Clinical trial NCT03114475: Effect of CO2 Laser on Enamel White Spot Lesion Formation Around Orthodontic Brackets
Official title: Evaluation of Enamel Resistance to White Spot Lesion Formation Around Orthodontic Brackets After CO2 Laser Irradiation: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 25
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Split mouth design, the mouth will be split into four quadrants. Two quadrants will receive the active treatment, whereas the opposing two quadrants will receive the placebo.
Primary purpose: PREVENTION

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 description: 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).

Eligibility criteria: Inclusion Criteria:

* Adult patients with permanent occlusion at age 15-25 years.
* No previous orthodontic treatment
* Good oral hygiene
* Need to orthodontic treatment with fixed appliances

Exclusion Criteria:

* Patients with systemic diseases or syndromes
* Patients with existence of enamel fluorosis
* Patients with existence of amelogenesis imperfecta or hypocalcified enamel
* Patients with existence of restorations or crowns or carious lesions on the labial surfaces of teeth.
* Patients who received fluoride treatment within the last three months prior to being enrolled in the study.

Primary outcomes:
measure: Change in White Formation Status we will evaluate the degree of demineralization by DIAGNOdent Pen around the orthodontic brackets.
timeFrame: 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)
measure: Change in the Extent of White Spot Formation
timeFrame: 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)
measure: Change in the Percentage of White Spot Lesion Area
timeFrame: 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)
measure: Change in the degree of demineralization
timeFrame: The degree of demineralization will be evaluated at: t 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, University of Damascus Dental School
city: Damascus
country: Syrian Arab Republic
facility: Higher Institution for Laser Research and Applications
Study officials:
affiliation: MSc student, Department of Orthodontics, University of Damascus Dental School
name: Tuqa Raghis, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Senior Lecturer in Orthodontics, Department of Orthodontics, University of Damascus Dental School, Damascus, Syria
name: Ghiath Mahmoud, DDS MSc PhD
role: STUDY_DIRECTOR
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