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
| Type | Name | Description |
|---|---|---|
| RADIATION | CO2 laser irradiation | CO2 laser irradiation will be applied onto the enamel surrounding the orthodontic bracket |
| OTHER | Placebo | No 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.