Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

The Color Masking Potentials of a Bioactive Glass Adhesive and the Resin ICON on the White Spot Lesions. A Comparative Clinical Trial

ID
Name
JUST
Description
The non cavitated white-spot lesion (WSL) occurs after sometime during fixed orthodontic treatments, and their treatment is mandatory before going into frank cavitation. The resin infiltration material (ICON, DMG, America) is considered to be the gold standard resin infiltrationmaterial used for WSL treatment. It is an efficient material in arresting WSLs and has high favorable esthetic recovery. Furthermore, biomaterials like bioactive glass adhesives HI-bond universal adhesive have always been used for replacement, repair and generation of dental hard tissues. The hypotheses of this study are: 1. There will be no differences in color masking effect on WSLs managed by bioactive glass adhesive or ICON resin infiltration. 2. There will be no significant addition of mineral content into WSLs after treating it with bioactive glass adhesive HI-Bond universal or with ICON.
Trial arms
Trial start
2023-12-01
Estimated PCD
2024-09-30
Trial end
2024-12-31
Status
Recruiting
Treatment
Icon Infiltrant
White spot lesions are treated with the resin ICON (DMG, NJ, US) for masking their color. The mineral content will be measured in the lesion at baseline and after one month Quantitative light-induced fluorescence QLF.
Arms:
ICON resin group
Other names:
ICON (DMG, NJ, US)
Bioactive infiltrant
White spot lesions are treated with HI-Bond universal bioactive resin (MEDICLUS, south Korea) for masking their color. Mineral content will be measured in the lesion at baseline and after one month Quantitative light-induced fluorescence QLF.
Arms:
Bioactive resin group
Other names:
MEDICLUS, Cheongju-si, south Korea
Size
75
Primary endpoint
Color masking potential of ICON material in white spot lesions in permanent teeth.
6 months
Color masking potential of HI-Bond universal material in white spot lesions in permanent teeth.
6 months
Eligibility criteria
Inclusion Criteria: Patients with teeth and WSL fullfiling the following criteria will be included in the study: 1. Anterior and premolar maxillary and mandibular teeth. 2. Teeth with no previous restorations. 3. post-orthodontic white spot lesions WSL with no adjacent restorations in the same tooth. 4. WSL on Labial surfaces of maxillary or mandibular anterior and premolars teeth. Exclusion Criteria: The following will be excluded from the study, 1. Cavitated enamel surface that requires direct composite restorations. 2. Presence of developmental enamel defects on the proposed teeth. 3. Diabetic patients and patients with metabolic syndrome. 4. Pregnant ladies. 5. Smoker patients.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split mouth study design, patients will be assigned to two different treatment protocols.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The patients who participated in the study and the assessor of the treatment outcome did not know the type of treatment procedure received.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}
Updated at
2024-05-07

1 organization

2 products

1 indication

Organization
King Abdullah University Hospital
Product
Icon Infiltrant
Indication
Dental Caries
Product
Bioactive infiltrant