Caries Removal in Primary Teeth Using Er:YAG Laser
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective: To assess and compare the 2940 nm erbium:yttrium-aluminum-garnet (Er:YAG) laser
      versus a conventional rotary treatment during cavity preparation in children with regard to
      anxiety level, pain perception, restoration integrity, and bond interface quality.

      Materials and Methods: In a randomized, blinded trial using a split-mouth design, forty
      (9-12-year-old) children with 80 carious deciduous molars were included. The cavity in one
      quadrant was treated conventionally using a bur, while the cavity in the other quadrant was
      prepared using an Er:YAG laser. Venham's dental anxiety scale and pulse rate measurement
      using a fingertip pulse oximeter were used to evaluate dental anxiety levels. The Wong-Baker
      facial pain rating scale and the number of local anesthesia required during both
      interventions were further applied to investigate pain perception. At the 1-year follow-up,
      clinical examinations was conducted and the integrity of the restorations was clinically
      assessed according to the Ryge criteria. Lastly, the restored teeth were extracted and
      histologically evaluated for bond interface quality using scanning electronic microscopy.
    

Detailed description: 
      Study Design: A randomized, blinded split-mouth study was conducted with a sample of 40
      healthy children aged 9 to 12 years (N=40 children) / (n=80 teeth). The children were divided
      into two groups randomly. The first group included 20 children who were assigned to receive
      the conventional treatment at the first visit and the laser treatment at the second visit
      (N=20 children) / (n=40 teeth). The second group was assigned to receive the laser treatment
      at the first visit and the conventional treatment at the second visit (N=20 children) / (n=40
      teeth). Both groups received the laser and conventional treatment and were assessed for pain
      and anxiety during both interventions. After a follow -up period of 1 year, an analysis of
      the restorative integrity evaluation was performed using the Ryge criteria. The restored
      teeth were extracted according to the normal exfoliation schedule and analyzed for bond
      interface quality evaluation.

      Study Sample: Study participants were recruited from the patient population at the pediatric
      dentistry clinics at King Abdulaziz University Dental Hospital in Jeddah, Saudi Arabia. Every
      patient in the appropriate age range has been examined for class I carious lesions of the
      molars, and in patients where these molars were present, the researcher was notified by the
      practitioner. The researcher was to make the final decision about the suitability of patients
      to be included in the study sample. The researcher explained the study procedures to the
      parents of potential subjects, and if they agreed to participate, consent to participate in
      the study has been obtained from the parents of the pediatric patients.

      Sample Size Calculation: According to the authors' assumptions, a sample size of 31 pairs
      will have 80 percent power to detect a difference in proportions of restorations integrity of
      0.2 when the proportion of discordant pairs is expected to be 0.21, and the analysis method
      is a McNemar's test of equality of paired proportions with a 5% two-sided significance level.

      Randomization Procedure: Each patient has undergone conventional caries removal on one
      affected molar and laser caries removal on the other. The researcher prepared 80 sealed
      envelopes divided into two groups in 2 boxes, each containing 40 envelopes. The first group
      was for the treatment procedures randomization, 20 of which contained instructions to perform
      conventional caries removal on the first tooth and laser caries removal on the second, and
      other 20 contained instructions to use the laser on the first tooth and the rotary bur on the
      second. The second group for tooth randomization consisted of 40 envelopes, 20 of which
      contained instructions to treat the tooth in the right quadrant first, and 20 of which
      contained instructions to treat the tooth in the left quadrant first. The envelopes were
      identical from the outside, only the messages inside differed. The subjects, who did not know
      the contents of the envelopes, were asked to select two envelopes, one from each group. The
      researcher opened them and read the contents to be informed as to which treatment and which
      tooth would be performed first.

      Treatment Procedure: The conventional treatment and the laser treatment took place at two
      separate visits, approximately one week apart, with the order of the treatments to be
      determined by the randomization process. The teeth were restored using Clearfil Universal
      Bond Quick self-etching primer, bonding resin and Clearfil APX composite resin.

      One-Year-Follow-Up: Follow-up took place one year later, at which time clinical examination
      was conducted. The integrity of the restorations has been clinically examined. The examiner
      did not know which tooth had received which treatment. The restorations were evaluated
      according to Ryge criteria; the criteria published by the United States Public Health
      Service. The criteria that were measured included: anatomical form, axial contour, marginal
      contact, margin discoloration, secondary caries, and visible plaque. Each criterion received
      a numerical rating from zero to two (zero to three for some criteria) and a score of Alpha,
      Bravo, or Charlie (or Delta for marginal contact and axial contour.

      Teeth Extractions: The restored teeth were followed up for two more years and were extracted
      whenever it was determined that the root of the successor's tooth was formed (according to
      the normal tooth shedding time of the patient). The extracted teeth were evaluated for bond
      interface quality.
    

Intervention name(s): Er:YAG laser system (Doctor smile, Pluser, Italy); Master Torque high/low-speed air rotor handpiece (KaVo Dental, Charlotte, North Carolina, USA)
Intervention type(s): Device; Device
Intervention description(s): The Er:YAG laser offers a virtually painless alternative to conventional methods of caries removal, and its adoption in clinical practice could greatly reduce children's fear of going to the dentist. Caries removal is one of the leading reasons for dentist visits among children, and many children become fearful at the mere thought of a drill touching their teeth, before they even hear the sound. Laser caries removal could go a long way toward eliminating children's fear of going to the dentist; it is virtually painless, and most children are able to get through the entire procedure without needing local anesthesia.; Mechanical removal of carious lesions with a rotating handpiece and bur instruments is the most often used approach for treating dental caries because it is cost-effective, timesaving, and simple. However, these procedures have many drawbacks, including the potential for removing healthy tooth structures, vibration and noise, which can cause the patient anxiety and pain, thus necessitating local anesthesia.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, blinded split-mouth study. The children were randomly assigned into one of two groups randomly. The first group included were assigned to receive the conventional treatment at the first visit and the laser treatment at the second visit. The second group was assigned to receive the laser treatment at the first visit and the conventional treatment at the second visit.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment