White Spot LesionsPhase 1NCT05948228
Prevention of White Spot Lesions Using Bioactive Gel
A Phase 1 study testing giomer based bioactive gel and Fluoride gel in people with White Spot Lesions, run by Cairo University.
Trial summary
white spot lesions are a common problem and are reported in up to 96% of orthodontic patients. In this study, the preventive effect of bioactive gel is evaluated in comparison to fluoride. Read more about this study
- Who is it for?
- Ages 15 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- giomer based bioactive gel and Fluoride gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Jan 2025
- Phase
- Phase 1
- 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 15 to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients assigned for orthodontic treatment with fixed appliances
- Sound teeth with fixed orthodontic appliances
- Either maxillary or mandibular teeth or both
Who cannot join
- Patients with poor oral hygiene
- Allergic reaction to the materials used.
- Lack of compliance.
- xerostomia
- Evidence of parafunctional habits.
- Active carious lesions
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- Dental fluorosis
- Hypocalcified teeth
- Systemic diseases affecting teeth such as Amelogenesis imperfecta
- Severe periodontal affection
About this study
Official title: Principal Investigator,Resident at Cairo University
white spot lesions are a common problem and are reported in up to 96% of orthodontic patients. In this study, the preventive effect of bioactive gel is evaluated in comparison to fluoride.
Read the detailed description
Dental caries is a chronic infectious disease present worldwide and is among one of the most common oral diseases. It is a multifactorial disease resulting from imbalance between demineralization and remineralization initiated by acid producing bacteria in the microenvironment.
The incipient form of caries, white spot lesions (WSL), is characterized by primitive enamel surface and subsurface demineralization and could be identified clinically by their chalky white appearance . Orthodontic treatment is a major risk factor for the development of WSL. They are reported in up to 96% of orthodontic patients.
Many materials are being used to prevent white spot lesions with fluoride being the most commonly used . New materials have been emerged such as giomer based bioactive gel with the ability to release six ions Fluoride inhibits demineralization and promotes deposition of fluoroapatite. Aluminum helps to decrease demineralization as well by forming Alumino fluoro complexes. Borate reduces biofilm formation beside its antibacterial effect.
Silica promotes remineralization by inducing apatite nucleation on the tooth surface. Strontium converts hydroxyapatite into strontium apatite thus increasing acid resistance and has an inhibitory effect on bacterial growth. Other ions such as Na act as strong base and have acid buffer capacity.
- Conditions
- White Spot Lesions
- Being tested
- giomer based bioactive gel, Fluoride gel
- Keywords
- white spot lesions, orthodontic treatment, Prevention, bioactive gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
giomer based bioactive gelDrug
Application of bioactive gel to prevent white spot lesions in orthodontic patients
Fluoride gelDrug
Application of fluoride gel to prevent white spot lesions in orthodontic patients
| Study group | Role | What they receive |
|---|---|---|
| Application of bioactive gel on teeth in patients assigned for orthodontic treatment | Experimental | Application of bioactive gel on labial/buccal surfaces of teeth is done according to manufacturer instructions using microbrush followed by light curing Receives: Drug: giomer based bioactive gel |
| Application of Fluoride on teeth in patients assigned for orthodontic treatment | Active comparator | Application of fluoride gel will be done using a gel loaded tray held in the mouth for 4 minutes .After removal of tray ,patients must spit out the residual gel. The use of suction is a must to avoid the problem of over ingestion Receives: Drug: Fluoride gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of white spot lesions using DIAGNOdent
the ability of the gels to prevent white spot lesions will be assessed using DIAGNOdent
Measured: Baseline,change from baseline at 3 months,6 months,9 months and 12 months
Secondary outcomes (1)
incidence of white spot lesions using ICDAS (international caries detection and assessment system)
the ability of the gels to prevent white spot lesions will be assessed using ICDAS
Measured: Baseline,change from baseline at 3 months,6 months,9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2025 (estimated)
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 Cairo 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah Khaled El Hindawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948228
- Sponsor's protocol ID
- Giomer based bioactive gel
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 17 Jul 2023
- 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 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator,Resident at Cairo University
- ClinicalTrials.gov ID
- NCT05948228
- Acronym / sponsor ID
- Giomer based bioactive gel
- Conditions
- White Spot Lesions
- Keywords
- white spot lesions, orthodontic treatment, Prevention, bioactive gel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 17 Jul 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.
white spot lesions are a common problem and are reported in up to 96% of orthodontic patients. In this study, the preventive effect of bioactive gel is evaluated in comparison to fluoride.
Detailed description
Dental caries is a chronic infectious disease present worldwide and is among one of the most common oral diseases. It is a multifactorial disease resulting from imbalance between demineralization and remineralization initiated by acid producing bacteria in the microenvironment.
The incipient form of caries, white spot lesions (WSL), is characterized by primitive enamel surface and subsurface demineralization and could be identified clinically by their chalky white appearance . Orthodontic treatment is a major risk factor for the development of WSL. They are reported in up to 96% of orthodontic patients.
Many materials are being used to prevent white spot lesions with fluoride being the most commonly used . New materials have been emerged such as giomer based bioactive gel with the ability to release six ions Fluoride inhibits demineralization and promotes deposition of fluoroapatite. Aluminum helps to decrease demineralization as well by forming Alumino fluoro complexes. Borate reduces biofilm formation beside its antibacterial effect.
Silica promotes remineralization by inducing apatite nucleation on the tooth surface. Strontium converts hydroxyapatite into strontium apatite thus increasing acid resistance and has an inhibitory effect on bacterial growth. Other ions such as Na act as strong base and have acid buffer capacity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application of bioactive gel on teeth in patients assigned for orthodontic treatment | Experimental | Drug: giomer based bioactive gelApplication of bioactive gel on labial/buccal surfaces of teeth is done according to manufacturer instructions using microbrush followed by light curing |
| Application of Fluoride on teeth in patients assigned for orthodontic treatment | Active comparator | Drug: Fluoride gelApplication of fluoride gel will be done using a gel loaded tray held in the mouth for 4 minutes .After removal of tray ,patients must spit out the residual gel. The use of suction is a must to avoid the problem of over ingestion |
Who may qualify
- Ages
- 15 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients assigned for orthodontic treatment with fixed appliances
- Sound teeth with fixed orthodontic appliances
- Either maxillary or mandibular teeth or both
Key exclusion criteria (10 listed)
- Patients with poor oral hygiene
- Allergic reaction to the materials used.
- Lack of compliance.
- xerostomia
- Evidence of parafunctional habits.
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 based bioactive gelApplication of bioactive gel to prevent white spot lesions in orthodontic patients | Drug | Application of bioactive gel on teeth in patients assigned for orthodontic treatment |
| Fluoride gelApplication of fluoride gel to prevent white spot lesions in orthodontic patients | Drug | Application of Fluoride on teeth in patients assigned for orthodontic treatment |
Primary outcome
incidence of white spot lesions using DIAGNOdent
Time frame: Baseline,change from baseline at 3 months,6 months,9 months and 12 months
the ability of the gels to prevent white spot lesions will be assessed using DIAGNOdent
1 secondary outcome
incidence of white spot lesions using ICDAS (international caries detection and assessment system)
Time frame: Baseline,change from baseline at 3 months,6 months,9 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing giomer based bioactive gel and Fluoride gel in people with White Spot Lesions, run by Cairo University.
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 10 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 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
incidence of white spot lesions using DIAGNOdent (time frame: Baseline,change from baseline at 3 months,6 months,9 months and 12 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 Jul 2023.