White Spot Lesion of ToothSPRG-WSLNCT07839780
S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
A study testing S-PRG Barrier Coat, S-PRG Barrier Coat + 5% Sodium Fluoride Varnish and 5% sodium fluoride varnish in people with White Spot Lesion of Tooth and Orthodontic Treatment, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth, Orthodontic Treatment, Enamel Demineralization
- What is being tested?
- S-PRG Barrier Coat, S-PRG Barrier Coat + 5% Sodium Fluoride Varnish and 5% sodium fluoride varnish
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- Medically fit and healthy patients.
- Non-smokers.
- Patients who can understand and communicate in basic English or Bahasa Malaysia
Who cannot join
- 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.
- Presence of untreated cavitated carious lesions, particularly involving the upper or lower incisors and canines.
- Plaque level greater than 30%.
- Known allergy to any component of the intervention materials, including sodium fluoride or glass ionomer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
NOOR SAM AHMAD, MOrth (UKM) contact
Malaysia1 site
Faculty of Dentistry, Universiti Kebangsaan Malaysia (UKM)
Kuala Lumpur, 50300
About this study
Official title: Effect of S-PRG Filler in Prevention White Spot Lesions During Orthodontic Treatment: A Randomized Control 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.
Read the 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.
- Conditions
- White Spot Lesion of Tooth, Orthodontic Treatment, Enamel Demineralization, Fluoride Varnishes
- Being tested
- S-PRG Barrier Coat, S-PRG Barrier Coat + 5% Sodium Fluoride Varnish, 5% sodium fluoride varnish, Placebo - Normal Saline
- Keywords
- White spot lesions, Orthodontic treatment, Enamel demineralization, S-PRG Barrier Coat, Surface Pre-Reacted Glass-ionomer, Remineralization, Fluoride varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-PRG Barrier CoatOther
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 VarnishCombination product
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 varnishOther
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 SalineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 5% Sodium Fluoride Varnish | Active comparator | Participants receive 5% sodium fluoride varnish as the active comparator during orthodontic treatment with fixed appliances. Receives: Other: 5% sodium fluoride varnish |
| S-PRG + 5% Sodium Fluoride Varnish | Experimental | Participants receive the combined S-PRG Barrier Coat and 5% sodium fluoride varnish intervention during orthodontic treatment with fixed appliances. Receives: Combination Product: S-PRG Barrier Coat + 5% Sodium Fluoride Varnish |
| Placebo-Normal Saline | Placebo comparator | Participants receive a placebo (normal saline) during orthodontic treatment with fixed appliances. Receives: Other: Placebo - Normal Saline |
| S-PRG Barrier Coat | Experimental | Participants receive S-PRG Barrier Coat as the assigned preventive intervention during orthodontic treatment Receives: Other: S-PRG Barrier Coat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after initiation of orthodontic treatment
Secondary 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.
Measured: 12 months after initiation of fixed orthodontic treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for White Spot Lesion of ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Noor Sam bin Ahmad, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839780
- Sponsor's protocol ID
- JEP-2025-876.
- Acronym
- SPRG-WSL
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because the study involves confidential participant information.
Publications
Al Tuma, R. R. & Yassir, Y. A. 2023. Effect of calcium fluoride nanoparticles in prevention of demineralization during orthodontic fixed appliance treatment: a randomized clinical trial. Eur J Orthod 45(2): 122-132. Altenburger, M. J., Schirrmeister, J. F., Wrbas, K. T., Klasser, M. & Hellwig, E. 2008. Fluoride uptake and remineralisation of enamel lesions after weekly application of differently concentrated fluoride gels. Caries Res 42(4): 312-318. Amaechi, B. T., Kasundra, H., Joshi, D., Abdollahi, A., Azees, P. a. A. & Okoye, L. O. 2018. Effectiveness of S-PRG Filler-Containing Toothpaste in Inhibiting Demineralization of Human Tooth Surface. Open Dentistry Journal 12(811-819. Anderson, A. M., Kao, E., Gladwin, M., Benli, O. & Ngan, P. 2002. The effects of argon laser irradiation on enamel decalcification: An in vivo study. Am J Orthod Dentofacial Orthop 122(3): 251-259. Benham, A. W., Campbell, P. M. & Buschang, P. H. 2009. Effectiveness of pit and fissure sealants in reducing white spot lesions during orthodontic treatment. A pilot study. Angle Orthod 79(2): 338-345. Benjasuwantep, P., Rirattanapong, P. & Vongsavan, K. 2017.. Southeast Asian Journal of Tropical Medicine and Public Health 48(5): 1127-1132. Bishara, S. E. & Ostby, A. W. 2008. White Spot Lesions: Formation, Prevention, and Treatment. Seminars in Orthodontics 14(3): 174-182. Brown, M. D., Campbell, P. M., Schneiderman, E. D. & Buschang, P. H. 2016. A practice-based evaluation of the prevalence and predisposing etiology of white spot lesions. Angle Orthod 86(2): 181-186. Buchalla, W., Attin, T., Schulte-Mönting, J. & Hellwig, E. 2002. Fluoride uptake, retention and remineralization efficacy of a highly concentrated fluoride solution on enamel lesions . Journal of Dental Research 81(5): 329-333. Buren, J. L., Staley, R. N., Wefel, J. & Qian, F. 2008. Inhibition of enamel demineralization by an enamel sealant, Pro Seal: an in-vitro study. Am J Orthod Dentofacial Orthop 133(4 Suppl): S88-94. Chapman,
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of S-PRG Filler in Prevention White Spot Lesions During Orthodontic Treatment: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07839780
- Acronym / sponsor ID
- SPRG-WSL / JEP-2025-876.
- Conditions
- White Spot Lesion of Tooth, Orthodontic Treatment, Enamel Demineralization, Fluoride Varnishes
- Keywords
- White spot lesions, Orthodontic treatment, Enamel demineralization, S-PRG Barrier Coat, Surface Pre-Reacted Glass-ionomer, Remineralization, Fluoride varnish
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5% Sodium Fluoride Varnish | Active comparator | Other: 5% sodium fluoride varnishParticipants receive 5% sodium fluoride varnish as the active comparator during orthodontic treatment with fixed appliances. |
| S-PRG + 5% Sodium Fluoride Varnish | Experimental | Combination Product: S-PRG Barrier Coat + 5% Sodium Fluoride VarnishParticipants receive the combined S-PRG Barrier Coat and 5% sodium fluoride varnish intervention during orthodontic treatment with fixed appliances. |
| Placebo-Normal Saline | Placebo comparator | Other: Placebo - Normal SalineParticipants receive a placebo (normal saline) during orthodontic treatment with fixed appliances. |
| S-PRG Barrier Coat | Experimental | Other: S-PRG Barrier CoatParticipants receive S-PRG Barrier Coat as the assigned preventive intervention during orthodontic treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Medically fit and healthy patients.
Key exclusion criteria (7 listed)
- 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.
- Presence of untreated cavitated carious lesions, particularly involving the upper or lower incisors and canines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-PRG Barrier CoatS-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. | Other | S-PRG Barrier Coat |
| S-PRG Barrier Coat + 5% Sodium Fluoride VarnishA 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. | Combination product | S-PRG + 5% Sodium Fluoride Varnish |
| 5% sodium fluoride varnish5% 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. | Other | 5% Sodium Fluoride Varnish |
| Placebo - Normal SalineNormal 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. | Other | Placebo-Normal Saline |
Primary outcome
Occurrence of White Spot Lesions During Orthodontic Treatment
Time frame: 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.
1 secondary outcome
Comparative Effectiveness of S-PRG Filler and 5% Sodium Fluoride Varnish in Preventing White Spot Lesions Assessed by ICDAS-II
Time frame: 12 months after initiation of fixed orthodontic treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- BackgroundAl Tuma, R. R. & Yassir, Y. A. 2023. Effect of calcium fluoride nanoparticles in prevention of demineralization during orthodontic fixed appliance treatment: a randomized clinical trial. Eur J Orthod 45(2): 122-132. Altenburger, M. J., Schirrmeister, J. F., Wrbas, K. T., Klasser, M. & Hellwig, E. 2008. Fluoride uptake and remineralisation of enamel lesions after weekly application of differently concentrated fluoride gels. Caries Res 42(4): 312-318. Amaechi, B. T., Kasundra, H., Joshi, D., Abdollahi, A., Azees, P. a. A. & Okoye, L. O. 2018. Effectiveness of S-PRG Filler-Containing Toothpaste in Inhibiting Demineralization of Human Tooth Surface. Open Dentistry Journal 12(811-819. Anderson, A. M., Kao, E., Gladwin, M., Benli, O. & Ngan, P. 2002. The effects of argon laser irradiation on enamel decalcification: An in vivo study. Am J Orthod Dentofacial Orthop 122(3): 251-259. Benham, A. W., Campbell, P. M. & Buschang, P. H. 2009. Effectiveness of pit and fissure sealants in reducing white spot lesions during orthodontic treatment. A pilot study. Angle Orthod 79(2): 338-345. Benjasuwantep, P., Rirattanapong, P. & Vongsavan, K. 2017.. Southeast Asian Journal of Tropical Medicine and Public Health 48(5): 1127-1132. Bishara, S. E. & Ostby, A. W. 2008. White Spot Lesions: Formation, Prevention, and Treatment. Seminars in Orthodontics 14(3): 174-182. Brown, M. D., Campbell, P. M., Schneiderman, E. D. & Buschang, P. H. 2016. A practice-based evaluation of the prevalence and predisposing etiology of white spot lesions. Angle Orthod 86(2): 181-186. Buchalla, W., Attin, T., Schulte-Mönting, J. & Hellwig, E. 2002. Fluoride uptake, retention and remineralization efficacy of a highly concentrated fluoride solution on enamel lesions . Journal of Dental Research 81(5): 329-333. Buren, J. L., Staley, R. N., Wefel, J. & Qian, F. 2008. Inhibition of enamel demineralization by an enamel sealant, Pro Seal: an in-vitro study. Am J Orthod Dentofacial Orthop 133(4 Suppl): S88-94. Chapman,
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the study involves confidential participant information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
NOOR SAM AHMAD, MOrth (UKM) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-PRG Barrier Coat, S-PRG Barrier Coat + 5% Sodium Fluoride Varnish and 5% sodium fluoride varnish in people with White Spot Lesion of Tooth and Orthodontic Treatment, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DAVEINTHIRAN THANABALAN, Bachelor of Dental Surgery (+60173807427, p166299@siswa.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of White Spot Lesions During Orthodontic Treatment (time frame: 12 months after initiation of orthodontic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07839780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.