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Postoperative Pain After Using Er,Cr,YSGG Lazer Irradiation During Root Canal Treatment

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Er,Cr:YSGG Laser
Sodium hypochlorite
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring root canal treatment, intracanal irrigation, Laser

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1)Single-rooted, maxillary and mandibular incisors, canines or premolars that were asymptomatic (no preoperative pain, swelling or acute endodontic or periodontal abscess). 2)Nonvital pulps and did not respond to cold testing.

3)People had no systemic diseases or allergies to local anesthetic agents . 4)People had not received any endodontic treatment previously. 5)People had no radiographic evidence of periapical bone loss.

Exclusion Criteria:

  1. Pregnant and breastfeeding women
  2. Patients taking analgesic, anti-inflammatory, or antibiotic medications during seven days prior to beginning of treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Er,Cr:YSGG Laser

    Sodium hypochlorite

    Arm Description

    In laser group, each root canal was dried with paper points and then Er,Cr:YSGG (Biolase™, Waterlase™, San Clemente, CA, USA) was used for intracanal disinfection with the following parameters: panel output power of 0,75 W, pulse frequency of 20 Hz, and 1% water pressure to 10% air pressure ratio laser with RFT3 tips (415 µm diameter radial firing tip RFT3 Endolase, Biolase Technology, Inc; calibration factor of 0.85). The fiber was placed at 1mm short of the WL. Irradiation was delivered along the entire length of the root canal with helicoradial movements, 1mm per seconds in speed. This procedure was repeated three times and kept for 20 seconds between each irradiation.

    In control group, each canal were irrigated with 6 ml of 2,5% NaOCl. For the final irrigation, 5 ml of sterile saline were used. During irrigation, needle was inserted 1 mm short of the WL.

    Outcomes

    Primary Outcome Measures

    Evaluation of Postoperative pain
    Postoperative pain evaluation with verbal analog scale after root canal treatment. Patients signed as 0: no pain; 1: mild pain, analgesic not required; 2: moderate pain, analgesic required; 3: severe pain, analgesic has no effect in relieving the pain. The data were collected and statistically analysed using by the numerical data. In this study, "0" and "1" scores are considered as better outcome. Patients who signed these scores didn't need to use analgesics. The worst outcome is considered as the patients signed "3". Each scale range for each time interval evaluated as count of patient and presented as percentage. Scale ranges are not summed.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 19, 2018
    Last Updated
    July 17, 2020
    Sponsor
    Cukurova University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03783520
    Brief Title
    Postoperative Pain After Using Er,Cr,YSGG Lazer Irradiation During Root Canal Treatment
    Official Title
    Postoperative Pain After Using Er,Cr: YSGG Laser Irradiation Versus NaOCl Irrigation: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (Actual)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cukurova University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Irrigation with sodium hypochlorite (NaOCl) during chemo-mechanic preparation for effective root canal disinfection is a standard protocol in root canal treatment. NaOCl is an alkali irrigant with pH 11.0 -12.0. Nearby its high antimicrobial efficacy, cytotoxic features make it questionable when it comes contact with periradicular tissues. Several irrigation materials were investigated less cytotoxic, more or equal antimicrobial to avoid such adverse effects. Calcium hypochlorite, chlorhexidine, chitosan and antibiotics are some of the chemicals tested. Laser is not a chemical but its action may show antibacterial effect. Studies showed that Er,Cr:YSGG laser is strongly antibacterial against Enterococcus faecalis biofilm. This antibacterial effect were frequently obtained with laser activated irrigation (LAI) or photon-induced photoacoustic streaming (PIPS) in the literature. The aim of this study was to evaluate whether disinfection procedure with laser provides more or less benefit in terms of postoperative pain when compared with the conventional NaOCl irrigation method.
    Detailed Description
    Both for maxillary and mandibular teeth, infiltration anesthesia were achieved by local anesthetic with 2 ml articaine hydrochloride with 1:200000 epinephrine (Maxicaine, VEM İlaç, Ist, Turkey). Endodontic access preparations were performed using diamond round burs. After the canals became visible, patency was checked with a K hand file (VDW, Munich, Germany), and a rubber dam was placed for isolation. The working length (WL) was determined with an electronic apex locator (Raypex 6, VDW) and accepted when three green bars were reached. A crown-down preparation technique was performed using Reciproc nickel-titanium instruments (VDW, Munich, Germany) R#50 according to the manufacturers' instruction until the WL. During the instrumentation procedures, the root canals were irrigated with 6 ml of 2,5% NaOCl between each file. In laser group, each root canal was dried with paper points and then Er,Cr:YSGG (Biolase™, Waterlase™, San Clemente, CA, USA) was used for intracanal disinfection with the following parameters: panel output power of 0,75 W, pulse frequency of 20 Hz, and 1% water pressure to 10% air pressure ratio laser with RFT3 tips (415 µm diameter radial firing tip RFT3 Endolase, Biolase Technology, Inc; calibration factor of 0.85). The fiber was placed at 1mm short of the WL. Irradiation was delivered along the entire length of the root canal with helicoradial movements, 1mm per seconds in speed. This procedure was repeated three times and kept for 20 seconds between each irradiation. In control group, each canal were irrigated with 6 ml of 2,5% NaOCl. For the final irrigation, 5 ml of sterile saline were used. During irrigation, needle was inserted 1 mm short of the WL. At the end of disinfection procedures, each root canal was dried with paper points and the largest gutta-percha cone that reached the WL without any resistance was used as the master cone. Measurements from the electronic apex locator were confirmed radiographically. In cases of discrepancies between the radiographic and electronic measurements, the latter was selected. All root canals were filled with gutta-percha and root canal sealer (Adseal Meta Biomed Co, Korea) using the lateral condensation technique. The teeth were coronally sealed with composite resin (Premise, Kerr, Salerno, Italy). After the completion of the root fillings, postoperative instructions were given to all patients and prescribed 200 mg ibuprofen only one tablet if it is needed within the 0- to 6-hour time interval after the treatment and then one for every 8 hours in the event of pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    root canal treatment, intracanal irrigation, Laser

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    170 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Er,Cr:YSGG Laser
    Arm Type
    Experimental
    Arm Description
    In laser group, each root canal was dried with paper points and then Er,Cr:YSGG (Biolase™, Waterlase™, San Clemente, CA, USA) was used for intracanal disinfection with the following parameters: panel output power of 0,75 W, pulse frequency of 20 Hz, and 1% water pressure to 10% air pressure ratio laser with RFT3 tips (415 µm diameter radial firing tip RFT3 Endolase, Biolase Technology, Inc; calibration factor of 0.85). The fiber was placed at 1mm short of the WL. Irradiation was delivered along the entire length of the root canal with helicoradial movements, 1mm per seconds in speed. This procedure was repeated three times and kept for 20 seconds between each irradiation.
    Arm Title
    Sodium hypochlorite
    Arm Type
    Active Comparator
    Arm Description
    In control group, each canal were irrigated with 6 ml of 2,5% NaOCl. For the final irrigation, 5 ml of sterile saline were used. During irrigation, needle was inserted 1 mm short of the WL.
    Intervention Type
    Device
    Intervention Name(s)
    Er,Cr:YSGG Laser
    Intervention Description
    Er,Cr:YSGG Laser is used for disinfection of the root canals.
    Intervention Type
    Other
    Intervention Name(s)
    Sodium hypochlorite
    Intervention Description
    Sodium hypochlorite is used for disinfection of the root canals
    Primary Outcome Measure Information:
    Title
    Evaluation of Postoperative pain
    Description
    Postoperative pain evaluation with verbal analog scale after root canal treatment. Patients signed as 0: no pain; 1: mild pain, analgesic not required; 2: moderate pain, analgesic required; 3: severe pain, analgesic has no effect in relieving the pain. The data were collected and statistically analysed using by the numerical data. In this study, "0" and "1" scores are considered as better outcome. Patients who signed these scores didn't need to use analgesics. The worst outcome is considered as the patients signed "3". Each scale range for each time interval evaluated as count of patient and presented as percentage. Scale ranges are not summed.
    Time Frame
    0-24 hours after root canal treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 1)Single-rooted, maxillary and mandibular incisors, canines or premolars that were asymptomatic (no preoperative pain, swelling or acute endodontic or periodontal abscess). 2)Nonvital pulps and did not respond to cold testing. 3)People had no systemic diseases or allergies to local anesthetic agents . 4)People had not received any endodontic treatment previously. 5)People had no radiographic evidence of periapical bone loss. Exclusion Criteria: Pregnant and breastfeeding women Patients taking analgesic, anti-inflammatory, or antibiotic medications during seven days prior to beginning of treatment.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23402273
    Citation
    Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12.
    Results Reference
    background
    PubMed Identifier
    20307752
    Citation
    Dewsnup N, Pileggi R, Haddix J, Nair U, Walker C, Varella CH. Comparison of bacterial reduction in straight and curved canals using erbium, chromium:yttrium-scandium-gallium-garnet laser treatment versus a traditional irrigation technique with sodium hypochlorite. J Endod. 2010 Apr;36(4):725-8. doi: 10.1016/j.joen.2009.11.017. Epub 2010 Feb 6.
    Results Reference
    background
    PubMed Identifier
    18718362
    Citation
    Figini L, Lodi G, Gorni F, Gagliani M. Single versus multiple visits for endodontic treatment of permanent teeth: a Cochrane systematic review. J Endod. 2008 Sep;34(9):1041-7. doi: 10.1016/j.joen.2008.06.009.
    Results Reference
    background
    PubMed Identifier
    25772335
    Citation
    Christo JE, Zilm PS, Sullivan T, Cathro PR. Efficacy of low concentrations of sodium hypochlorite and low-powered Er,Cr:YSGG laser activated irrigation against an Enterococcus faecalis biofilm. Int Endod J. 2016 Mar;49(3):279-86. doi: 10.1111/iej.12447. Epub 2015 Apr 1.
    Results Reference
    background

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    Postoperative Pain After Using Er,Cr,YSGG Lazer Irradiation During Root Canal Treatment

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