Clinical trial NCT06402500: Color Masking Potential of Bioactive and ICON Materials
Official title: The Color Masking Potentials of a Bioactive Glass Adhesive and the Resin ICON on the White Spot Lesions. A Comparative Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: White Spot Lesion of Tooth
Keywords: Resin infiltration
Incipient lesion
bioactive material
ICON infiltration resin
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth study design, patients will be assigned to two different treatment protocols.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: After sample size calculations were carried out a total sample size of 150 teeth will be included (75 teeth will be treated with ICON; and 75 other teeth will be treated with HI-Bond universal\].

Split mouth study design involves treating WSLs in two different quadrants in each participant. Treatments will be done according to manufacturer's instruction. The WSLs in the teeth of one quadrant will receive treatments with the ICON (DMG, America) , and the others in the opposite quadrant will receive treatments with the bioactive glass adhesive HI-Bond universal (MEDICLUS, south Korea).

Before receiving the treatment, the WSLs will be tested at baseline by Quantitative light-induced fluorescence (QLF) device then the test will be repeated at 1-month after the treatment for the quadrant that received bioactive glass adhesive.

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.

Primary outcomes:
measure: Color masking potential of ICON material in white spot lesions in permanent teeth.
timeFrame: 6 months
measure: Color masking potential of HI-Bond universal material in white spot lesions in permanent teeth.
timeFrame: 6 months
Secondary outcomes:
measure: The remineralisation potential of HI-Bond universal material of white spot lesion (WSL) in permanent teeth.
timeFrame: 3 months
measure: The remineralisation potential of HI-Bond universal material in the deepest point of the white spot lesion (WSL) in permanent teeth.
timeFrame: 3 months
measure: The remineralisation potential of HI-Bond universal material on lesion area (pixels) of white spot (WSL) in permanent teeth.
timeFrame: 3 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Zakereyya SM Albashaireh, PhD
role: PRINCIPAL_INVESTIGATOR
References: