White Spot LesionsNCT07770724
Effect of BG Versus RI on the Depth of WSL
A study testing Bioactive Glass (NovaMin), Resin Infiltration (ICON) and Fluoride Toothpaste in people with White Spot Lesions, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this in vitro study is to assess the mean lesion depth improvement and hardness of artificial white spot lesions by comparing the effects of bioactive glass toothpaste and resin infiltration (ICON). Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- Bioactive Glass (NovaMin), Resin Infiltration (ICON) and Fluoride Toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2026to 30 Mar 2027
- 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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Upper and lower premolars will be collected from patients undergoing extractions.
- The teeth should be healthy with no carious lesions.
- The crown and root morphology of teeth should be normal.
- The extracted premolar teeth of patients should have no history of previous dental treatment.
Who cannot join
- • Fractured premolars due to any cause.
- Loss of enamel due to parafunctional habits.
- Presence of enamel anomalies (amelogenesis imperfecta, hypoplasia etc.).
- Presence of stains, demineralization, decay, fluorosis and restorations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Islamic International Dental Hospital
Islamabad, Capital, 44000
Ulfat Bashir, MDS, ulfat.bashir@riphah.edu.pk
Ayesha Islam, MDS, +92 03332921271, ayeshaislam913@gmail.com
About this study
Official title: Effect of Bioactive Glass Versus Resin Infiltration (ICON) on the Depth of White Spot Lesions: An in Vitro Study
The aim of this in vitro study is to assess the mean lesion depth improvement and hardness of artificial white spot lesions by comparing the effects of bioactive glass toothpaste and resin infiltration (ICON).
Read the detailed description
White spot lesions are an adverse result of orthodontic treatment caused by poor oral hygiene. It is difficult to maintain oral hygiene during fixed orthodontic treatment.White spot lesions are subsurface enamel porosities due to demineralization of enamel. They are basically the early stages of caries and has milky white appearance. WSLs are usually formed four weeks after bracket placement.There are various methods for the treatment of white spot lesions. The invasive methods include crowns or veneers and microabrasion. The non-invasive methods are remineralizing agents like topical fluoride, bioactive glass, GC Tooth Mousse and resin infiltration material (ICON). Fluoride compounds are one of the first therapies for WSL. Fluoride varnishes inhibit the demineralization process and promotes the remineralization of enamel. The fluoride varnish forms the calcium fluoride on enamel surface and prolong the contact between fluoride and enamel.Previous studies have shown promising results achieved by bioactive glass as compared to other remineralizing agents. Resin infiltration has been introduced recently and there are few studies on the treatment of WSLs. The rationale of the study is to compare the effects of bioactive glass and resin infiltration through scanning electron microscopy and microhardness, as there is limited research on this topic. The purpose of this study is to compare and evaluate the lesion depth of artificial white spot lesions before and after the treatment with sodium fluoride varnish, bioactive glass and resin infiltration (ICON). The null hypothesis is that there are no significant differences among the three groups for the treatment of white spot lesions.
- Conditions
- White Spot Lesions
- Being tested
- Bioactive Glass (NovaMin), Resin Infiltration (ICON), Fluoride Toothpaste
- Keywords
- white spot lesions, orthodontic brackets, resin infiltration, Fluoride toothpaste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive Glass (NovaMin)Other
A carbonated beverage (Coca Cola, Pakistan ltd) will be used for artificial white spot lesion formation. The pH of the beverage will be 4-4.5 at 37ºC. The teeth will be immersed in demineralization solution for 4 weeks before treatment. The solution will be changed every 48 hrs. to keep the pH constant.
After demineralization specimens will be washed with distilled deionized water (DDW). The tooth will have a white spot lesion only on the buccal surface.
A sufficient amount of 5% bioactive glass (Biomin F T/P) was applied on the tooth surface for three minutes using a tooth brush. The toothpaste remained on the surface for an additional 30 minutes.
Resin Infiltration (ICON)Other
A carbonated beverage (Coca Cola, Pakistan ltd) was used for artificial white spot lesion formation. The pH of the beverage was 4-4.5 at 37ºC. The teeth were be immersed in demineralization solution for 4 weeks before treatment. The solution was changed every 48 hrs. to keep the pH constant.
After demineralization specimens were washed with distilled deionized water (DDW). The tooth would have a white spot lesion only on the buccal surface.
Resin infiltration (ICON) infiltration will be applied according to manufacture as following:
- Application of Icon Etch (15% HCL gel) for 2 minutes.
- Water rinsing and air drying for 30 sec.
- Application of Icon-dry (ethanol) for 30 sec.
- Air drying
- Application of Icon Infiltrant for 3 minutes.
- Light curing for 40 seconds.
Fluoride ToothpasteOther
A carbonated beverage (Coca Cola, Pakistan ltd) was used for artificial white spot lesion formation. The pH of the beverage will be 4-4.5 at 37ºC. The teeth were immersed in demineralization solution for 4 weeks before treatment. The solution was changed every 48 hrs. to keep the pH constant.
After demineralization specimens was washed with distilled deionized water (DDW). The tooth would have a white spot lesion only on the buccal surface.
The teeth were cleaned and dried first. 5% Sodium fluoride (Enamelist) varnish was applied on tooth surface with disposable tooth brush. The varnish remained undisturbed on teeth for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Bioactive glass | Active comparator | toothpaste for white spot lesions Receives: Other: Bioactive Glass (NovaMin) |
| Resin Infiltration(ICON) | Active comparator | Infiltration on the tooth surface to treat white spot lesions Receives: Other: Resin Infiltration (ICON) |
| Fluoride toothpaste | Placebo comparator | Fluoride content treats the white spot lesion Receives: Other: Fluoride Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scanning Electron Microscopy
Changes in baseline lesion depth were assessed using scanning electron microscopy. Scanning electron microscopy is used to assess lesion depth before and after treatment with remineralizing agents. Lesion depth is measured in microns. Comparison is made by calculating the average depth of treated samples against untreated demineralized control samples.
Measured: 4th week
Vickers Microhardness Test
Changes from baseline microhardness tests are used to measure changes in surface hardness before and after remineralization. Sound or artificially demineralized enamel (acid-etched or caries-like lesions) is tested first to set a control value. Agents like fluoride varnishes, CPP-ACP (Casein Phosphopeptide-Amorphous Calcium Phosphate), or bioactive glass are applied over cycles. The percentage surface hardness measures how much demineralized enamel is hardened after remineralization treatment relative to original healthy baseline.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionsStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulfat Bashir, MDS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770724
- Sponsor's protocol ID
- IIDC/IRC/2024 Ayesha Islam
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eckstein A, Helms HJ, Knosel M. Camouflage effects following resin infiltration of postorthodontic white-spot lesions in vivo: One-year follow-up. Angle Orthod. 2015 May;85(3):374-80. doi: 10.2319/050914-334.1. Epub 2014 Aug 15.
PubMed 25126675Shan D, He Y, Gao M, Liu H, Zhu Y, Liao L, Hadaegh F, Long H, Lai W. A comparison of resin infiltration and microabrasion for postorthodontic white spot lesion. Am J Orthod Dentofacial Orthop. 2021 Oct;160(4):516-522. doi: 10.1016/j.ajodo.2020.04.039. Epub 2021 Jul 31.
PubMed 34344556Meyer-Lueckel H, Paris S. Infiltration of natural caries lesions with experimental resins differing in penetration coefficients and ethanol addition. Caries Res. 2010;44(4):408-14. doi: 10.1159/000318223. Epub 2010 Aug 17.
PubMed 20714153Baeshen HA, Lingstrom P, Birkhed D. Effect of fluoridated chewing sticks (Miswaks) on white spot lesions in postorthodontic patients. Am J Orthod Dentofacial Orthop. 2011 Sep;140(3):291-7. doi: 10.1016/j.ajodo.2010.04.034.
PubMed 21889073Hu H, Feng C, Jiang Z, Wang L, Shrestha S, Su X, Shu Y, Ge L, Lai W, Hua F, Long H. Effectiveness of remineralising agents in prevention and treatment of orthodontically induced white spot lesions: a protocol for a systematic review incorporating network meta-analysis. Syst Rev. 2019 Dec 29;8(1):339. doi: 10.1186/s13643-019-1253-8.
PubMed 31884975Kannan A, Padmanabhan S. Comparative evaluation of Icon(R) resin infiltration and Clinpro XT varnish on colour and fluorescence changes of white spot lesions: a randomized controlled trial. Prog Orthod. 2019 Jun 17;20(1):23. doi: 10.1186/s40510-019-0276-y.
PubMed 31204437
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bioactive Glass Versus Resin Infiltration (ICON) on the Depth of White Spot Lesions: An in Vitro Study
- ClinicalTrials.gov ID
- NCT07770724
- Acronym / sponsor ID
- IIDC/IRC/2024 Ayesha Islam
- Conditions
- White Spot Lesions
- Keywords
- white spot lesions, orthodontic brackets, resin infiltration, Fluoride toothpaste
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 18 Aug 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.
The aim of this in vitro study is to assess the mean lesion depth improvement and hardness of artificial white spot lesions by comparing the effects of bioactive glass toothpaste and resin infiltration (ICON).
Detailed description
White spot lesions are an adverse result of orthodontic treatment caused by poor oral hygiene. It is difficult to maintain oral hygiene during fixed orthodontic treatment.White spot lesions are subsurface enamel porosities due to demineralization of enamel. They are basically the early stages of caries and has milky white appearance. WSLs are usually formed four weeks after bracket placement.There are various methods for the treatment of white spot lesions. The invasive methods include crowns or veneers and microabrasion. The non-invasive methods are remineralizing agents like topical fluoride, bioactive glass, GC Tooth Mousse and resin infiltration material (ICON). Fluoride compounds are one of the first therapies for WSL. Fluoride varnishes inhibit the demineralization process and promotes the remineralization of enamel. The fluoride varnish forms the calcium fluoride on enamel surface and prolong the contact between fluoride and enamel.Previous studies have shown promising results achieved by bioactive glass as compared to other remineralizing agents. Resin infiltration has been introduced recently and there are few studies on the treatment of WSLs. The rationale of the study is to compare the effects of bioactive glass and resin infiltration through scanning electron microscopy and microhardness, as there is limited research on this topic. The purpose of this study is to compare and evaluate the lesion depth of artificial white spot lesions before and after the treatment with sodium fluoride varnish, bioactive glass and resin infiltration (ICON). The null hypothesis is that there are no significant differences among the three groups for the treatment of white spot lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bioactive glass | Active comparator | Other: Bioactive Glass (NovaMin)toothpaste for white spot lesions |
| Resin Infiltration(ICON) | Active comparator | Other: Resin Infiltration (ICON)Infiltration on the tooth surface to treat white spot lesions |
| Fluoride toothpaste | Placebo comparator | Other: Fluoride ToothpasteFluoride content treats the white spot lesion |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Upper and lower premolars will be collected from patients undergoing extractions.
Key exclusion criteria (4 listed)
- • Fractured premolars due to any cause.
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 |
|---|---|---|
| Bioactive Glass (NovaMin)A carbonated beverage (Coca Cola, Pakistan ltd) will be used for artificial white spot lesion formation. The pH of the beverage will be 4-4.5 at 37ºC. The teeth will be immersed in demineralization solution for 4 weeks before treatment. The solution will be changed every 48 hrs. to keep the pH constant. After demineralization specimens will be washed with distilled deionized water (DDW). The tooth will have a white spot lesion only on the buccal surface. A sufficient amount of 5% bioactive glass (Biomin F T/P) was applied on the tooth surface for three minutes using a tooth brush. The toothpaste remained on the surface for an additional 30 minutes. | Other | Bioactive glass |
| Resin Infiltration (ICON)A carbonated beverage (Coca Cola, Pakistan ltd) was used for artificial white spot lesion formation. The pH of the beverage was 4-4.5 at 37ºC. The teeth were be immersed in demineralization solution for 4 weeks before treatment. The solution was changed every 48 hrs. to keep the pH constant. After demineralization specimens were washed with distilled deionized water (DDW). The tooth would have a white spot lesion only on the buccal surface. Resin infiltration (ICON) infiltration will be applied according to manufacture as following: * Application of Icon Etch (15% HCL gel) for 2 minutes. * Water rinsing and air drying for 30 sec. * Application of Icon-dry (ethanol) for 30 sec. * Air drying * Application of Icon Infiltrant for 3 minutes. * Light curing for 40 seconds. | Other | Resin Infiltration(ICON) |
| Fluoride ToothpasteA carbonated beverage (Coca Cola, Pakistan ltd) was used for artificial white spot lesion formation. The pH of the beverage will be 4-4.5 at 37ºC. The teeth were immersed in demineralization solution for 4 weeks before treatment. The solution was changed every 48 hrs. to keep the pH constant. After demineralization specimens was washed with distilled deionized water (DDW). The tooth would have a white spot lesion only on the buccal surface. The teeth were cleaned and dried first. 5% Sodium fluoride (Enamelist) varnish was applied on tooth surface with disposable tooth brush. The varnish remained undisturbed on teeth for 4 hours. | Other | Fluoride toothpaste |
Primary outcome
Scanning Electron Microscopy
Time frame: 4th week
Changes in baseline lesion depth were assessed using scanning electron microscopy. Scanning electron microscopy is used to assess lesion depth before and after treatment with remineralizing agents. Lesion depth is measured in microns. Comparison is made by calculating the average depth of treated samples against untreated demineralized control samples.
Vickers Microhardness Test
Time frame: 4th week
Changes from baseline microhardness tests are used to measure changes in surface hardness before and after remineralization. Sound or artificially demineralized enamel (acid-etched or caries-like lesions) is tested first to set a control value. Agents like fluoride varnishes, CPP-ACP (Casein Phosphopeptide-Amorphous Calcium Phosphate), or bioactive glass are applied over cycles. The percentage surface hardness measures how much demineralized enamel is hardened after remineralization treatment relative to original healthy baseline.
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 18 Aug 2026.
- Background: PubMed 25126675Eckstein A, Helms HJ, Knosel M. Camouflage effects following resin infiltration of postorthodontic white-spot lesions in vivo: One-year follow-up. Angle Orthod. 2015 May;85(3):374-80. doi: 10.2319/050914-334.1. Epub 2014 Aug 15.
- Background: PubMed 34344556Shan D, He Y, Gao M, Liu H, Zhu Y, Liao L, Hadaegh F, Long H, Lai W. A comparison of resin infiltration and microabrasion for postorthodontic white spot lesion. Am J Orthod Dentofacial Orthop. 2021 Oct;160(4):516-522. doi: 10.1016/j.ajodo.2020.04.039. Epub 2021 Jul 31.
- Background: PubMed 20714153Meyer-Lueckel H, Paris S. Infiltration of natural caries lesions with experimental resins differing in penetration coefficients and ethanol addition. Caries Res. 2010;44(4):408-14. doi: 10.1159/000318223. Epub 2010 Aug 17.
- Background: PubMed 21889073Baeshen HA, Lingstrom P, Birkhed D. Effect of fluoridated chewing sticks (Miswaks) on white spot lesions in postorthodontic patients. Am J Orthod Dentofacial Orthop. 2011 Sep;140(3):291-7. doi: 10.1016/j.ajodo.2010.04.034.
- Background: PubMed 31884975Hu H, Feng C, Jiang Z, Wang L, Shrestha S, Su X, Shu Y, Ge L, Lai W, Hua F, Long H. Effectiveness of remineralising agents in prevention and treatment of orthodontically induced white spot lesions: a protocol for a systematic review incorporating network meta-analysis. Syst Rev. 2019 Dec 29;8(1):339. doi: 10.1186/s13643-019-1253-8.
- Background: PubMed 31204437Kannan A, Padmanabhan S. Comparative evaluation of Icon(R) resin infiltration and Clinpro XT varnish on colour and fluorescence changes of white spot lesions: a randomized controlled trial. Prog Orthod. 2019 Jun 17;20(1):23. doi: 10.1186/s40510-019-0276-y.
- Individual participant dataSharing planned: No
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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.
Ulfat Bashir, MDS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioactive Glass (NovaMin), Resin Infiltration (ICON) and Fluoride Toothpaste in people with White Spot Lesions, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 4 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 18 Aug 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 Pakistan. 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 Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scanning Electron Microscopy (time frame: 4th week). The study lists 2 primary outcomes in all. 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 NCT07770724, which also lists 6 linked publications.
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 18 Aug 2026.