White Spot Lesion
Conditions
Brief summary
The study is a clinical controlled trial. Ethical approval will be obtained from Imam Abdulrahman bin Faisal University, Dammam. The study participants will be recruited from the dental hospital and conducted between November 2020 to November 2020. This will be a single-center, randomized, single blinded with a 1:1:1 allocation ratio for the application of Icon® resin infiltration, MI Paste Plus and both treatments
Interventions
OTHERIcon® resin infiltration
low viscosity resin that can flow through the pores in the enamel surface
OTHERMI paste plus
s a superior form of fluoride ions as it also contains CPP-ACP, enhances mineral release without encouraging the formation of calculus.
Sponsors
Imam Abdulrahman Bin Faisal University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Patients who are willing and able to observe good oral hygiene and attend for the study visits. * Subjects with ≥1 visible and accessible early caries lesion present. * No prior white spot lesion treatment utilized except tooth brushing with fluoridated toothpaste.
Exclusion criteria
* Active carious lesions * Facial surface restorations * Deciduous teeth * Enamel alteration (fluorosis, opacity, hypocalcification, hypoplasia) * Intrinsic and extrinsic strains * Physically and mentally challenged volunteers * Patients with systemic diseases under medication * Smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Color improvements | Change from 0 day, 1 month and 6 months | Pre-treatment and post-treatment color changing (L\*A\*B values) of digital photographs using the Commission Internationale de l'Eclairage (CIE) system |
| Patient self satisfaction | Change from 0 day, 1 month and 6 months | Post-treatment patient satisfaction using the patient satisfaction scale |
| Change in lesion status | Change from 0 day, 1 month and 6 months | Post-treatment change in caries lesion status using ICDAS II |
| Cracks of enamel. | Change from 0 day, 1 month and 6 months | Number of cracks assessed by enamel surface analysis via silicone replicas using CLSM |
| Microbial composition. | Change from 0 day, 1 month and 6 months | Pre-treatment and post-treatment microbial composition of plaque samples. Samples will be stored at -80 °C until DNA extractions will be performed and run the 16S rRNA sequencing. |
| Effects on clinical parameter: sensitivity to percussion | Change from 0 day, 1 month and 6 months | Pre-treatment and post-treatment effects on sensitivity to percussion by end blunted instrument. |
| esthetic improvement | Change from 0 day, 1 month and 6 months | Esthetic improvement through objective assessments using a visual analogue |
| Patient esthetic self perception | Change from 0 day, 1 month and 6 months | Pre-treatment esthetic self perception by the subjects using questionnaire |
| change in lesion size | Change from 0 day, 1 month and 6 months | Pre-treatment and post-treatment white spot lesion size |
| fracture of enamel. | Change from 0 day, 1 month and 6 months | Number of fracture assessed by enamel surface analysis via silicone replicas using CLSM |
| Effects on clinical parameter: prolonged response to hot or cold. | Change from 0 day, 1 month and 6 months | Pre-treatment and post-treatment effects on response to hot or cold by cold test |
Countries
Saudi Arabia
Contacts
Primary Contactjumanah aljishi
Backup ContactNawarah Alaseef
Outcome results
None listed