S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNational University of Malaysia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Patients receiving orthodontic brackets on at least the upper incisors and canines, with an anticipated treatment duration of at least 12 months.
Patients with any degree of malocclusion.
Patients without pre-existing white spot lesions on the teeth being assessed.
Disqualifiers
Previous history of fixed orthodontic treatment.
Presence of dental anomalies or developmental defects of enamel (DDE) on the labial surfaces of the teeth, including pre-existing fluorosis or enamel hypoplasia.
Presence of direct or indirect restorations on the labial surfaces of the teeth being assessed.
History of long-term antibiotic use.
Trial design
Design model
Parallel
Treatments tested in this trial
S-PRG Barrier Coat
Other interventionS-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
Combination productA 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
Other intervention5% 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
Other interventionNormal 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.
Treatment groups
144 Participants
are divided into 4 treatment groupsGroup A: 5% Sodium Fluoride VarnishActive comparator 1 intervention
Group B: S-PRG + 5% Sodium Fluoride VarnishExperimental treatment 1 intervention
Group C: Placebo-Normal SalinePlacebo comparator 1 intervention
Group D: S-PRG Barrier CoatExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 treatmentSecondary outcomes
1
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.Other outcomes
1
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.2
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 treatmentSponsors and contacts
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Source ClinicalTrials.gov
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