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S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
Sponsor: National University of Malaysia
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.
Official title: Effect of S-PRG Filler in Prevention White Spot Lesions During Orthodontic Treatment: A Randomized Control Trial
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2026-10
Completion Date
2028-01
Last Updated
2026-09-24
Healthy Volunteers
Yes
Interventions
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.
S-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
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.
Placebo - Normal Saline
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.
Locations (1)
Faculty of Dentistry, Universiti Kebangsaan Malaysia (UKM)
Kuala Lumpur, Malaysia