White Spot LesionNCT05550116
Clinical Evaluation of White Spot Lesions Treated by S-PRG and ICON
A study testing Giomer and Two composite resin sealants in people with White Spot Lesion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Randomized with (1:1) prospective, double-blind, controlled trial. Subjects will be randomized to receive S-PRG and the control group receives ICON. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Giomer and Two composite resin sealants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Aug 2021to 11 Oct 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients within 20-40 years of age.
- Each patient has 4 or more WSLs.
- Mild and moderate WSLs according to Gorelick's scale.
- Good oral hygiene and willing patients who can attend the study visits.
- a Symmetrical number of permanent teeth in each arch (mesial to second molars).
Who cannot join
- Active carious lesions.
- Facial surface restorations.
- Intrinsic and extrinsic stains.
- Patients who have a significant medical history or if they smoke.
- Criteria for discontinuation; Mortality and acquiring severe debilitating disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of White Spot Lesions Treated by S-PRG Coating Material and Resin Sealants in Comparison With Resin Infiltration by Using Spectrophotometer and Laser Fluorescence. (A Randomized Controlled Trial) (WSLs)
Randomized with (1:1) prospective, double-blind, controlled trial. Subjects will be randomized to receive S-PRG and the control group receives ICON.
Read the detailed description
Interventions: - All the procedures will be performed by the same clinician. DIAGNOdent will be used to assess the fluorescence loss of WSLs and the adjacent sound enamel. WSLs in permanent teeth will be treated according to the manufacturer's instructions with:
- Group I (Control group): 20 teeth will be treated with ICON.
- Group II ( EXPERIMENTAL) : 20 teeth will be treated with PRG BarrierCoat.
Observation: - The treatment methods will be assessed immediately after the intervention, 3 months,6 months, and one year. The data will be collected for evaluation of the difference in color and fluorescence loss between the treatment groups, by using DIAGNOdent devices, over different time intervals.
Ethical considerations: The research protocol is approved by the ethical committee, Faculty of Dental Medicine, Al-Azhar University and the enrolled patients should sign a written consent form.
- Conditions
- White Spot Lesion
- Being tested
- Giomer, Two composite resin sealants
- Keywords
- white spot lesions, ICON, S-PRG, DIAGNOdent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GiomerOther
Also called PRG Barrier Coat
fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers
Two composite resin sealantsOther
Also called Permaseal and Optiguard
Unfilled composite resin sealants
| Study group | Role | What they receive |
|---|---|---|
| Icon resin infiltration material | Active comparator | Smooth surface resin infiltration comprises three steps for resin infiltration; Icon etch, Icon dry, and Icon infiltrant Receives: Other: Giomer; Other: Two composite resin sealants |
| PRG Barrier Coat | Experimental | fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers Receives: Other: Two composite resin sealants |
| Permaseal composite resin sealant | Experimental | Permaseal unfilled composite resin sealants Receives: Other: Giomer |
| Optiguard | Experimental | Optiguard unfilled composite resin sealant Receives: Other: Giomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients tooth color change
Color change with Vita Easyshade When the Delta E increased, it consider esthetic improving
Measured: 1 year
Secondary outcomes (1)
patients tooth caries lesion state
Laser fluorescence score Assessing of carious lesions state of the lesions by Diagnodent Minimum score is 0, while maximum score is 20 When score is decreased it consider positive results
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start11 Aug 2021
- Primary completion30 Aug 2022
- Study completion11 Oct 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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Wakwak, Al-Azhar University
- Investigators
- Khalid Noman, PROF, Study director, Alazhar Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550116
- Sponsor's protocol ID
- 2286488
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 26 Sep 2022
- 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 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of White Spot Lesions Treated by S-PRG Coating Material and Resin Sealants in Comparison With Resin Infiltration by Using Spectrophotometer and Laser Fluorescence. (A Randomized Controlled Trial) (WSLs)
- ClinicalTrials.gov ID
- NCT05550116
- Acronym / sponsor ID
- 2286488
- Conditions
- White Spot Lesion
- Keywords
- white spot lesions, ICON, S-PRG, DIAGNOdent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 11 Oct 2022 (estimated)
- First posted
- 22 Sep 2022 (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.
Randomized with (1:1) prospective, double-blind, controlled trial. Subjects will be randomized to receive S-PRG and the control group receives ICON.
Detailed description
Interventions: - All the procedures will be performed by the same clinician. DIAGNOdent will be used to assess the fluorescence loss of WSLs and the adjacent sound enamel. WSLs in permanent teeth will be treated according to the manufacturer's instructions with:
- Group I (Control group): 20 teeth will be treated with ICON.
- Group II ( EXPERIMENTAL) : 20 teeth will be treated with PRG BarrierCoat.
Observation: - The treatment methods will be assessed immediately after the intervention, 3 months,6 months, and one year. The data will be collected for evaluation of the difference in color and fluorescence loss between the treatment groups, by using DIAGNOdent devices, over different time intervals.
Ethical considerations: The research protocol is approved by the ethical committee, Faculty of Dental Medicine, Al-Azhar University and the enrolled patients should sign a written consent form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Icon resin infiltration material | Active comparator | Other: Giomer, Other: Two composite resin sealantsSmooth surface resin infiltration comprises three steps for resin infiltration; Icon etch, Icon dry, and Icon infiltrant |
| PRG Barrier Coat | Experimental | Other: Two composite resin sealantsfluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers |
| Permaseal composite resin sealant | Experimental | Other: GiomerPermaseal unfilled composite resin sealants |
| Optiguard | Experimental | Other: GiomerOptiguard unfilled composite resin sealant |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients within 20-40 years of age.
- Each patient has 4 or more WSLs.
- Mild and moderate WSLs according to Gorelick's scale.
- Good oral hygiene and willing patients who can attend the study visits.
- a Symmetrical number of permanent teeth in each arch (mesial to second molars).
Key exclusion criteria (5 listed)
- Active carious lesions.
- Facial surface restorations.
- Intrinsic and extrinsic stains.
- Patients who have a significant medical history or if they smoke.
- Criteria for discontinuation; Mortality and acquiring severe debilitating disease
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 |
|---|---|---|
| GiomerAlso: PRG Barrier Coatfluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers | Other | Icon resin infiltration material, Optiguard, Permaseal composite resin sealant |
| Two composite resin sealantsAlso: Permaseal and OptiguardUnfilled composite resin sealants | Other | Icon resin infiltration material, PRG Barrier Coat |
Primary outcome
patients tooth color change
Time frame: 1 year
Color change with Vita Easyshade When the Delta E increased, it consider esthetic improving
1 secondary outcome
patients tooth caries lesion state
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
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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.
Khalid Noman, PROF study director
Alazhar Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Giomer and Two composite resin sealants in people with White Spot Lesion, 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 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: status not confirmed, as of the sponsor's last update on 26 Sep 2022. 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?
Results are not available in the source record.
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?
patients tooth color change (time frame: 1 year). 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 26 Sep 2022.