White Spot LesionsNCT05562856
Clinical Evaluation of White Spot Lesions Treated by S-PRG Material and Composite Sealants in Comparison With ICON
A study testing surface pre-reacted glass filler coating material in people with White Spot Lesions, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Dental caries is the primary cause of tooth loss and oral diseases. Dental decay is a continuous pathological process with loss of tooth minerals, demineralization, which involves the destruction of tooth structure from acids. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- surface pre-reacted glass filler coating material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2020to 3 Dec 2021
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- 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 Surface Pre-reacted Glass Filler Coating Material and Composite Sealants in Comparison With Icon Resin Infiltration by Using Laser Fluorescence and Spectrophotometer
Dental caries is the primary cause of tooth loss and oral diseases. Dental decay is a continuous pathological process with loss of tooth minerals, demineralization, which involves the destruction of tooth structure from acids. The first sign of early active demineralization is white spot lesions (WSLs) on the tooth surface, meanwhile, subsurface active mineral decomposition.
Read the detailed description
Deposition of minerals depends on the equilibrium between demineralization and remineralization which may happen as a natural repair mechanism. The aim of this trial is to comparatively evaluate the efficacy of surface pre-reacted glass filler (S-PRG) Barrier Coat coating material against the Icon resin infiltration in the ability to improve the caries lesion state of the WSLs along 1 year. Laser fluorescence was used to compare the two materials to evaluate the caries progression. PRG Barrier Coat group showed immediate significant improvement in LF scores in demineralization progress and inhibition of caries progression with a significant improved effect. S-PRG Barrier Coat was clinically successful strategy in inhibition of caries and improve remineralization.
- Conditions
- White Spot Lesions
- Being tested
- surface pre-reacted glass filler coating material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surface pre-reacted glass filler coating materialCombination product
the ability to improve the aesthetic appearance (masking) and caries lesion state of the WSLs
| Study group | Role | What they receive |
|---|---|---|
| surface pre-reacted glass filler coating material | Experimental | surface pre-reacted glass filler coating material used to remineralize WSLs Receives: Combination Product: surface pre-reacted glass filler coating material |
| micro-invasive resin infiltration technique (Icon) | Active comparator | micro-invasive resin infiltration technique (Icon) in the ability to improve caries lesion state (LF scores) and making the WSLs Receives: Combination Product: surface pre-reacted glass filler coating material |
| Permaseal resin | Experimental | Permaseal composite resin sealant as micro-invasive resin infiltration technique in the ability to improve caries lesion state (LF scores) and making the WSLs Receives: Combination Product: surface pre-reacted glass filler coating material |
| Optiguard resin | Experimental | Optiguardcomposite resin sealant as micro-invasive resin infiltration technique in the ability to improve caries lesion state (LF scores) and making the WSLs Receives: Combination Product: surface pre-reacted glass filler coating material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessments of caries lesion state of WSLs:
Assessing of carious lesions state of WSLs, was performed by using Diagnodent pen to record the progression or regression of caries by time. The assessment of the WSLs demineralization condition took place before intervention (baseline) [T0], immediately after intervention [T1], 3 months later [T2] ,6 months later [T3] and 1 year later [T4].
Measured: 1 year
Secondary outcomes (1)
Assessment of color change of WSLs:
The difference in color of the WSLs were performed by Vita Easyshade V at the five distinct times: before intervention (baseline) [T0], immediately after intervention [T1], 3 months later [T2] ,6 months later [T3] and 1 year later [T4].
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 posted3 Oct 2022
- Study start20 Jan 2020
- Primary completion2 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionsStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Gabr, Al-Azhar University
- Investigators
- Khalid Noman, PROF, Study director, Alazhar Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562856
- Sponsor's protocol ID
- 350/466/08/10/19
- Status last verified
- Sep 2022
- First submitted
- 16 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- 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 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of White Spot Lesions Treated by Surface Pre-reacted Glass Filler Coating Material and Composite Sealants in Comparison With Icon Resin Infiltration by Using Laser Fluorescence and Spectrophotometer
- ClinicalTrials.gov ID
- NCT05562856
- Acronym / sponsor ID
- 350/466/08/10/19
- Conditions
- White Spot Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 3 Oct 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.
Dental caries is the primary cause of tooth loss and oral diseases. Dental decay is a continuous pathological process with loss of tooth minerals, demineralization, which involves the destruction of tooth structure from acids. The first sign of early active demineralization is white spot lesions (WSLs) on the tooth surface, meanwhile, subsurface active mineral decomposition.
Detailed description
Deposition of minerals depends on the equilibrium between demineralization and remineralization which may happen as a natural repair mechanism. The aim of this trial is to comparatively evaluate the efficacy of surface pre-reacted glass filler (S-PRG) Barrier Coat coating material against the Icon resin infiltration in the ability to improve the caries lesion state of the WSLs along 1 year. Laser fluorescence was used to compare the two materials to evaluate the caries progression. PRG Barrier Coat group showed immediate significant improvement in LF scores in demineralization progress and inhibition of caries progression with a significant improved effect. S-PRG Barrier Coat was clinically successful strategy in inhibition of caries and improve remineralization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| surface pre-reacted glass filler coating material | Experimental | Combination Product: surface pre-reacted glass filler coating materialsurface pre-reacted glass filler coating material used to remineralize WSLs |
| micro-invasive resin infiltration technique (Icon) | Active comparator | Combination Product: surface pre-reacted glass filler coating materialmicro-invasive resin infiltration technique (Icon) in the ability to improve caries lesion state (LF scores) and making the WSLs |
| Permaseal resin | Experimental | Combination Product: surface pre-reacted glass filler coating materialPermaseal composite resin sealant as micro-invasive resin infiltration technique in the ability to improve caries lesion state (LF scores) and making the WSLs |
| Optiguard resin | Experimental | Combination Product: surface pre-reacted glass filler coating materialOptiguardcomposite resin sealant as micro-invasive resin infiltration technique in the ability to improve caries lesion state (LF scores) and making the WSLs |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| surface pre-reacted glass filler coating materialthe ability to improve the aesthetic appearance (masking) and caries lesion state of the WSLs | Combination product | Optiguard resin, Permaseal resin, micro-invasive resin infiltration technique (Icon), surface pre-reacted glass filler coating material |
Primary outcome
Assessments of caries lesion state of WSLs:
Time frame: 1 year
Assessing of carious lesions state of WSLs, was performed by using Diagnodent pen to record the progression or regression of caries by time. The assessment of the WSLs demineralization condition took place before intervention (baseline) [T0], immediately after intervention [T1], 3 months later [T2] ,6 months later [T3] and 1 year later [T4].
1 secondary outcome
Assessment of color change of WSLs:
Time frame: 1 year
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 4 Oct 2022.
- 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.
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 surface pre-reacted glass filler coating material in people with White Spot Lesions, 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: finished, as of the sponsor's last update on 4 Oct 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?
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?
Assessments of caries lesion state of WSLs: (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 4 Oct 2022.