White Spot Lesion of Tooth, Orthodontic Treatment, Enamel Demineralization, Fluoride Varnishes
Conditions
Keywords
White spot lesions, Orthodontic treatment, Enamel demineralization, S-PRG Barrier Coat, Surface Pre-Reacted Glass-ionomer, Remineralization, Fluoride varnish
Brief summary
White spot lesions are early areas of enamel demineralization that may develop during orthodontic treatment with fixed braces. This study aims to evaluate the effectiveness of S-PRG Barrier Coat in preventing white spot lesions during orthodontic treatment. The study will compare S-PRG Barrier Coat with 5% sodium fluoride varnish, a combination of S-PRG Barrier Coat and 5% sodium fluoride varnish, and a placebo. A total of 144 participants undergoing orthodontic treatment will be randomly assigned to one of four treatment groups. The occurrence and severity of white spot lesions will be assessed using clinical examinations, including the ICDAS-II and Gorelick index, together with DIAGNOdent readings where applicable. The study findings may help determine whether S-PRG Barrier Coat provides an effective preventive approach against orthodontic white spot lesions.
Detailed description
White spot lesions (WSLs) are early manifestations of enamel demineralization that may occur during orthodontic treatment with fixed appliances. Brackets and archwires can increase plaque accumulation and make oral hygiene more difficult, potentially increasing the risk of enamel demineralization. Although fluoride-based preventive measures are commonly used, additional preventive approaches may be beneficial. S-PRG (Surface Pre-Reacted Glass-ionomer) bioactive fillers have the potential to release various ions, including fluoride and strontium, which may contribute to the inhibition of demineralization and promotion of remineralization. S-PRG Barrier Coat is therefore being investigated as a potential preventive material for orthodontic WSLs. Study Objective The objective of this study is to evaluate the effect of S-PRG Barrier Coat in preventing white spot lesions during orthodontic treatment. Its preventive effect will be compared with 5% sodium fluoride varnish, a combination of S-PRG Barrier Coat and 5% sodium fluoride varnish, and a placebo. Study Design This is a single-center, four-arm, parallel-group, randomized controlled clinical trial involving patients undergoing orthodontic treatment with fixed appliances. A total of 144 participants will be recruited and randomly allocated in a 1:1:1:1 ratio to four treatment groups, with 36 participants planned for each group. Intervention Groups S-PRG Barrier Coat. 5% sodium fluoride varnish. Combined S-PRG Barrier Coat and 5% sodium fluoride varnish. Placebo. Study Procedures and Assessments Eligible participants will be recruited from the orthodontic clinic following assessment against the study inclusion and exclusion criteria. Written informed consent will be obtained before participation. Baseline assessments will be conducted according to the study protocol, followed by the application of the assigned intervention. Participants will be followed during orthodontic treatment to assess the occurrence and severity of WSLs. Clinical assessments will include the International Caries Detection and Assessment System (ICDAS-II) and the Gorelick index. DIAGNOdent readings may also be used as a diagnostic assessment of enamel demineralization, according to the approved study protocol. Clinical and diagnostic findings will be recorded and compared among the treatment groups. Randomization and Blinding Participants will be randomly allocated to one of the four treatment groups. The study is designed as a double-blind randomized controlled trial. The specific individuals blinded to treatment allocation will follow the approved study protocol. Expected Contribution This study may provide evidence on whether S-PRG Barrier Coat, alone or in combination with fluoride varnish, offers a preventive benefit against orthodontic WSLs compared with fluoride varnish alone and placebo. The findings may contribute to the development of preventive strategies for enamel demineralization during orthodontic treatment.
Interventions
OTHERS-PRG Barrier Coat
S-PRG Barrier Coat is a surface pre-reacted glass-ionomer (S-PRG) bioactive coating applied to tooth surfaces around orthodontic brackets according to the study protocol. It is intended to reduce enamel demineralization and prevent the development of white spot lesions during fixed orthodontic treatment.
COMBINATION_PRODUCTS-PRG Barrier Coat + 5% Sodium Fluoride Varnish
A combined preventive treatment consisting of S-PRG Barrier Coat and 5% sodium fluoride varnish applied according to the study protocol to reduce enamel demineralization and prevent the development of white spot lesions during fixed orthodontic treatment.
5% sodium fluoride varnish applied to the tooth surfaces according to the study protocol as an active comparator for prevention of enamel demineralization and development of white spot lesions during fixed orthodontic treatment.
Normal saline used as the placebo comparator and applied according to the study protocol to the tooth surfaces during fixed orthodontic treatment. The placebo is intended to provide a comparable application procedure without the active preventive components of the study interventions.
Sponsors
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Patients scheduled to undergo fixed orthodontic treatment at the Faculty of Dentistry, Universiti Kebangsaan Malaysia (UKM), who provide informed consent. For participants below 18 years of age, parental or guardian consent will be obtained. 2. Patients receiving orthodontic brackets on at least the upper incisors and canines, with an anticipated treatment duration of at least 12 months. 3. Patients with any degree of malocclusion. 4. Patients without pre-existing white spot lesions on the teeth being assessed. 5. Medically fit and healthy patients. 6. Non-smokers. 7. Patients who can understand and communicate in basic English or Bahasa Malaysia
Exclusion criteria
1. Previous history of fixed orthodontic treatment. 2. Presence of dental anomalies or developmental defects of enamel (DDE) on the labial surfaces of the teeth, including pre-existing fluorosis or enamel hypoplasia. 3. Presence of direct or indirect restorations on the labial surfaces of the teeth being assessed. 4. History of long-term antibiotic use. 5. Presence of untreated cavitated carious lesions, particularly involving the upper or lower incisors and canines. 6. Plaque level greater than 30%. 7. Known allergy to any component of the intervention materials, including sodium fluoride or glass ionomer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of White Spot Lesions During Orthodontic Treatment | 12 months after initiation of orthodontic treatment | The occurrence of white spot lesions will be assessed clinically using the International Caries Detection and Assessment System (ICDAS-II) and the Gorelick index. The presence or absence of white spot lesions will be compared among the four treatment groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparative Effectiveness of S-PRG Filler and 5% Sodium Fluoride Varnish in Preventing White Spot Lesions Assessed by ICDAS-II | 12 months after initiation of fixed orthodontic treatment. | To compare the effectiveness of S-PRG filler and 5% sodium fluoride varnish in preventing the occurrence of white spot lesions in patients undergoing fixed orthodontic treatment. White spot lesion occurrence will be assessed using the ICDAS-II scoring system. |
Countries
Malaysia
Contacts
CONTACTDAVEINTHIRAN THANABALAN, Bachelor of Dental Surgery
CONTACTNOOR SAM AHMAD, MOrth (UKM)
Outcome results
None listed