A Comparative Assessment of Orthodontic Treatment Outcomes Using the Quantitative Light-Induced Fluorescence Method
Condition: White Spot Lesion of Tooth; Orthodontic Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The aim of this 2-arm parallel trial was to evaluate enamel demineralization after an
      indirect bonding technique in comparison to a direct bonding technique group using the
      quantitative light-induced fluorescence method. Thirty-six patients who needed fixed
      orthodontic treatment were randomly separated into either the direct bonding group or the
      indirect bonding group. Eligibility criteria included moderate crowding in the maxillary and
      mandibular dental arch, good oral hygiene, absence of craniofacial anomalies, no previous
      orthodontic treatment and no deciduous, congenitally missing or extracted teeth.
      Randomization was made at the start of the study with a statistical analysis program (SAS
      Institute Inc., Cary, NC, USA.). For the patients in the indirect bonding group, bonding was
      performed with a flowable composite adhesive, while the patients in the direct bonding group
      received a bonding procedure with a conventional composite adhesive. Records were taken using
      quantitative light-induced fluorescence (QLF) with a Digital Biluminator (Inspektor Research
      Systems, Amsterdam, the Netherlands) in the pretreatment and posttreatment examination
      phases. The presence and extent of lesions on the buccal surfaces of all teeth, except the
      molar teeth, were assessed. The fluorescence loss, lesion area and percentage of fluorescence
      loss were determined using the system's software. The primary outcome of this study was
      evaluation of the effects of bonding techniques on white spot lesion formation by using the
      QLF method. Random sequence generation was performed with a computerized random 1:1
      allocation using block sizes of 4. It was not possible for the clinicians and their
      interventions to be blocked. The patients and the specialists were blinded to the treatment
      groups when their treatment groups were aware.
    

Detailed description: 
      This study was single center, one-blinded, 2-arm parallel, randomized clinical trial with a
      1:1 allocation ratio. No changes were made to the protocol after trial commencement.
      Initially, 60 patients who had been referred to a tertiary clinic in Kayseri, Turkey for
      orthodontic treatment between October 2011 and June 2013 were assessed for eligibility by the
      clinicians (A.Y.). The inclusion criteria for the experiment groups in this study were mild
      to moderate crowding in the maxillary and mandibular dental arch, good oral hygiene, absence
      of craniofacial anomalies, no previous orthodontic treatment and no deciduous, congenitally
      missing or extracted teeth. 60 patients were examined in the trial. Thirty-six patients were
      divided into groups with equal numbers of patients in each group. The study was completed
      with 31 patients. An analysis was performed on the 15 patients in the indirect bonding group
      and the 16 patients in the direct bonding group. Approval for the study was obtained from the
      Local Ethics Committee of the Faculty of Medicine at Erciyes University in Kayseri, Turkey
      (11-3585). Informed consent was obtained from all the patients included in the study. The
      consent was obtained from those over 18 years of age directly, and from the parents of those
      under 18 years of age. Standard treatment records, which are photographs, dental models and
      radiographs, were taken in the beginning of treatment and at the end of treatment from all
      patients included in the study. The patients were randomly allocated to 1 of 2 treatment
      groups: indirect bonding and direct bonding. In the direct bonding group, after the plaque
      structure on the teeth was cleaned with pumice and white elastic bur were etched with 37%
      phosphoric acid gel (3M-Dental Products, St Paul, Minnesota, USA) for 30 seconds, the teeth
      were rinsed and dried with oil-free compressed air for 15 seconds. After drying the enamel
      surface, the liquid primer Transbond XT (3M-Unitek, Monrovia, California, USA) was applied
      with a small brush and spread with oil-free compressed air. Pre-adjusted metal brackets which
      had values for the Roth prescription were then bonded using the conventional adhesive with a
      standard protocol and polymerized for 3 seconds per bracket with a multiwave light-emitting
      diode curing light.

      In the indirect bonding group, alginate was utilized to take impressions of the maxillary and
      mandibular arches, and hard dental stone was used to cast the dental models. Following the
      trimming and drying of the dental models dried, guidelines were drawn for vertical and
      horizontal bracket-positioning using a black pencil. The separating agent Al Cote (Dentsply
      Trubyte, York, Pennsylvania, USA) was administered onto the surfaces of the teeth surfaces
      using a brush, and the casts were left to dry. The same brackets used in the direct bonding
      technique were used. The composite adhesive was administered onto the base of the bracket,
      and the bracket was then placed onto the marked area on the tooth surface. The excess resin
      was carefully removed with a hand instrument. After positioning the bracket, the composite
      adhesive was polymerized with a multiwave light-emitting diode curing light. After
      positioning of the bracket on the transfer models, the composite adhesive was polymerized for
      3 seconds, and a 2-layer transfer tray was prepared using translucent soft silicone and
      thermoformed rigid Essix Plus plastic. The base of the brackets in the transfer tray was
      sandblasted to remove the separating agent. A flowable composite adhesive was applied to the
      bracket bases, and the transfer tray was then seated on the arch segment. The composite
      adhesive was polymerized for 3 seconds before and after removing the transfer tray. Excessive
      composite adhesive remnants were then removed using a tungsten carbide bur in an air rotor
      instrument. For all of the patients included in the study, orthodontic treatment and
      recommendations for how to use toothpaste containing fluoride, how to brush their teeth and
      diet habits were also added to reduce the number of white spot lesions and provide better
      treatment. The QLF images of all patients who underwent direct and indirect bonding were
      taken by the same observer in the beginning of fixed orthodontic treatment (T0) and
      immediately after removal of the appliances (T1) at the end of the treatment period using a
      QLF-D Biluminator 2-camera system (Inspektor Research Systems, Amsterdam, The Netherlands).
    

Intervention name(s): Quantitative Light-Induced Fluorescence; Direct bonding; Indirect bonding
Intervention type(s): Device; Procedure; Procedure
Intervention description(s): White spot lesion on the tooth surfaces detected with Quantitative Light-Induced Fluorescence Orthodontic Bonding.; The patients in the direct bonding group received a bonding procedure with a conventional composite adhesive.; For the patients in the indirect bonding group, bonding was performed with a flowable composite adhesive.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Random sequence generation was performed with a computerized random 1:1 allocation using block sizes of 4.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: White Spot Lesions; Direct Bonding; Indirect Bonding; Quantitative Light-Induced Fluorescence