Caries; Initial Clinical Trial
Official title:
Caries Inhibition With CO2-Laser During Orthodontic Treatment
The aim of the study is to assess the viability and efficacy of carbon dioxide laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances.
Status | Not yet recruiting |
Enrollment | 41 |
Est. completion date | August 1, 2023 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion Criteria: - Participants in the study are children ages 12 and older, in good general health - Children, requiring fixed orthodontic treatment (brackets) - Children at high caries risk according to 'Oral disease risk assessment tool' accepted and used in the Department of Paediatric Dentistry, Faculty of Dental medicine, Medical University - Plovdiv, Bulgaria - Children with untreated non-carious vestibular surfaces of the six maxillary anterior teeth of the permanent dentition (central and lateral incisors, canines) with ICDAS code 0 - Verbal assent from the child willing to comply with all study procedures and protocol - Obtained written informed consent by the patient's parent/guardian for participation in the study Exclusion Criteria: - Children with systemic diseases that may affect oral health or oral microflora (such as diabetes, etc.) - Children with medication intake that could affect the salivary flow or oral microflora (such as antibiotics, etc.) - Children with mental or cognitive problems - Patients with maxillary anterior permanent teeth affected by disturbances in the development of dental structures (hypoplasia, hypomineralization, fluorosis) |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria | Plovdiv | |
Bulgaria | Medical University - Plovdiv, Bulgaria | Plovdiv |
Lead Sponsor | Collaborator |
---|---|
Plovdiv Medical University |
Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes into International Caries Detection and Assessment System (ICDAS) codes | The International Caries and Detection System (ICDAS) is a visual scoring system developed for use in clinical assessment and clinical research of caries development and progression. It uses a numbered scoring system with a range from 0 to 6, to grade enamel demineralization and cavitation. Code of '0' represents unaffected/sound enamel, no caries change, '1' - first visual change, represents initial demineralization that is visible only after air drying, '2' represents a distinct visual change in the enamel that is visible when the surface is wet, '3' represents localized enamel loss or breakdown, no visible dentin or underlying shadow, and '4-6' represent larger carious lesions in dentin. | 1 year | |
Secondary | Changes in SoproLife ® scores | The SOPROlife score is a visual assessment of the caries levels. The SoproLife ® daylight intraoral camera (SoproLife ® Daylight mode) is used to record an intraoral picture with Sopro-imaging software (Acteon, Sopro, La Ciotat, France). The SoproLife ® blue fluorescence mode scores range from 0 to 5. Code of '0' is given when the surface appears shiny green, the enamel appears sound, and there are no visible changes, code '1' - a tiny, thin red shimmer is observed, no red dots appeared, code '2' - darker red spots are visible, code '3' - dark red spots have extended, a slight beginning roughness of the red areas can be visible, and codes '4-6' represent larger carious lesions in dentin. | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05094492 -
Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride
|
N/A | |
Recruiting |
NCT05969756 -
Early Treatments for Preventing Occlusal Caries Lesions
|
N/A | |
Not yet recruiting |
NCT04929327 -
Retention Rate of Self-etch Resin Based Sealant With and Without Prior Sandblasting
|
N/A | |
Not yet recruiting |
NCT05891288 -
Sealing of Initial Occlusal Caries Using Fissure Sealants
|
N/A | |
Completed |
NCT05127356 -
Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II
|
||
Recruiting |
NCT04092296 -
Efficacy of Resin Infiltration of Proximal Caries
|
N/A |