Clinical Trials Directory

Trials / Completed

CompletedNCT03114475

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Damascus University · Academic / Other
Sex
All
Age
15 Years – 25 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
RADIATIONCO2 laser irradiationCO2 laser irradiation will be applied onto the enamel surrounding the orthodontic bracket
OTHERPlaceboNo irradiation is going to be applied in the intervention. Just a red light will be used as placebo.

Timeline

Start date
2016-06-15
Primary completion
2017-04-20
Completion
2017-09-01
First posted
2017-04-14
Last updated
2017-10-24

Locations

2 sites across 1 country: Syria

Source: ClinicalTrials.gov record NCT03114475. Inclusion in this directory is not an endorsement.