A Clinical Use of Er,Cr:YSGG Laser: an Anti-biofilm Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol).
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Waterlase Express™, BIOLASE® (Device)
结局指标
主要结局
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol).
时间窗: 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.
次要结局
- Tooth Survival at 1 Year Follow Up(Measured at 1 year (± 7 days) post root canal filling.)
- Tooth Survival at 2 Years Follow Up(Measured at 2 years (± 7 days) post root canal filling.)
- Presence of Clinical Signs or Symptoms at 6 Months Follow Up(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 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 measured at 2 years (± 7 days) post root canal filling.)
- Tooth Survival at 6 Months Follow Up(Measured at 6 months (± 7 days) post root canal filling.)
- Mean Change From Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS)(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).(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)(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 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 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 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 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 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 measured at 2 years (± 7 days) post root canal filling.)
- Tooth Survival at 6 Months Follow Up(Measured at 6 months (± 7 days) post root canal filling.)
- Tooth Survival at 1 Year Follow Up(Measured at 1 year (± 7 days) post root canal filling.)
- Tooth Survival at 2 Years Follow Up(Measured at 2 years (± 7 days) post root canal filling.)