White Spot LesionNCT05775250
Evaluation of Two Varnishes on the Improvement of White Spot Lesions in Children
A study testing giomer varnish in people with White Spot Lesion, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
A randomized control trial evaluating the effect of the Giomer varnish versus fluoride varnish on the color improvement of the white spot lesion in permanent anterior teeth of children aged between 8-14 years by using a spectrophotometer at baseline, after 1 month, 3 months and 6 months Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- giomer varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2023to 30 Jan 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Patients with good general health.
- Adequate oral hygiene,
- Patients who didn't receive remineralizing agents during the last 3 months other than regular toothpaste.
Who cannot join
- Uncooperative child.
- Active carious lesion.
- Labial surface restoration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Giomer Varnish Versus Fluoride Varnish on The Color Improvement of White Spot Lesions in Permanent Teeth of Children: A Randomized Controlled Clinical Trial
A randomized control trial evaluating the effect of the Giomer varnish versus fluoride varnish on the color improvement of the white spot lesion in permanent anterior teeth of children aged between 8-14 years by using a spectrophotometer at baseline, after 1 month, 3 months and 6 months
- Conditions
- White Spot Lesion
- Being tested
- giomer varnish
- Keywords
- white spot lesion, fluoride varnish, Giomer Varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
giomer varnishDrug
Giomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once.
| Study group | Role | What they receive |
|---|---|---|
| giomer varnish | Experimental | Giomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once. Receives: Drug: giomer varnish |
| fluoride varnish | Active comparator | 5% NaF fluoride varnish, it will be administrated once. Receives: Drug: giomer varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
white spot lesion color change
assessment of white spot lesion color by using spectrophotometer
Measured: 6 months
Secondary outcomes (1)
Patient response to the treatment
Patient response to the treatment using facial image scale, scores from 1 to 5
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start15 Mar 2023
- Primary completion30 Oct 2023
- Study completion30 Jan 2024
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Ibrahim Ezz, October University for Modern Sciences and Arts
- Investigators
- Naglaa I Ezzeldin, Ass. Prof, Principal investigator, October University for Modern Sciences and arts, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775250
- Sponsor's protocol ID
- REC-D 262-3
- Status last verified
- Apr 2024
- First submitted
- 7 Mar 2023
- Last updated
- 4 Apr 2024
- 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 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Giomer Varnish Versus Fluoride Varnish on The Color Improvement of White Spot Lesions in Permanent Teeth of Children: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05775250
- Acronym / sponsor ID
- REC-D 262-3
- Conditions
- White Spot Lesion
- Keywords
- white spot lesion, fluoride varnish, Giomer Varnish
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 20 Mar 2023 (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.
A randomized control trial evaluating the effect of the Giomer varnish versus fluoride varnish on the color improvement of the white spot lesion in permanent anterior teeth of children aged between 8-14 years by using a spectrophotometer at baseline, after 1 month, 3 months and 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| giomer varnish | Experimental | Drug: giomer varnishGiomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once. |
| fluoride varnish | Active comparator | Drug: giomer varnish5% NaF fluoride varnish, it will be administrated once. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Patients with good general health.
Key exclusion criteria (3 listed)
- Uncooperative child.
- Active carious lesion.
- Labial surface restoration.
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 |
|---|---|---|
| giomer varnishGiomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once. | Drug | fluoride varnish, giomer varnish |
Primary outcome
white spot lesion color change
Time frame: 6 months
assessment of white spot lesion color by using spectrophotometer
1 secondary outcome
Patient response to the treatment
Time frame: 6 months
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 Apr 2024.
- 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.
Naglaa I Ezzeldin, Ass. Prof principal investigator
October University for Modern Sciences and arts, Cairo, Egypt
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 varnish in people with White Spot Lesion, run by October University for Modern Sciences and Arts 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 3 inclusion and 3 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 Apr 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 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?
white spot lesion color change (time frame: 6 months). 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 Apr 2024.