White Spot LesionNCT04671134
Evaluation of State and Shade of White Spot Lesions After Using Different Remineralizing Agents (An in Vivo Study)
A study testing Biomimetic remineralizing agent and Resin Modified Glass Ionomer Varnish in people with White Spot Lesion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the effect of Biomimetic remineralizing agent and resin modified glass ionomer varnish on color shade and state of white spot lesions immediately, after 3 months, and after 6 months. (An in vivo study). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Biomimetic remineralizing agent and Resin Modified Glass Ionomer Varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 1 Jun 2019
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients included in this clinical trial were less than 30 years old.
- Patients with good general health.
- Patients who will agree to the consent and will commit to follow-up period.
- Fully erupted anterior teeth with no cavitated lesions.
Who cannot join
- Patients with any systemic disease that may affect normal healing.
- Patient with bad oral hygiene.
- Tetracycline or florosis staining.
- Patients who could/would not participate in all times of follow-up.
- Untreated periodontal disease was not allowed.
- Active caries or defective Restorations in 6 anterior teeth.
Show all 9Show fewer
- Bleaching history
- Patients participating in more than 1 dental study.
- Patient received fluoride varnish before.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the effect of Biomimetic remineralizing agent and resin modified glass ionomer varnish on color shade and state of white spot lesions immediately, after 3 months, and after 6 months. (An in vivo study).
- Conditions
- White Spot Lesion
- Being tested
- Biomimetic remineralizing agent, Resin Modified Glass Ionomer Varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomimetic remineralizing agentOther
Self-assempling peptide
Resin Modified Glass Ionomer VarnishOther
Resin Modified Glass Ionomer Varnish
| Study group | Role | What they receive |
|---|---|---|
| Biomimetic remineralizing agent | Experimental | Not described Receives: Other: Biomimetic remineralizing agent; Other: Resin Modified Glass Ionomer Varnish |
| Resin modified glass ionomer varnish | Active comparator | Not described Receives: Other: Biomimetic remineralizing agent; Other: Resin Modified Glass Ionomer Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
state of lesions
Digital scores
Measured: 6 months.
Secondary outcomes (1)
shade of lesions
Digital scores
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 posted17 Dec 2020
- Study start1 Jun 2017
- Primary completion1 Dec 2018
- Study completion1 Jun 2019
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, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Helmy Elsayed Mohammed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671134
- Sponsor's protocol ID
- 581/3287
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
- Evaluation of State and Shade of White Spot Lesions After Using Different Remineralizing Agents (An in Vivo Study)
- ClinicalTrials.gov ID
- NCT04671134
- Acronym / sponsor ID
- 581/3287
- Conditions
- White Spot Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- 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 aim of the study is to evaluate the effect of Biomimetic remineralizing agent and resin modified glass ionomer varnish on color shade and state of white spot lesions immediately, after 3 months, and after 6 months. (An in vivo study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biomimetic remineralizing agent | Experimental | Other: Biomimetic remineralizing agent, Other: Resin Modified Glass Ionomer Varnish |
| Resin modified glass ionomer varnish | Active comparator | Other: Biomimetic remineralizing agent, Other: Resin Modified Glass Ionomer Varnish |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients included in this clinical trial were less than 30 years old.
- Patients with good general health.
- Patients who will agree to the consent and will commit to follow-up period.
- Fully erupted anterior teeth with no cavitated lesions.
Key exclusion criteria (9 listed)
- Patients with any systemic disease that may affect normal healing.
- Patient with bad oral hygiene.
- Tetracycline or florosis staining.
- Patients who could/would not participate in all times of follow-up.
- Untreated periodontal disease was not allowed.
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 |
|---|---|---|
| Biomimetic remineralizing agentSelf-assempling peptide | Other | Biomimetic remineralizing agent, Resin modified glass ionomer varnish |
| Resin Modified Glass Ionomer VarnishResin Modified Glass Ionomer Varnish | Other | Biomimetic remineralizing agent, Resin modified glass ionomer varnish |
Primary outcome
state of lesions
Time frame: 6 months.
Digital scores
1 secondary outcome
shade of lesions
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 17 Dec 2020.
- Individual participant dataSharing planned: Yes
Related trials for White Spot Lesion
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Bracket Bonding, Orthodontic Treatment
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Not yet recruiting
S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
White Spot Lesion of Tooth, Orthodontic Treatment
Recruiting
Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomimetic remineralizing agent and Resin Modified Glass Ionomer Varnish 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 4 inclusion and 9 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 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 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?
state of lesions (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 17 Dec 2020.