An interventional study of S-PRG Barrier Coat and S-PRG Barrier Coat + 5% Sodium Fluoride Varnish in White Spot Lesion of Tooth, Orthodontic Treatment and Enamel Demineralization, sponsored by National University of Malaysia. Not yet recruiting at 1 site in Malaysia. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by National University of Malaysia · Not applicable, Interventional, and Prevention
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.
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.
National University of Malaysia is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 5% sodium fluoride varnish as the active comparator during orthodontic treatment with fixed appliances.
Other: 5% sodium fluoride varnish
Participants receive the combined S-PRG Barrier Coat and 5% sodium fluoride varnish intervention during orthodontic treatment with fixed appliances.
Combination Product: S-PRG Barrier Coat + 5% Sodium Fluoride Varnish
Participants receive a placebo (normal saline) during orthodontic treatment with fixed appliances.
Other: Placebo - Normal Saline
Participants receive S-PRG Barrier Coat as the assigned preventive intervention during orthodontic treatment
Other: S-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.
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.
Occurrence of White Spot Lesions During 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.
Time frame: 12 months after initiation of orthodontic treatment
Comparative Effectiveness of S-PRG Filler and 5% Sodium Fluoride Varnish in Preventing White Spot Lesions Assessed by ICDAS-II
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.
Time frame: 12 months after initiation of fixed orthodontic treatment.
Comparative Effectiveness of S-PRG Filler and 5% Sodium Fluoride Varnish in Preventing White Spot Lesions Assessed by the Gorelick Index
To compare the effectiveness of S-PRG filler and 5% sodium fluoride varnish in preventing white spot lesions in patients undergoing fixed orthodontic treatment. White spot lesion severity will be assessed from standardized digital photographs using the Gorelick index.
Time frame: 12 months after initiation of fixed orthodontic treatment.
Comparative Effectiveness of S-PRG Filler and 5% Sodium Fluoride Varnish in Preventing White Spot Lesions Assessed by DIAGNOdent
To compare changes in DIAGNOdent fluorescence values between S-PRG filler and 5% sodium fluoride varnish groups during fixed orthodontic treatment.
Time frame: 12 months after initiation of Orthodontic treatment
Plan to share: No — Individual participant data will not be shared with other researchers because the study involves confidential participant information.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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