Clinical Trial: Effect of CO2 Laser on Enamel White Spot Lesion Formation Around Orthodontic Brackets

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Evaluation of Enamel Resistance to White Spot Lesion Formation Around Orthodontic Brackets After CO2 Laser Irradiation: A Randomized Controlled Clinical Trial

Brief Summary:

This study aims to evaluate the clinical effect of CO2 laser on enamel resistance to white spot lesions formation around orthodontic brackets.

25 patients needing fixed orthodontic treatment will participate in the study, the CO2 laser will be applied in a split mouth design around orthodontic brackets in two contrast quarters of mouth in every patient and the other quarters will serve as a control. The white spot lesion formation will be monitored around the brackets during the orthodontic treatment after four and twelve weeks of irradiation with laser.

Detailed Summary:

Prior to enrollment of each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide a written informed consent.

Before brackets' bonding (T0) the operator will evaluate with intraoral clinical examination and take intraoral photographs and evaluate with DIAGNOdent. Then after brackets' placement on teeth, the CO2 laser will be applied to the area of enamel about 2 mm of width around orthodontic brackets in a split mouth design. To blind the intervention sides on patients the control sides will receive nontherapeutic light.

Then intraoral photographs will be taken and the teeth will be assessed with DIAGNOdent (T1).

All patients will be trained to brush their teeth with a tooth paste containing 1100 ppm of fluoride twice a day. After 4 weeks of irradiation (T2) the patients will be examined for white spot lesions formation by clinical examination using Geiger index, photographic examination using AutoCAD 2009 evaluating formation and area percentage of white spot lesions, and the degree of demineralization will be assessed with DIAGNOdent. The all exams will also be done after 12 weeks of irradiation (T3).

Current Primary Outcome:

• Change in White Formation Status we will evaluate the degree of demineralization by DIAGNOdent Pen around the orthodontic brackets. [ Time Frame: The status of white spot formation will be judged at 10 minutes before taking the impressions (T0), five minutes following brackets' placement and irradiation (T1), at four weeks after laser irradiation (T2) and at twelve weeks after irradiation (T3) ]
  This will depend on the presence or absence of white spot formation assessed clinically.
• Change in the Extent of White Spot Formation [ Time Frame: Extent of white spot formation will be measured 10 minutes before taking the impressions (T0), five minutes following brackets' placement and irradiation (T1), at four weeks after laser irradiation (T2) and at twelve weeks after laser irradiation (T3) ]
  This will be assessed clinically using Geiger index (Step 1: no white spot lesions, Step 2: the white spot lesion is less than the third of the tooth surface area, Step 3: the white spot lesion is more than the third of the tooth surface area, Step 4: severe white spot lesions and caries)
• Change in the Percentage of White Spot Lesion Area [ Time Frame: Percentage of white spot lesion area will be assessed at 10 minutes before taking the impressions (T0), five minutes following brackets' placement and irradiation (T1), at four weeks after irradiation (T2) and at twelve weeks after irradiation (T3) ]
  This will be assessed using digital images.The percentage of white spot lesion area to the area of the labial surface of the tooth on digital images will be calculated using AutoCAD 2013 program.
• Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Damascus University
  

  Dates:
  Date Received: April 11, 2017
  Date Started: June 15, 2016
  Date Completion: July 2017
  Last Updated: May 9, 2017
  Last Verified: May 2017