Clinical Study of Laser Analgesia in Cavity Preparations Using the Er,Cr:YSGG Laser
Condition: Tooth Pain
MeSH terms: Toothache
Study type: Interventional

Summary: 
      Not much has been done in research to explain the clinical benefit of laser cavity
      preparation without the use of injection anesthetic. The Author of this study sought to show
      the science behind the "no shot, no pain" in restorative dentistry using an Er,Cr:YSGG laser
      Patients with two similar size lesions of class I or class V cavities selected as subjects.
      In the same appointment, both cavities are prepared by the Er,Cr:YSGG. One lesion was
      prepared with one high power laser setting to ablate the enamel, dentin, and caries. The
      other lesion was prepared with a low power setting to start and is aimed at applying low
      level laser therapy (LLLT) before using the high power setting to ablate enamel, dentin, and
      caries. A visual analog scale (VAS) was used for the patient to analyze how comfortable each
      laser technique was. An Analysis of Variance (ANOVA) was used.
    

Detailed description: 
      The principal objective of this study is to prove the phenomenon of laser analgesia.
      Traditionally before a cavity preparation is performed, the doctor will use local anesthetic
      (Needle Injection) before using rotary instrument to do a cavity preparation. The study
      involves using the Er,Cr=YSGG Laser to perform cavity preparation without giving any
      injection anesthesia. VAS (Visual Analog Scale) will be used to have patients rate the laser
      cavity preparation procedure to show there is laser analgesia. On each patient subject that
      has two similar size cavities of the same classification, either Class I or Class V, on
      similar teeth. Two different laser protocols will be used. One includes Low Level Laser
      Therapy (LLLT) to condition the pulp producing analgesia before using higher power to perform
      the cavity prep. The other protocol will skip the LLLT setting and prepare the cavity with
      the higher power to perform the cavity prep. The design of the study is to find out if there
      is laser analgesia and if LLLT makes a difference in providing better analgesia. The VAS
      forms from each procedure will be used to show there is laser analgesia and potentially
      cavity preparations can be performed by using the laser without the need to give injection
      anesthesia first. 48 patients will be included in this study.

      Treatment. Preconditioning and cavity preparation are done using the Er:Cr:YSGG laser,
      Waterlase MD (mfg: Biolase Technology Inc, Irvine CA), and the gold hand piece with an MG6
      fiber tip, trunk fiber, contra-angle hand piece. Preconditioning. Preconditioning is
      preformed using laser desensitization. One tooth will be randomly selected, and
      preconditioning will be performed using LLLT on the tooth with minimal tooth ablation. The
      LLLT settings that will be used for preconditioning are 0.25 Watts, 50 Hz, 0% water, 0% air,
      H mode. Following this a fiber-optic tip will be aimed perpendicular to the surface of the
      cervical portion of the tooth, ensuring that a 2mm distance will be maintained between the
      end of the fiber optic tip and the surface. The fiber-tip will be used to generate a 2mm
      line. The cavity on the second tooth will be prepared for without laser preconditioning.
      Lesion Preparation - small preparations. Small preparations are to be performed as follows.
      The Waterlase MD is set to 4.5W, 15 Hz, 65% air, and 60% water and the cavity is prepared
      according to the preferred technique. If patients indicate sensitivity, the procedure will be
      halted, patients fill out the VAS form and anesthetic will be offered. For patients who
      refuse anesthetic, the procedure will be continued at the same settings. Lesion Preparation -
      small to medium preparations. Small to medium preparations will be performed as follows. The
      Waterlase MD will be set to 2W, 15 Hz, 65% air, and 60% water and the cavity will be prepared
      according to the preferred technique. If patients indicate sensitivity, the procedure will be
      halted, patients fill out the VAS form and anesthetic will be offered. For patients who
      refuse anesthetic, the procedure will be continued at the same settings.

      Restoration. Overall VAS Score. Up to 3 intra-operative VAS measurements are recorded. If a
      patient feels even the slightest amount of pain during the procedure, they will be instructed
      to raise their hand and the treatment will be paused. The patient is then asked to fill in
      the VAS form before the procedure will be continued. After conclusion of the cavity
      preparation, patients will be asked to mark one last VAS rating indicating the overall pain
      of the procedure. Patients that do not raise their hand throughout the entirety of the
      procedure will be given an overall VAS rating of zero. Data for each patient will be recorded
      and analyzed in this way.

      The VAS scale will be presented to the patients using a standard explanation (zero,
      indicating no pain at all, to 100, representing the 'worst pain patient had ever felt').
      Patients will be asked to place a vertical line on the VAS scale to indicate his/her
      discomfort status. They are encouraged to stop the treatment if they encounter any pain. The
      number of hand raises, as defined by the protocol, will be recorded and analyzed (small and
      medium/large preparations are analyzed separately), represent the number of times during the
      procedure the patient felt sufficient discomfort to stop the procedure. VAS data will be
      assessed by the following assumptions: The 'lower' the average score, the 'better' the mode
      of treatment. Once the patient marks their vertical line on the scale, a precise measurement,
      in millimeters, was taken from the "zero" line of the VAS scale to where the patient marked
      their line.
    

Intervention name(s): Er,Cr:YSGG Laser
Intervention type(s): Device
Intervention description(s): Patients with towo similar size lesions of either Class I or class v cavities selected as subjects. in the same appointment, both cavities are prepared by the Er'Cr:YSGG. one lesion was prepared with high power laser setting first to ablate the enamel, dentin, and caries. the other lesion was prepared with low power setting to start and is aimed at applying low level laser therapy (LLLT) first before using high power.
Other intervention name(s): Iplus laser
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care