Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) Laser in Root Canal Disinfection

Endodontic Disease Clinical Trial

Official title:

A Clinical Use of Er,Cr:YSGG Laser: an Anti-biofilm Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959629
• Other study ID #: 853701
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2023
• Est. completion date: July 2027

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: Dana Mominkhan, B.D.S
• Phone: 773-610-2393
• Email: danakhan[@]upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 treatment, evaluate its potential as anti-biofilm treatment and compare it to other currently used antibacterial protocols.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: July 2027
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Root Canal Infection

Intervention

Device:
• 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).

Other:
• Sodium Hypochlorite
Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.

Locations

Country	Name	City	State
United States	University of Pennsylvania, School of Dental Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (25)

Bergenholtz G. Micro-organisms from necrotic pulp of traumatized teeth. Odontol Revy. 1974;25(4):347-58. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Int Endod J 1998 Mar;31(2):148. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in bacterial count between the experimental group (laser) and the standard of care (NaOCl) group (routinely used irrigation protocol).	By measuring reduction 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.Sample2 after cleaning and shaping of the root canal using laser or NaOCl.Sample3 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)	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	Mean Change from Baseline in Pain Scores at 24-hours After the Procedure on a Numeric Rating Scale (NRS)	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
Secondary	Mean Change from Baseline in Pain Scores at 48-hours After the Procedure on a Numeric Rating Scale (NRS)	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
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: 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.	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: 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.	Periapical bone changes measured at baseline and 1 year follow up (± 7 days) post root canal filling.
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: 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.	Periapical bone changes measured at baseline and 2 years follow up (± 7 days) post root canal filling.
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.	Clinical signs and symptoms measured at 6 months (± 7 days) post root canal filling.
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.	Clinical signs and symptoms measured at 1 year (± 7 days) post root canal filling.
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.	Clinical signs and symptoms measured at 2 years (± 7 days) post root canal filling.
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.	Measured at 6 months (± 7 days) post root canal filling.
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.	Measured at 1 year (± 7 days) post root canal filling.
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.	Measured at 2 years (± 7 days) post root canal filling.