White Spot Lesion of ToothPhase 3NCT04401280
Bioactive Glass in the Treatment of Enamel White Spot Lesions
A Phase 3 study testing BiominF, Novamin and CPP-ACP in people with White Spot Lesion of Tooth, run by Rania Salah at 1 site in Egypt.
Trial summary
the aim of this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel white spot lesions Read more about this study
- Who is it for?
- Ages 14 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- BiominF, Novamin and CPP-ACP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 30 Jun 2021
- Phase
- Phase 3
- 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 14 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Not less than 1 white spot lesion on the labial surface of teeth in the anterior region with code 2 International Caries Detection and Assessment System II (ICDAS-II) or less
- Absence of any active periodontal disease.
- Written informed consent
Who cannot join
- Known hypersensitivity/allergy to study products and/or materials used
- teeth having deep carious lesions or extensive restorations
- Unwillingness to be randomly assigned to 1 of the 3 treatment groups
- Advanced periodontal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Novel Bioactive Glass in the Treatment of Enamel White Spot Lesions : A Randomized Controlled Trial
the aim of this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel white spot lesions
- Conditions
- White Spot Lesion of Tooth
- Being tested
- BiominF, Novamin, CPP-ACP
- Keywords
- Bioactive glass, CPP-ACP, Remineralization, White spot lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiominFDrug
in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached
NovaminDrug
in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached
CPP-ACPDrug
applied in accordance with the manufacturer's specifications
| Study group | Role | What they receive |
|---|---|---|
| BiominF® | Active comparator | Test group Receives: Drug: BiominF |
| Novamin® | Active comparator | Test group Receives: Drug: Novamin |
| CPP-ACP | Active comparator | Control group Receives: Drug: CPP-ACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in White spot lesions dimension
Quantified using computer-assisted analysis based on digital intraoral photographs
Measured: 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
Secondary outcomes (1)
change in lesion fluorescence
evaluated using diode laser fluorescence device (Diagnodent)
Measured: 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Jun 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot Lesion of ToothStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rania Salah
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary University of London
- Responsible party
- Sponsor-investigator, Rania Salah, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401280
- Sponsor's protocol ID
- WSL treatment
- Status last verified
- Oct 2021
- First submitted
- 15 May 2020
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Novel Bioactive Glass in the Treatment of Enamel White Spot Lesions : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04401280
- Acronym / sponsor ID
- WSL treatment
- Conditions
- White Spot Lesion of Tooth
- Keywords
- Bioactive glass, CPP-ACP, Remineralization, White spot lesions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rania SalahUniversity, hospital or other
- Collaborators
- Queen Mary University of London
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 May 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 this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel white spot lesions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BiominF® | Active comparator | Drug: BiominFTest group |
| Novamin® | Active comparator | Drug: NovaminTest group |
| CPP-ACP | Active comparator | Drug: CPP-ACPControl group |
Who may qualify
- Ages
- 14 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Not less than 1 white spot lesion on the labial surface of teeth in the anterior region with code 2 International Caries Detection and Assessment System II (ICDAS-II) or less
- Absence of any active periodontal disease.
- Written informed consent
Key exclusion criteria (4 listed)
- Known hypersensitivity/allergy to study products and/or materials used
- teeth having deep carious lesions or extensive restorations
- Unwillingness to be randomly assigned to 1 of the 3 treatment groups
- Advanced periodontal 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 |
|---|---|---|
| BiominFin office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached | Drug | BiominF® |
| Novaminin office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached | Drug | Novamin® |
| CPP-ACPapplied in accordance with the manufacturer's specifications | Drug | CPP-ACP |
Primary outcome
Change in White spot lesions dimension
Time frame: 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
Quantified using computer-assisted analysis based on digital intraoral photographs
1 secondary outcome
change in lesion fluorescence
Time frame: 6 months: (Baseline, 1 week, 1 month, 3 months, 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 19 Oct 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BiominF, Novamin and CPP-ACP in people with White Spot Lesion of Tooth, run by Rania Salah 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 4 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 19 Oct 2021. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in White spot lesions dimension (time frame: 6 months: (Baseline, 1 week, 1 month, 3 months, 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 19 Oct 2021.