White Spot Lesion of ToothNCT07818655
Effect of Diode Laser With Dye and Remineralizing Agent on Surface Area of White Spot Lesions by Using Digital Subtraction Radiograph Techniques.
A study testing remin pro in people with White Spot Lesion of Tooth, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The current study was conducted to compare effect of diode laser and perio green dye with reminerlizing agent on surface area white spot lesions by using digital subtraction radiographic techniques. Read more about this study
- Who is it for?
- Ages 13 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- remin pro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2022to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The patients should be 13e40 years old. The patients should have good oral hygiene, general health, and no systemic disease.
Who cannot join
- presence of enamel hypoplasia, dental fluorosis, and carious cavity. These patients have diminished salivary flow or significant tooth wear, and concurrent participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Diode Laser and Dye With Remineralizing Agent on Surface Area of White Spot Lesions by Using Digital Subtraction Radiograph Techniques. Randomized Clinical Trial
The current study was conducted to compare effect of diode laser and perio green dye with reminerlizing agent on surface area white spot lesions by using digital subtraction radiographic techniques.
Read the detailed description
A single-blinded, parallel-group, randomized clinical trial design was followed. 90 teeth with white spot lesions (WSLs) were selected from 30 patients. The participants were randomly assigned into six groups (n=15/group) according to the applied treatment agent (Remin Pro, X Pur Remin, and Pro-fluoride varnish) with diode laser (an average power of 1W, Exposure time of 10 s, diode 810 nm, speed of 1 mm/sec), and Elexxion Perio Green dye or without diode laser
- Conditions
- White Spot Lesion of Tooth
- Being tested
- remin pro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remin proDrug
Also called xpur remin
effect of diode laser and perio green dye with reminerlizing agent on surface area white spot lesions by using digital subtraction radiographic technique
| Study group | Role | What they receive |
|---|---|---|
| fluoride group | Active comparator | The first group (A1B1): The teeth with WSLs were treated with fluoride varinsh with laser application. Receives: Drug: remin pro |
| The teeth with WSLs were treated with Remin Pro with laser application | Active comparator | The teeth with WSLs were treated with Remin Pro with laser application. The second group (A1B2): The contralateral teeth were treated with Remin Pro without laser application. Receives: Drug: remin pro |
| Xremin pur | Active comparator | The teeth with WSLs were treated with Xremin pur with laser application. Receives: Drug: remin pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
surface area measurement white spot lesion (image anylsis)
The I sensor was a USP-driven digital sensor intended to acquire dental intraoral radiograph images. It was combined with the customized poisoning device supplied with the system. One month after the finalization of the remineralization protocol, another radiographic examination was undertaken. Before subtraction, gamma correction was applied to standardize the density and contrast, and images were obtained and saved as Tagged Image File Format (TIFF) and jpg. used image software for each area (Image J software), and follow-up images were subtracted from the base
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start5 May 2022
- Primary completion5 Jun 2022
- Study completion20 Apr 2023
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.
- More trials run by Al-Azhar 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first group (A1B1): The teeth with WSLs were treated with Remin Pro with laser application. The second group (A1B2): The contralateral teeth were treated with Remin Pro without laser application.The third group (A2B1): The teeth with WSLs were treated with X Pur Remin with laser application. The fourth group (A2B2): The contralateral teeth were treated with X Pur Remin without laser application. The fifth group (A3B1): The teeth with WSLs were treated with Pro Fluoride Varnish with laser application. The sixth group (A3B2): The contralateral teeth were treated with Pro-Fluoride Varnish without laser.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani abdullah Omar bin shahna, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818655
- Sponsor's protocol ID
- REC-OP-26-01
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diode Laser and Dye With Remineralizing Agent on Surface Area of White Spot Lesions by Using Digital Subtraction Radiograph Techniques. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07818655
- Acronym / sponsor ID
- REC-OP-26-01
- Conditions
- White Spot Lesion of Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 14 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.
The current study was conducted to compare effect of diode laser and perio green dye with reminerlizing agent on surface area white spot lesions by using digital subtraction radiographic techniques.
Detailed description
A single-blinded, parallel-group, randomized clinical trial design was followed. 90 teeth with white spot lesions (WSLs) were selected from 30 patients. The participants were randomly assigned into six groups (n=15/group) according to the applied treatment agent (Remin Pro, X Pur Remin, and Pro-fluoride varnish) with diode laser (an average power of 1W, Exposure time of 10 s, diode 810 nm, speed of 1 mm/sec), and Elexxion Perio Green dye or without diode laser
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The first group (A1B1): The teeth with WSLs were treated with Remin Pro with laser application. The second group (A1B2): The contralateral teeth were treated with Remin Pro without laser application.The third group (A2B1): The teeth with WSLs were treated with X Pur Remin with laser application. The fourth group (A2B2): The contralateral teeth were treated with X Pur Remin without laser application. The fifth group (A3B1): The teeth with WSLs were treated with Pro Fluoride Varnish with laser application. The sixth group (A3B2): The contralateral teeth were treated with Pro-Fluoride Varnish without laser.
| Arm | Type | Receives |
|---|---|---|
| fluoride group | Active comparator | Drug: remin proThe first group (A1B1): The teeth with WSLs were treated with fluoride varinsh with laser application. |
| The teeth with WSLs were treated with Remin Pro with laser application | Active comparator | Drug: remin proThe teeth with WSLs were treated with Remin Pro with laser application. The second group (A1B2): The contralateral teeth were treated with Remin Pro without laser application. |
| Xremin pur | Active comparator | Drug: remin proThe teeth with WSLs were treated with Xremin pur with laser application. |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The patients should be 13e40 years old. The patients should have good oral hygiene, general health, and no systemic disease.
Key exclusion criteria (1 listed)
- presence of enamel hypoplasia, dental fluorosis, and carious cavity. These patients have diminished salivary flow or significant tooth wear, and concurrent participation in other clinical trials
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 |
|---|---|---|
| remin proAlso: xpur remineffect of diode laser and perio green dye with reminerlizing agent on surface area white spot lesions by using digital subtraction radiographic technique | Drug | The teeth with WSLs were treated with Remin Pro with laser application, Xremin pur, fluoride group |
Primary outcome
surface area measurement white spot lesion (image anylsis)
Time frame: one month
The I sensor was a USP-driven digital sensor intended to acquire dental intraoral radiograph images. It was combined with the customized poisoning device supplied with the system. One month after the finalization of the remineralization protocol, another radiographic examination was undertaken. Before subtraction, gamma correction was applied to standardize the density and contrast, and images were obtained and saved as Tagged Image File Format (TIFF) and jpg. used image software for each area (Image J software), and follow-up images were subtracted from the base
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remin pro in people with White Spot Lesion of Tooth, run by Al-Azhar University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
surface area measurement white spot lesion (image anylsis) (time frame: one month). 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 14 Sep 2026.