White Spot Lesion of ToothNCT06402500
Color Masking Potential of Bioactive and ICON Materials
A study testing Icon Infiltrant and Bioactive infiltrant in people with White Spot Lesion of Tooth, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
The non cavitated white-spot lesion (WSL) occurs after sometime during fixed orthodontic treatments, and their treatment is mandatory before going into frank cavitation. The resin infiltration material (ICON, DMG, America) is considered to be the gold standard resin infiltrationmaterial used for WSL treatment. Read more about this study
- Who is it for?
- Ages 12 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- Icon Infiltrant and Bioactive infiltrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteJordan
- Study dates
- 1 Dec 2023to 31 Dec 2024
- 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 12 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria: Patients with teeth and WSL fullfiling the following criteria will be included in the study:
- Anterior and premolar maxillary and mandibular teeth.
- Teeth with no previous restorations.
- post-orthodontic white spot lesions WSL with no adjacent restorations in the same tooth.
- WSL on Labial surfaces of maxillary or mandibular anterior and premolars teeth.
Exclusion Criteria: The following will be excluded from the study,
- Cavitated enamel surface that requires direct composite restorations.
- Presence of developmental enamel defects on the proposed teeth.
- Diabetic patients and patients with metabolic syndrome.
- Pregnant ladies.
- Smoker patients.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of Science and Technology
Irbid, 21110
Zakereyya Albashaireh, PhD, 0791015505, albashai@just.edu.jo
About this study
Official title: The Color Masking Potentials of a Bioactive Glass Adhesive and the Resin ICON on the White Spot Lesions. A Comparative Clinical Trial
The non cavitated white-spot lesion (WSL) occurs after sometime during fixed orthodontic treatments, and their treatment is mandatory before going into frank cavitation. The resin infiltration material (ICON, DMG, America) is considered to be the gold standard resin infiltrationmaterial used for WSL treatment. It is an efficient material in arresting WSLs and has high favorable esthetic recovery. Furthermore, biomaterials like bioactive glass adhesives HI-bond universal adhesive have always been used for replacement, repair and generation of dental hard tissues. The hypotheses of this study are:
- There will be no differences in color masking effect on WSLs managed by bioactive glass adhesive or ICON resin infiltration.
- There will be no significant addition of mineral content into WSLs after treating it with bioactive glass adhesive HI-Bond universal or with ICON.
Read the detailed description
After sample size calculations were carried out a total sample size of 150 teeth will be included (75 teeth will be treated with ICON; and 75 other teeth will be treated with HI-Bond universal].
Split mouth study design involves treating WSLs in two different quadrants in each participant. Treatments will be done according to manufacturer's instruction. The WSLs in the teeth of one quadrant will receive treatments with the ICON (DMG, America) , and the others in the opposite quadrant will receive treatments with the bioactive glass adhesive HI-Bond universal (MEDICLUS, south Korea).
Before receiving the treatment, the WSLs will be tested at baseline by Quantitative light-induced fluorescence (QLF) device then the test will be repeated at 1-month after the treatment for the quadrant that received bioactive glass adhesive.
- Conditions
- White Spot Lesion of Tooth
- Being tested
- Icon Infiltrant, Bioactive infiltrant
- Keywords
- Resin infiltration, Incipient lesion, bioactive material, ICON infiltration resin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icon InfiltrantDrug
Also called ICON (DMG, NJ, US)
White spot lesions are treated with the resin ICON (DMG, NJ, US) for masking their color. The mineral content will be measured in the lesion at baseline and after one month Quantitative light-induced fluorescence QLF.
Bioactive infiltrantDrug
Also called MEDICLUS, Cheongju-si, south Korea
White spot lesions are treated with HI-Bond universal bioactive resin (MEDICLUS, south Korea) for masking their color. Mineral content will be measured in the lesion at baseline and after one month Quantitative light-induced fluorescence QLF.
| Study group | Role | What they receive |
|---|---|---|
| ICON resin group | Experimental | Clean the white spot with prophylactic paste and then infiltrate the lesion with ICON resin. Receives: Drug: Icon Infiltrant |
| Bioactive resin group | Experimental | Clean the white spot with prophylactic paste and then infiltrate the lesion with bioactive resin. Receives: Drug: Bioactive infiltrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color masking potential of ICON material in white spot lesions in permanent teeth.
Photographs will be taken before, immediately after treatment, and 1-month after treatment. These photographs will be used for evaluating of the esthetic outcome by two groups of subjects. The first group comprises the patients themselves. The second group includes dentists. Participants in the evaluation process will will be based on a 100-mm visual analogue scale (VAS). Participants will draw a line on the scale indicating their satisfaction. A line drawn between 0 - 5 cm will mean unsatisfactory outcome while that drawn between 5 - 10 cm will indicate satisfactory outcome.
Measured: 6 months
Color masking potential of HI-Bond universal material in white spot lesions in permanent teeth.
Photographs will be taken before, immediately after treatment, and 1-month after treatment. These photographs will be used for evaluating of the esthetic outcome by two groups of subjects. The first group comprises the patients themselves. The second group includes dentists. Participants in the evaluation process will will be based on a 10-cm visual analogue scale (VAS). Participants will draw a line on the scale indicating their satisfaction. A line drawn between 0 - 5 cm will mean unsatisfactory outcome while that drawn between 5 - 10 cm will indicate satisfactory outcome.
Measured: 6 months
Secondary outcomes (3)
The remineralisation potential of HI-Bond universal material of white spot lesion (WSL) in permanent teeth.
Before receiving the HI-Bond material treatment, the WSL area will be measured by (QLF) device. The fluorescence intensities in the surrounding healthy enamel (baseline); and that in the white spot lesion are computed. The fluorescence loss is the difference of fluorescence intensities between the fluorescence of healthy enamel and that of the WSL.
The same procedure and calculations are repeated after one month of treating the WSL with HI-Bond universal material.
The fluorescence loss (ΔF) is typically reported as percentage (%) of fluorescence loss of that of the surrouding healthy enamel (baseline).
Measured: 3 months
The remineralisation potential of HI-Bond universal material in the deepest point of the white spot lesion (WSL) in permanent teeth.
Before receiving the HI-Bond material treatment, the WSL area will be measured by (QLF) device. Then, the QLF software identifies and quantifies the fluorescence intensity at the area of most significant demineralization within the lesion which is marked by the maximum fluorescence loss within the lesion when compared to that of the surrounding health enamel.
Deepest point in the lesion represents the maximum depth of fluorescence loss within the white spot lesion and is designated the symbol (ΔFMax).
The ΔFMax represents the point within the white spot lesion where the demineralization is most severe, indicating the deepest point of mineral loss.
The same procedure and calculations are repeated after one month of treating the WSL with HI-Bond universal material.
Deepest point in the lesion (ΔFMax) is reported as a percentage (%) of fluorescence loss of that of surrounding healthy enamel (baseline).
Measured: 3 months
The remineralisation potential of HI-Bond universal material on lesion area (pixels) of white spot (WSL) in permanent teeth.
Before receiving the HI-Bond material treatment, the Lesion area of the WSL is manually selected using (QLF) device. Then, the software identifies pixels with reduced fluorescence intensity compared to that of healthy surrounding enamel.
The Lesion area (AΔF) is calculated by summing the total number of demineralized pixels identified within the white spot lesion region. Each pixel represents a unit of area. The area is generally expressed in pixels² (px²) by the software associated with QLF device.
Through the software calibration this value can be converted into mm². The test will be repeated after 1-month of treatment with bioactive glass adhesive.
When reporting the Lesion area (AΔF) in the context of QLF analysis, the unit is in pixels squared (px²).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Dec 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split mouth study design, patients will be assigned to two different treatment protocols.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zakereyya SM Albashaireh, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402500
- Sponsor's protocol ID
- JUST
- Status last verified
- May 2024
- First submitted
- 15 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Color Masking Potentials of a Bioactive Glass Adhesive and the Resin ICON on the White Spot Lesions. A Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT06402500
- Acronym / sponsor ID
- JUST
- Conditions
- White Spot Lesion of Tooth
- Keywords
- Resin infiltration, Incipient lesion, bioactive material, ICON infiltration resin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 May 2024 (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 non cavitated white-spot lesion (WSL) occurs after sometime during fixed orthodontic treatments, and their treatment is mandatory before going into frank cavitation. The resin infiltration material (ICON, DMG, America) is considered to be the gold standard resin infiltrationmaterial used for WSL treatment. It is an efficient material in arresting WSLs and has high favorable esthetic recovery. Furthermore, biomaterials like bioactive glass adhesives HI-bond universal adhesive have always been used for replacement, repair and generation of dental hard tissues. The hypotheses of this study are:
- There will be no differences in color masking effect on WSLs managed by bioactive glass adhesive or ICON resin infiltration.
- There will be no significant addition of mineral content into WSLs after treating it with bioactive glass adhesive HI-Bond universal or with ICON.
Detailed description
After sample size calculations were carried out a total sample size of 150 teeth will be included (75 teeth will be treated with ICON; and 75 other teeth will be treated with HI-Bond universal].
Split mouth study design involves treating WSLs in two different quadrants in each participant. Treatments will be done according to manufacturer's instruction. The WSLs in the teeth of one quadrant will receive treatments with the ICON (DMG, America) , and the others in the opposite quadrant will receive treatments with the bioactive glass adhesive HI-Bond universal (MEDICLUS, south Korea).
Before receiving the treatment, the WSLs will be tested at baseline by Quantitative light-induced fluorescence (QLF) device then the test will be repeated at 1-month after the treatment for the quadrant that received bioactive glass adhesive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth study design, patients will be assigned to two different treatment protocols.
| Arm | Type | Receives |
|---|---|---|
| ICON resin group | Experimental | Drug: Icon InfiltrantClean the white spot with prophylactic paste and then infiltrate the lesion with ICON resin. |
| Bioactive resin group | Experimental | Drug: Bioactive infiltrantClean the white spot with prophylactic paste and then infiltrate the lesion with bioactive resin. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Icon InfiltrantAlso: ICON (DMG, NJ, US)White spot lesions are treated with the resin ICON (DMG, NJ, US) for masking their color. The mineral content will be measured in the lesion at baseline and after one month Quantitative light-induced fluorescence QLF. | Drug | ICON resin group |
| Bioactive infiltrantAlso: MEDICLUS, Cheongju-si, south KoreaWhite spot lesions are treated with HI-Bond universal bioactive resin (MEDICLUS, south Korea) for masking their color. Mineral content will be measured in the lesion at baseline and after one month Quantitative light-induced fluorescence QLF. | Drug | Bioactive resin group |
Primary outcome
Color masking potential of ICON material in white spot lesions in permanent teeth.
Time frame: 6 months
Photographs will be taken before, immediately after treatment, and 1-month after treatment. These photographs will be used for evaluating of the esthetic outcome by two groups of subjects. The first group comprises the patients themselves. The second group includes dentists. Participants in the evaluation process will will be based on a 100-mm visual analogue scale (VAS). Participants will draw a line on the scale indicating their satisfaction. A line drawn between 0 - 5 cm will mean unsatisfactory outcome while that drawn between 5 - 10 cm will indicate satisfactory outcome.
Color masking potential of HI-Bond universal material in white spot lesions in permanent teeth.
Time frame: 6 months
Photographs will be taken before, immediately after treatment, and 1-month after treatment. These photographs will be used for evaluating of the esthetic outcome by two groups of subjects. The first group comprises the patients themselves. The second group includes dentists. Participants in the evaluation process will will be based on a 10-cm visual analogue scale (VAS). Participants will draw a line on the scale indicating their satisfaction. A line drawn between 0 - 5 cm will mean unsatisfactory outcome while that drawn between 5 - 10 cm will indicate satisfactory outcome.
3 secondary outcomes
The remineralisation potential of HI-Bond universal material of white spot lesion (WSL) in permanent teeth.
Time frame: 3 months
The remineralisation potential of HI-Bond universal material in the deepest point of the white spot lesion (WSL) in permanent teeth.
Time frame: 3 months
The remineralisation potential of HI-Bond universal material on lesion area (pixels) of white spot (WSL) in permanent teeth.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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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.
Zakereyya SM Albashaireh, PhD principal investigator
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 Icon Infiltrant and Bioactive infiltrant in people with White Spot Lesion of Tooth, run by King Abdullah University Hospital 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?
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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zakereyya SM Albashaireh, Ph.D (0096227201000 ext. 23573, albashai@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color masking potential of ICON material in white spot lesions in permanent teeth. (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 7 May 2024.