White Spot LesionNCT04673097
Performance of Different Resin Infiltration Materials on White Spot Lesions: Clinical and Laboratory Assessments
A study testing Icon® resin infiltration and MI paste plus in people with White Spot Lesion, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
The study is a clinical controlled trial. Ethical approval will be obtained from Imam Abdulrahman bin Faisal University, Dammam. The study participants will be recruited from the dental hospital and conducted between November 2020 to November 2020. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Icon® resin infiltration and MI paste plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 19 Dec 2020to 30 Nov 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who are willing and able to observe good oral hygiene and attend for the study visits.
- Subjects with ≥1 visible and accessible early caries lesion present.
- No prior white spot lesion treatment utilized except tooth brushing with fluoridated toothpaste.
Who cannot join
- Active carious lesions
- Facial surface restorations
- Deciduous teeth
- Enamel alteration (fluorosis, opacity, hypocalcification, hypoplasia)
- Intrinsic and extrinsic strains
- Physically and mentally challenged volunteers
- Patients with systemic diseases under medication
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
The study is a clinical controlled trial. Ethical approval will be obtained from Imam Abdulrahman bin Faisal University, Dammam. The study participants will be recruited from the dental hospital and conducted between November 2020 to November 2020. This will be a single-center, randomized, single blinded with a 1:1:1 allocation ratio for the application of Icon® resin infiltration, MI Paste Plus and both treatments
- Conditions
- White Spot Lesion
- Being tested
- Icon® resin infiltration, MI paste plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icon® resin infiltrationOther
low viscosity resin that can flow through the pores in the enamel surface
MI paste plusOther
s a superior form of fluoride ions as it also contains CPP-ACP, enhances mineral release without encouraging the formation of calculus.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Other: Icon® resin infiltration |
| Group 2 | Active comparator | Not described Receives: Other: MI paste plus |
| Group 3 | Active comparator | Not described Receives: Other: Icon® resin infiltration; Other: MI paste plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color improvements
Pre-treatment and post-treatment color changing (L*A*B values) of digital photographs using the Commission Internationale de l'Eclairage (CIE) system
Measured: Change from 0 day, 1 month and 6 months
Patient self satisfaction
Post-treatment patient satisfaction using the patient satisfaction scale
Measured: Change from 0 day, 1 month and 6 months
Change in lesion status
Post-treatment change in caries lesion status using ICDAS II
Measured: Change from 0 day, 1 month and 6 months
Cracks of enamel.
Number of cracks assessed by enamel surface analysis via silicone replicas using CLSM
Measured: Change from 0 day, 1 month and 6 months
Microbial composition.
Pre-treatment and post-treatment microbial composition of plaque samples. Samples will be stored at -80 °C until DNA extractions will be performed and run the 16S rRNA sequencing.
Measured: Change from 0 day, 1 month and 6 months
Effects on clinical parameter: sensitivity to percussion
Pre-treatment and post-treatment effects on sensitivity to percussion by end blunted instrument.
Measured: Change from 0 day, 1 month and 6 months
esthetic improvement
Esthetic improvement through objective assessments using a visual analogue
Measured: Change from 0 day, 1 month and 6 months
Patient esthetic self perception
Pre-treatment esthetic self perception by the subjects using questionnaire
Measured: Change from 0 day, 1 month and 6 months
change in lesion size
Pre-treatment and post-treatment white spot lesion size
Measured: Change from 0 day, 1 month and 6 months
fracture of enamel.
Number of fracture assessed by enamel surface analysis via silicone replicas using CLSM
Measured: Change from 0 day, 1 month and 6 months
Effects on clinical parameter: prolonged response to hot or cold.
Pre-treatment and post-treatment effects on response to hot or cold by cold test
Measured: Change from 0 day, 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start19 Dec 2020 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jumanah Aljishi, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673097
- Sponsor's protocol ID
- IAU_resin
- Status last verified
- Dec 2020
- First submitted
- 10 Oct 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Different Resin Infiltration Materials on White Spot Lesions: Clinical and Laboratory Assessments
- ClinicalTrials.gov ID
- NCT04673097
- Acronym / sponsor ID
- IAU_resin
- Conditions
- White Spot Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 19 Dec 2020 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 17 Dec 2020 (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 study is a clinical controlled trial. Ethical approval will be obtained from Imam Abdulrahman bin Faisal University, Dammam. The study participants will be recruited from the dental hospital and conducted between November 2020 to November 2020. This will be a single-center, randomized, single blinded with a 1:1:1 allocation ratio for the application of Icon® resin infiltration, MI Paste Plus and both treatments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Icon® resin infiltration |
| Group 2 | Active comparator | Other: MI paste plus |
| Group 3 | Active comparator | Other: Icon® resin infiltration, Other: MI paste plus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are willing and able to observe good oral hygiene and attend for the study visits.
- Subjects with ≥1 visible and accessible early caries lesion present.
- No prior white spot lesion treatment utilized except tooth brushing with fluoridated toothpaste.
Key exclusion criteria (8 listed)
- Active carious lesions
- Facial surface restorations
- Deciduous teeth
- Enamel alteration (fluorosis, opacity, hypocalcification, hypoplasia)
- Intrinsic and extrinsic strains
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® resin infiltrationlow viscosity resin that can flow through the pores in the enamel surface | Other | Group 1, Group 3 |
| MI paste pluss a superior form of fluoride ions as it also contains CPP-ACP, enhances mineral release without encouraging the formation of calculus. | Other | Group 2, Group 3 |
Primary outcome
Color improvements
Time frame: Change from 0 day, 1 month and 6 months
Pre-treatment and post-treatment color changing (L*A*B values) of digital photographs using the Commission Internationale de l'Eclairage (CIE) system
Patient self satisfaction
Time frame: Change from 0 day, 1 month and 6 months
Post-treatment patient satisfaction using the patient satisfaction scale
Change in lesion status
Time frame: Change from 0 day, 1 month and 6 months
Post-treatment change in caries lesion status using ICDAS II
Cracks of enamel.
Time frame: Change from 0 day, 1 month and 6 months
Number of cracks assessed by enamel surface analysis via silicone replicas using CLSM
Microbial composition.
Time frame: Change from 0 day, 1 month and 6 months
Pre-treatment and post-treatment microbial composition of plaque samples. Samples will be stored at -80 °C until DNA extractions will be performed and run the 16S rRNA sequencing.
Effects on clinical parameter: sensitivity to percussion
Time frame: Change from 0 day, 1 month and 6 months
Pre-treatment and post-treatment effects on sensitivity to percussion by end blunted instrument.
esthetic improvement
Time frame: Change from 0 day, 1 month and 6 months
Esthetic improvement through objective assessments using a visual analogue
Patient esthetic self perception
Time frame: Change from 0 day, 1 month and 6 months
Pre-treatment esthetic self perception by the subjects using questionnaire
change in lesion size
Time frame: Change from 0 day, 1 month and 6 months
Pre-treatment and post-treatment white spot lesion size
fracture of enamel.
Time frame: Change from 0 day, 1 month and 6 months
Number of fracture assessed by enamel surface analysis via silicone replicas using CLSM
Effects on clinical parameter: prolonged response to hot or cold.
Time frame: Change from 0 day, 1 month and 6 months
Pre-treatment and post-treatment effects on response to hot or cold by cold test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
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® resin infiltration and MI paste plus in people with White Spot Lesion, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Dec 2020. 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 Saudi Arabia. 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 jumanah aljishi (00966534282332, jumanah.aljishi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color improvements (time frame: Change from 0 day, 1 month and 6 months). The study lists 11 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 17 Dec 2020.