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Unable to follow up participants due to geographic location and other reasons.
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Sodium Hypochlorite | Active Comparator | Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Waterlase Express™, BIOLASE® | Device | 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 The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | All samples will be taken during the first root canal treatment visit. Sample 3 Upon completion of final routine irrigation protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bekir Karabucak, DMD, MS. | Chair and Professor of Endodontics. Postdoctoral Endodontics Program, Director. | Principal Investigator |
| Flavia Teles, DDS,MS,DMSc | Associate Professor, Department of Basic & Translational Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania, School of Dental Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33555456 | Background | 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. | |
| 3457698 |
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Allocated to control: n=28, received allocated control =26. 2 when accessed were partially necrotic.
Allocated to intervention: n=28, received allocated control =26. 2 had technical issues.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). Waterlase Express™, BIOLASE®: 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). |
| FG001 | Sodium Hypochlorite | Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). Waterlase Express™, BIOLASE®: 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Mean CFU | All samples will be taken during the first root canal treatment visit. Sample1 before cleaning or shaping the root canal. |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). Waterlase Express™, BIOLASE®: 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bekir Karabucak | University of Pennsylvania School of Dental Medicine | 215-898-4927 | bekirk@upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2023 | May 12, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012973 | Sodium Hypochlorite |
| ID | Term |
|---|---|
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
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Participants are assigned to one of two groups in parallel for the duration of the study
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|
|
| Sodium Hypochlorite | Other | Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files. |
|
|
| 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) | 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) | 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:
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. | 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:
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. | 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:
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. | 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. | 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. | 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. | 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 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 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 at 2 years (± 7 days) post root canal filling. |
| 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. |
| 14342926 | Background | KAKEHASHI 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. |
| 4155793 | Background | Bergenholtz G. Micro-organisms from necrotic pulp of traumatized teeth. Odontol Revy. 1974;25(4):347-58. No abstract available. |
| 296248 | Background | Kerekes 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. |
| 9477818 | Background | Sjogren 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. |
| 3922900 | Background | Bystrom 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. |
| 6572884 | Background | Bystrom 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. |
| 6947391 | Background | Bystrom 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. |
| 15660098 | Background | Nair 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. |
| 19345793 | Background | Ricucci 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. |
| 22794203 | Background | Vera 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. |
| 20647081 | Background | Ricucci 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. |
| 31559398 | Background | Zorita-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. |
| 28394240 | Background | Wang 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. |
| 31809911 | Background | Bordea IR, Hanna R, Chiniforush N, Gradinaru E, Campian RS, Sirbu A, Amaroli A, Benedicenti S. Evaluation of the outcome of various laser therapy applications in root canal disinfection: A systematic review. Photodiagnosis Photodyn Ther. 2020 Mar;29:101611. doi: 10.1016/j.pdpdt.2019.101611. Epub 2019 Dec 3. |
| 22243483 | Background | Meire MA, Coenye T, Nelis HJ, De Moor RJ. Evaluation of Nd:YAG and Er:YAG irradiation, antibacterial photodynamic therapy and sodium hypochlorite treatment on Enterococcus faecalis biofilms. Int Endod J. 2012 May;45(5):482-91. doi: 10.1111/j.1365-2591.2011.02000.x. Epub 2012 Jan 14. |
| 35406207 | Background | Josic U, Mazzitelli C, Maravic T, Fidler A, Breschi L, Mazzoni A. Biofilm in Endodontics: In Vitro Cultivation Possibilities, Sonic-, Ultrasonic- and Laser-Assisted Removal Techniques and Evaluation of the Cleaning Efficacy. Polymers (Basel). 2022 Mar 25;14(7):1334. doi: 10.3390/polym14071334. |
| 23211068 | Background | Seet AN, Zilm PS, Gully NJ, Cathro PR. Qualitative comparison of sonic or laser energisation of 4% sodium hypochlorite on an Enterococcus faecalis biofilm grown in vitro. Aust Endod J. 2012 Dec;38(3):100-6. doi: 10.1111/j.1747-4477.2012.00366.x. Epub 2012 Jul 16. |
| 32913155 | Background | Suer K, Ozkan L, Guvenir M. Antimicrobial effects of sodium hypochlorite and Er,Cr:YSGG laser against Enterococcus faecalis biofilm. Niger J Clin Pract. 2020 Sep;23(9):1188-1193. doi: 10.4103/njcp.njcp_632_18. |
| 24328607 | Background | Martins MR, Carvalho MF, Pina-Vaz I, Capelas JA, Martins MA, Gutknecht N. Outcome of Er,Cr:YSGG laser-assisted treatment of teeth with apical periodontitis: a blind randomized clinical trial. Photomed Laser Surg. 2014 Jan;32(1):3-9. doi: 10.1089/pho.2013.3573. Epub 2013 Dec 13. |
| 9855830 | Background | Dalton BC, Orstavik D, Phillips C, Pettiette M, Trope M. Bacterial reduction with nickel-titanium rotary instrumentation. J Endod. 1998 Nov;24(11):763-7. doi: 10.1016/S0099-2399(98)80170-2. |
| 11471648 | Background | Shuping GB, Orstavik D, Sigurdsson A, Trope M. Reduction of intracanal bacteria using nickel-titanium rotary instrumentation and various medications. J Endod. 2000 Dec;26(12):751-5. doi: 10.1097/00004770-200012000-00022. |
| 15851929 | Background | McGurkin-Smith R, Trope M, Caplan D, Sigurdsson A. Reduction of intracanal bacteria using GT rotary instrumentation, 5.25% NaOCl, EDTA, and Ca(OH)2. J Endod. 2005 May;31(5):359-63. doi: 10.1097/01.don.0000145035.85272.7c. |
| 17963947 | Background | Wang CS, Arnold RR, Trope M, Teixeira FB. Clinical efficiency of 2% chlorhexidine gel in reducing intracanal bacteria. J Endod. 2007 Nov;33(11):1283-9. doi: 10.1016/j.joen.2007.07.010. |
| BG001 | Sodium Hypochlorite | Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | participants included in the study | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Sodium Hypochlorite | Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Mean CFU | 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. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Mean CFU | All samples will be taken during the first root canal treatment visit. Sample 3 Upon completion of final routine irrigation protocol. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | 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 | 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) | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
| Secondary | 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:
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. | The study was terminated. Data were not collected for this measure at any time point. Unable to follow up participants due to their geographic location and other reasons. | Posted | Periapical bone changes measured at baseline and 6 months follow up (± 7 days) post root canal filling. |
|
|
| Secondary | 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:
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. | The study was terminated. Data were not collected for this measure at any time point. Unable to follow up participants due to their geographic location and other reasons. | Posted | Periapical bone changes measured at baseline and 1 year follow up (± 7 days) post root canal filling. |
|
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| Secondary | 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:
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. | The study was terminated. Data were not collected for this measure at any time point. Unable to follow up participants due to their geographic location and other reasons. | Posted | Periapical bone changes measured at baseline and 2 years follow up (± 7 days) post root canal filling. |
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| Secondary | 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. | The study was terminated. Data were not collected for this measure at any time point. Unable to follow up participants due to their geographic location and other reasons. | Posted | Clinical signs and symptoms measured at 6 months (± 7 days) post root canal filling. |
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| Secondary | 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. | The study was terminated. Data were not collected for this measure at any time point. Unable to follow up participants due to their geographic location and other reasons. | Posted | Clinical signs and symptoms measured at 1 year (± 7 days) post root canal filling. |
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| Secondary | 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. | The study was terminated. Data were not collected for this measure at any time point. Unable to follow up participants due to their geographic location and other reasons. | Posted | Clinical signs and symptoms measured at 2 years (± 7 days) post root canal filling. |
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| Secondary | 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. | The study was terminated. Data were not collected for this measure at any time point. Unable to follow up participants due to their geographic location and other reasons. | Posted | Measured at 6 months (± 7 days) post root canal filling. |
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| Secondary | 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. | The study was terminated. Data were not collected for this measure at any time point. Unable to follow up participants due to their geographic location and other reasons. | Posted | Measured at 1 year (± 7 days) post root canal filling. |
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| Secondary | 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. | The study was terminated. Data were not collected for this measure at any time point. Unable to follow up participants due to their geographic location and other reasons. | Posted | Measured at 2 years (± 7 days) post root canal filling. |
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| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Sodium Hypochlorite | Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files. | 0 | 26 | 0 | 26 | 0 | 26 |
Not provided
Not provided
Not provided
| D017601 |
| Oxygen Compounds |
| D017670 | Sodium Compounds |