White Spot Lesion of ToothNCT07715942
Effect of Bioactive Resin Material Containing S-PRG Filler on White Spot Lesions
A study testing Bioactive resin composite containing S-PRG filler and Conventional flowable composite is used for the attachments for the clear orthodontic aligners in people with White Spot Lesion of Tooth, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
the effect of bioactive resin composite containing S-PRG filler will be tested as the material of choice for attachments bonded on teeth prior to the use of orthodontic clear aligners compared to the conventionally used flowable composite material for the prevention of white spot lesions on enamel tooth surfaces Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- Bioactive resin composite containing S-PRG filler and Conventional flowable composite is used for the attachments for the clear orthodontic aligners
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 13 Jul 2025to 23 Dec 2026
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adult orthodontic patients
- Class 1 malocclusion with mild to moderate crowding (<6 mm).
- Non extraction treatment plan.
- Optimum oral Hygiene before treatment.
- A maximum of three restored teeth with either fillings or prosthesis.
Who cannot join
- Patients with defective enamel, fluorosis, hypocalcification or enamel hypoplasia.
- Extensive restorations.
- Syndromes and Oro-facial anomalies.
- Salivary gland diseases.
- Patients who are pregnant, diabetic, or using mouth rinses or interacting medications, including antibiotic therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bioactive Resin Material Containing S-PRG Filler on White Spot Lesions: A Randomized Controlled Clinical Trial
the effect of bioactive resin composite containing S-PRG filler will be tested as the material of choice for attachments bonded on teeth prior to the use of orthodontic clear aligners compared to the conventionally used flowable composite material for the prevention of white spot lesions on enamel tooth surfaces
- Conditions
- White Spot Lesion of Tooth
- Being tested
- Bioactive resin composite containing S-PRG filler, Conventional flowable composite is used for the attachments for the clear orthodontic aligners
- Keywords
- Clear aligners, Bioactive resin, Composite containing S-PRG filler, QLF, Clear aligners, Bioactive resin, Composite containing S-PRG filler, Quantitative Light-Induced Fluorescence (QLF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive resin composite containing S-PRG fillerOther
Bioactive resin composite containing S-PRG filler is used as attachment material for the orthodontic clear aligners
Conventional flowable composite is used for the attachments for the clear orthodontic alignersOther
Conventional flowable composite is used for the attachments for the clear orthodontic aligners
| Study group | Role | What they receive |
|---|---|---|
| Bioactive resin Composite containing S-PRG filler | Experimental | Bioactive resin Composite containing S-PRG filler is used for the attachments for the clear orthodontic aligners Receives: Other: Bioactive resin composite containing S-PRG filler |
| Conventional flowable composite | Placebo comparator | Conventional flowable composite is used for the attachments for the clear orthodontic aligners Receives: Other: Conventional flowable composite is used for the attachments for the clear orthodontic aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
White spot lesion area
It measures the area of enamel demineralization (in pixels) using QLF system
Measured: 6 months
Mean of fluorescence loss (Delta F)
It measures the percentage of fluorescence loss in the white spot lesion compared to that of sound reflecting the amount of mineral loss using QLF system
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start13 Jul 2025
- Primary completion20 Aug 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology/Deanship of Scientific Research
- Responsible party
- Sponsor
- Investigators
- Susan Al-Khateeb, Study director, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715942
- Sponsor's protocol ID
- JUST20250049
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bioactive Resin Material Containing S-PRG Filler on White Spot Lesions: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07715942
- Acronym / sponsor ID
- JUST20250049
- Conditions
- White Spot Lesion of Tooth
- Keywords
- Clear aligners, Bioactive resin, Composite containing S-PRG filler, QLF, Clear aligners, Bioactive resin, Composite containing S-PRG filler, Quantitative Light-Induced Fluorescence (QLF)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology/Deanship of Scientific Research
- Study start
- 13 Jul 2025 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 21 Jul 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 effect of bioactive resin composite containing S-PRG filler will be tested as the material of choice for attachments bonded on teeth prior to the use of orthodontic clear aligners compared to the conventionally used flowable composite material for the prevention of white spot lesions on enamel tooth surfaces
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive resin Composite containing S-PRG filler | Experimental | Other: Bioactive resin composite containing S-PRG fillerBioactive resin Composite containing S-PRG filler is used for the attachments for the clear orthodontic aligners |
| Conventional flowable composite | Placebo comparator | Other: Conventional flowable composite is used for the attachments for the clear orthodontic alignersConventional flowable composite is used for the attachments for the clear orthodontic aligners |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy young adult orthodontic patients
- Class 1 malocclusion with mild to moderate crowding (<6 mm).
- Non extraction treatment plan.
- Optimum oral Hygiene before treatment.
- A maximum of three restored teeth with either fillings or prosthesis.
Key exclusion criteria (5 listed)
- Patients with defective enamel, fluorosis, hypocalcification or enamel hypoplasia.
- Extensive restorations.
- Syndromes and Oro-facial anomalies.
- Salivary gland diseases.
- Patients who are pregnant, diabetic, or using mouth rinses or interacting medications, including antibiotic therapy.
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 resin composite containing S-PRG fillerBioactive resin composite containing S-PRG filler is used as attachment material for the orthodontic clear aligners | Other | Bioactive resin Composite containing S-PRG filler |
| Conventional flowable composite is used for the attachments for the clear orthodontic alignersConventional flowable composite is used for the attachments for the clear orthodontic aligners | Other | Conventional flowable composite |
Primary outcome
White spot lesion area
Time frame: 6 months
It measures the area of enamel demineralization (in pixels) using QLF system
Mean of fluorescence loss (Delta F)
Time frame: 6 months
It measures the percentage of fluorescence loss in the white spot lesion compared to that of sound reflecting the amount of mineral loss using QLF system
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 21 Jul 2026.
- Individual participant dataSharing planned: No. The data will be shared upon reasonable request
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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. This study is not recruiting at the moment.
Susan Al-Khateeb study director
Jordan University of Science and Technology
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 resin composite containing S-PRG filler and Conventional flowable composite is used for the attachments for the clear orthodontic aligners in people with White Spot Lesion of Tooth, run by Jordan University of Science and Technology at 1 site in Jordan.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 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 Jordan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White spot lesion area (time frame: 6 months). 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?
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 21 Jul 2026.