Color Masking Potential of Bioactive and ICON Materials

White Spot Lesion of Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06402500
• Other study ID #: JUST
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: King Abdullah University Hospital
• Contact: Zakereyya SM Albashaireh, Ph.D
• Phone: 0096227201000
• Email: albashai[@]just.edu.jo
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• White Spot Lesion of Tooth

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Jordan	Jordan University of Science and Technology	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah University Hospital

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Color masking potential of ICON material in white spot lesions in permanent teeth.	Photographs will be taken before, immediately after treatment, and 1-month after treatment. These photographs will be used for evaluating of the esthetic outcome by two groups of subjects. The first group comprises the patients themselves. The second group includes dentists. Participants in the evaluation process will will be based on a 100-mm visual analogue scale (VAS). Participants will draw a line on the scale indicating their satisfaction. A line drawn between 0 - 5 cm will mean unsatisfactory outcome while that drawn between 5 - 10 cm will indicate satisfactory outcome.	6 months
Primary	Color masking potential of HI-Bond universal material in white spot lesions in permanent teeth.	Photographs will be taken before, immediately after treatment, and 1-month after treatment. These photographs will be used for evaluating of the esthetic outcome by two groups of subjects. The first group comprises the patients themselves. The second group includes dentists. Participants in the evaluation process will will be based on a 10-cm visual analogue scale (VAS). Participants will draw a line on the scale indicating their satisfaction. A line drawn between 0 - 5 cm will mean unsatisfactory outcome while that drawn between 5 - 10 cm will indicate satisfactory outcome.	6 months
Secondary	The remineralisation potential of HI-Bond universal material of white spot lesion (WSL) in permanent teeth.	Before receiving the HI-Bond material treatment, the WSL area will be measured by (QLF) device. The fluorescence intensities in the surrounding healthy enamel (baseline); and that in the white spot lesion are computed. The fluorescence loss is the difference of fluorescence intensities between the fluorescence of healthy enamel and that of the WSL.; The same procedure and calculations are repeated after one month of treating the WSL with HI-Bond universal material.; The fluorescence loss (?F) is typically reported as percentage (%) of fluorescence loss of that of the surrouding healthy enamel (baseline).	3 months
Secondary	The remineralisation potential of HI-Bond universal material in the deepest point of the white spot lesion (WSL) in permanent teeth.	Before receiving the HI-Bond material treatment, the WSL area will be measured by (QLF) device. Then, the QLF software identifies and quantifies the fluorescence intensity at the area of most significant demineralization within the lesion which is marked by the maximum fluorescence loss within the lesion when compared to that of the surrounding health enamel.; Deepest point in the lesion represents the maximum depth of fluorescence loss within the white spot lesion and is designated the symbol (?FMax).; The ?FMax represents the point within the white spot lesion where the demineralization is most severe, indicating the deepest point of mineral loss.; The same procedure and calculations are repeated after one month of treating the WSL with HI-Bond universal material.; Deepest point in the lesion (?FMax) is reported as a percentage (%) of fluorescence loss of that of surrounding healthy enamel (baseline).	3 months
Secondary	The remineralisation potential of HI-Bond universal material on lesion area (pixels) of white spot (WSL) in permanent teeth.	Before receiving the HI-Bond material treatment, the Lesion area of the WSL is manually selected using (QLF) device. Then, the software identifies pixels with reduced fluorescence intensity compared to that of healthy surrounding enamel.; The Lesion area (A?F) is calculated by summing the total number of demineralized pixels identified within the white spot lesion region. Each pixel represents a unit of area. The area is generally expressed in pixels² (px²) by the software associated with QLF device.; Through the software calibration this value can be converted into mm². The test will be repeated after 1-month of treatment with bioactive glass adhesive.; When reporting the Lesion area (A?F) in the context of QLF analysis, the unit is in pixels squared (px²).	3 months