PubMed 15660098Ricucci D, Siqueira JF Jr, Bate AL, Pitt Ford TR. Histologic investigation of root canal-treated teeth with apical periodontitis: a retrospective study from twenty-four patients. J Endod. 2009 Apr;35(4):493-502. doi: 10.1016/j.joen.2008.12.014.
PubMed 19345793Vera J, Siqueira JF Jr, Ricucci D, Loghin S, Fernandez N, Flores B, Cruz AG. One- versus two-visit endodontic treatment of teeth with apical periodontitis: a histobacteriologic study. J Endod. 2012 Aug;38(8):1040-52. doi: 10.1016/j.joen.2012.04.010. Epub 2012 Jun 12.
PubMed 22794203Ricucci D, Siqueira JF Jr. Biofilms and apical periodontitis: study of prevalence and association with clinical and histopathologic findings. J Endod. 2010 Aug;36(8):1277-88. doi: 10.1016/j.joen.2010.04.007. Epub 2010 Jun 14.
PubMed 20647081Zorita-Garcia M, Alonso-Ezpeleta LO, Cobo M, Del Campo R, Rico-Romano C, Mena-Alvarez J, Zubizarreta-Macho A. Photodynamic therapy in endodontic root canal treatment significantly increases bacterial clearance, preventing apical periodontitis. Quintessence Int. 2019;50(10):782-789. doi: 10.3290/j.qi.a43249.
PubMed 31559398Wang X, Cheng X, Liu B, Liu X, Yu Q, He W. Effect of Laser-Activated Irrigations on Smear Layer Removal from the Root Canal Wall. Photomed Laser Surg. 2017 Dec;35(12):688-694. doi: 10.1089/pho.2017.4266. Epub 2017 Apr 5.
PubMed 28394240
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Use of Er,Cr:YSGG Laser: an Anti-biofilm Treatment
- ClinicalTrials.gov ID
- NCT05959629
- Acronym / sponsor ID
- 853701
- Conditions
- Endodontic Disease, Root Canal Infection
- Keywords
- Root Canal Irrigants, lasers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to follow up participants due to geographic location and other reasons.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Posted 9 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a protocol for biofilms disinfection with a FDA cleared, clinically approved and commercially available Er,Cr:YSGG laser treatments. This protocol will be testing local single topical application of Lasers within the canal system in patients going through routine endodontic treatment, evaluate its potential as anti-biofilm treatment and compare it to other currently used antibacterial protocols.
Detailed description
After being informed about the study and its potential risk, for all patients giving written informed consent we will screen potential participants by inclusion and exclusion criteria; clinical assessment, obtain radiographs, medical history/medications and documents to determine eligibility for study entry. Participants who meet the eligibility requirements will be randomized in a 1:1 ratio to Group 1: Standard of care irrigation protocol "Sodium Hypochlorite (NaOCl)", Group 2: Er,Cr:YSGG laser + standard of care irrigation protocol (NaOCl).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Waterlase Express™, BIOLASE® | Experimental | Device: Waterlase Express™, BIOLASE®Root canals will be instrumented up to size 30/0.04 taper using Er,Cr:YSGG laser (Waterlase Express™, BIOLASE®), followed by standard of care (NaOCl). |
| Sodium Hypochlorite | Active comparator | Other: Sodium HypochloriteRoot canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female (Gender is not an inclusion or exclusion criteria), aged 18 years old or above.
- In good general health as evidenced by medical history or non-contributory medical history (Patient can be seen for regular dental appointment in Penn Dental Medicine; American Society of Anesthesiologists (ASA) classes I and II).
- Radiographic presence of periapical radiolucency.
Key exclusion criteria (6 listed)
- Patients who report they are pregnant.
- Teeth affected by dental trauma.
- Periodontal changes (pockets 3 mm, mobility I or gingival edema).
- Radiographic presence of resorptive processes.
- Per the investigator's discretion, unable or unlikely to comply with study procedure.
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 |
|---|---|---|
| Waterlase Express™, BIOLASE®Also: Er,Cr:YSGG laser, Waterlase Express™Er,Cr:YSGG laser 2780nm (Waterlase Express™, BIOLASE®) with 300μm tip (EdgePro #3) will be placed into the mid-root of the canal. The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water). | Device | Waterlase Express™, BIOLASE® |
| Sodium HypochloriteAlso: NaOClRoot canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files. | Other | Sodium Hypochlorite |
Primary outcome
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol).
Time frame: All samples will be taken during the first root canal treatment visit. Sample1 before cleaning or shaping the root canal.
By measuring change in bacteria colony forming units (CFU) before and after treatment for the experimental group (laser) and the standard of care (NaOCl) group, then comparing the two groups.
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol).
Time frame: All samples will be taken during the first root canal treatment visit. Sample2 after cleaning and shaping of the root canal using laser or NaOCl.
By measuring change in bacteria colony forming units (CFU) before and after treatment for the experimental group (laser) and the standard of care (NaOCl) group, then comparing the two groups.
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol).
Time frame: All samples will be taken during the first root canal treatment visit. Sample 3 Upon completion of final routine irrigation protocol.
By measuring change in bacteria colony forming units (CFU) before and after treatment for the experimental group (laser) and the standard of care (NaOCl) group, then completion of final routine irrigation protocol, then comparing the two groups.
12 secondary outcomes
Mean Change From Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS)
Time frame: At the end of the first root canal treatment visit, patients will be given a survey and asked to rate the intensity of preoperative pain and postoperative pain at 4-hours post treatment
Secondary Outcome: Mean Change From Baseline in Pain Scores at 24 Hours After the Procedure on a Numeric Rating Scale (NRS).
Time frame: At the end of the first root canal treatment visit, patients will be given a survey and asked to rate the postoperative pain at 24-hours post treatment
Mean Change From Baseline in Pain Scores at 48-hours After the Procedure on a Numeric Rating Scale (NRS)
Time frame: At the end of the first root canal treatment visit, patients will be given a survey and asked to rate the postoperative pain at 48-hours post treatment
Periapical Bone Changes From Baseline in Periapical Radiographs at 6 Months Follow Up
Time frame: Periapical bone changes measured at baseline and 6 months follow up (± 7 days) post root canal filling.
Periapical Bone Changes From Baseline in Periapical Radiographs at 1 Year Follow Up
Time frame: Periapical bone changes measured at baseline and 1 year follow up (± 7 days) post root canal filling.
Periapical Bone Changes From Baseline in Periapical Radiographs at 2 Years Follow Up
Time frame: Periapical bone changes measured at baseline and 2 years follow up (± 7 days) post root canal filling.
Presence of Clinical Signs or Symptoms at 6 Months Follow Up
Time frame: Clinical signs and symptoms measured at 6 months (± 7 days) post root canal filling.
Presence of Clinical Signs or Symptoms at 1 Year Follow Up
Time frame: Clinical signs and symptoms measured at 1 year (± 7 days) post root canal filling.
Presence of Clinical Signs or Symptoms at 2 Years Follow Up
Time frame: Clinical signs and symptoms measured at 2 years (± 7 days) post root canal filling.
Tooth Survival at 6 Months Follow Up
Time frame: Measured at 6 months (± 7 days) post root canal filling.
Tooth Survival at 1 Year Follow Up
Time frame: Measured at 1 year (± 7 days) post root canal filling.
Tooth Survival at 2 Years Follow Up
Time frame: Measured at 2 years (± 7 days) post root canal filling.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33555456Yu YH, Kushnir L, Kohli M, Karabucak B. Comparing the incidence of postoperative pain after root canal filling with warm vertical obturation with resin-based sealer and sealer-based obturation with calcium silicate-based sealer: a prospective clinical trial. Clin Oral Investig. 2021 Aug;25(8):5033-5042. doi: 10.1007/s00784-021-03814-x. Epub 2021 Feb 8.
- 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 14342926KAKEHASHI S, STANLEY HR, FITZGERALD RJ. THE EFFECTS OF SURGICAL EXPOSURES OF DENTAL PULPS IN GERM-FREE AND CONVENTIONAL LABORATORY RATS. Oral Surg Oral Med Oral Pathol. 1965 Sep;20:340-9. doi: 10.1016/0030-4220(65)90166-0. No abstract available.
- Background: PubMed 4155793Bergenholtz G. Micro-organisms from necrotic pulp of traumatized teeth. Odontol Revy. 1974;25(4):347-58. No abstract available.
- Background: PubMed 296248Kerekes K, Tronstad L. Long-term results of endodontic treatment performed with a standardized technique. J Endod. 1979 Mar;5(3):83-90. doi: 10.1016/S0099-2399(79)80154-5. No abstract available.
- Background: PubMed 9477818Sjogren U, Figdor D, Persson S, Sundqvist G. Influence of infection at the time of root filling on the outcome of endodontic treatment of teeth with apical periodontitis. Int Endod J. 1997 Sep;30(5):297-306. doi: 10.1046/j.1365-2591.1997.00092.x.
- Background: PubMed 3922900Bystrom A, Sundqvist G. The antibacterial action of sodium hypochlorite and EDTA in 60 cases of endodontic therapy. Int Endod J. 1985 Jan;18(1):35-40. doi: 10.1111/j.1365-2591.1985.tb00416.x. No abstract available.
- Background: PubMed 6572884Bystrom A, Sundqvist G. Bacteriologic evaluation of the effect of 0.5 percent sodium hypochlorite in endodontic therapy. Oral Surg Oral Med Oral Pathol. 1983 Mar;55(3):307-12. doi: 10.1016/0030-4220(83)90333-x.
- Background: PubMed 6947391Bystrom A, Sundqvist G. Bacteriologic evaluation of the efficacy of mechanical root canal instrumentation in endodontic therapy. Scand J Dent Res. 1981 Aug;89(4):321-8. doi: 10.1111/j.1600-0722.1981.tb01689.x.
- Background: PubMed 15660098Nair PN, Henry S, Cano V, Vera J. Microbial status of apical root canal system of human mandibular first molars with primary apical periodontitis after "one-visit" endodontic treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Feb;99(2):231-52. doi: 10.1016/j.tripleo.2004.10.005.
- Background: PubMed 19345793Ricucci D, Siqueira JF Jr, Bate AL, Pitt Ford TR. Histologic investigation of root canal-treated teeth with apical periodontitis: a retrospective study from twenty-four patients. J Endod. 2009 Apr;35(4):493-502. doi: 10.1016/j.joen.2008.12.014.
- Background: PubMed 22794203Vera J, Siqueira JF Jr, Ricucci D, Loghin S, Fernandez N, Flores B, Cruz AG. One- versus two-visit endodontic treatment of teeth with apical periodontitis: a histobacteriologic study. J Endod. 2012 Aug;38(8):1040-52. doi: 10.1016/j.joen.2012.04.010. Epub 2012 Jun 12.
- Individual participant dataSharing planned: No
Related trials for Endodontic Disease
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
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.
Bekir Karabucak, DMD, MS. principal investigator
Chair and Professor of Endodontics. Postdoctoral Endodontics Program, Director.
Flavia Teles, DDS,MS,DMSc principal investigator
Associate Professor, Department of Basic & Translational Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Waterlase Express™, BIOLASE® and Sodium Hypochlorite in people with Endodontic Disease and Root Canal Infection, run by University of Pennsylvania 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 9 inclusion and 6 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: stopped early, as of the sponsor's last update on 9 Oct 2025. 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 9 Oct 2025). 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?
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol). (time frame: All samples will be taken during the first root canal treatment visit. Sample1 before cleaning or shaping the root canal.). 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 NCT05959629, which also lists 25 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 9 Oct 2025.