White Spot Lesion of ToothEarly Phase 1regenerationNCT03930927
Effect of Self Assembling Peptide on White Spot Lesion
A Early Phase 1 study testing Self Assembling peptide and remineralizing agent in people with White Spot Lesion of Tooth, run by Raneen Ahmed.
Trial summary
During re-mineralization of white spot lesion, Will biomimetic self-assembling peptides improve the re-mineralizating effect of the post orthodontic white spot lesion compared to fluoride-based delivery systems? Read more about this study
- Who is it for?
- Ages 12 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- Self Assembling peptide and remineralizing agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 1 Mar 2021
- Phase
- Early 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 12 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with post orthodontic white spot lesion.
- Patients with good oral hygiene.
- Patients with good general health.
- Cooperative patients.
- Subjects who signed the informed consent.
Who cannot join
- Patients with tetracycline pigmentation and dental fluorosis.
- Enamel cavitation.
- Disable patient.
- patient with any systemic disease or severe medical complications.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Re-mineralizing Effect of Biomimetic Self-Assembling Peptides in Post Orthodontic White Spot Lesions Compared to Fluoride-Based Delivery Systems
During re-mineralization of white spot lesion, Will biomimetic self-assembling peptides improve the re-mineralizating effect of the post orthodontic white spot lesion compared to fluoride-based delivery systems?
Read the detailed description
Conservative dentistry no longer prefers the "drill and fill" concept and advocates reversal of lesions via remineralization. . Remineralization is the process of restoring minerals - again, in the form of mineral ions - to the hydroxyapatite latticework structure. It is three-dimensional, and the lost ions must be replaced with ions having the exact same shape, size and the same electrical charge as those lost from the lattice.
Fluoride and self-assembling peptides have been used as adjuncts to enhance remineralization.
- Conditions
- White Spot Lesion of Tooth
- Being tested
- Self Assembling peptide, remineralizing agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Assembling peptideDrug
Also called Curodont
enamel regeneration
remineralizing agentDrug
Also called floride
enamel regeneration
| Study group | Role | What they receive |
|---|---|---|
| Self Assembling peptide | Experimental | intervention Receives: Drug: Self Assembling peptide; Drug: remineralizing agent |
| Fluoride | Experimental | Comparator Receives: Drug: Self Assembling peptide; Drug: remineralizing agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralizing process
using DIAGNOpen.
Measured: 6 months
Secondary outcomes (1)
Visual assessment
using ICDAS II
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 posted29 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raneen Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raneen Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930927
- Sponsor's protocol ID
- 1998
- Acronym
- regeneration
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2019
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- 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 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Re-mineralizing Effect of Biomimetic Self-Assembling Peptides in Post Orthodontic White Spot Lesions Compared to Fluoride-Based Delivery Systems
- ClinicalTrials.gov ID
- NCT03930927
- Acronym / sponsor ID
- regeneration / 1998
- Conditions
- White Spot Lesion of Tooth
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Raneen AhmedUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 29 Apr 2019 (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.
During re-mineralization of white spot lesion, Will biomimetic self-assembling peptides improve the re-mineralizating effect of the post orthodontic white spot lesion compared to fluoride-based delivery systems?
Detailed description
Conservative dentistry no longer prefers the "drill and fill" concept and advocates reversal of lesions via remineralization. . Remineralization is the process of restoring minerals - again, in the form of mineral ions - to the hydroxyapatite latticework structure. It is three-dimensional, and the lost ions must be replaced with ions having the exact same shape, size and the same electrical charge as those lost from the lattice.
Fluoride and self-assembling peptides have been used as adjuncts to enhance remineralization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self Assembling peptide | Experimental | Drug: Self Assembling peptide, Drug: remineralizing agentintervention |
| Fluoride | Experimental | Drug: Self Assembling peptide, Drug: remineralizing agentComparator |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with post orthodontic white spot lesion.
- Patients with good oral hygiene.
- Patients with good general health.
- Cooperative patients.
- Subjects who signed the informed consent.
Key exclusion criteria (4 listed)
- Patients with tetracycline pigmentation and dental fluorosis.
- Enamel cavitation.
- Disable patient.
- patient with any systemic disease or severe medical complications.
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 |
|---|---|---|
| Self Assembling peptideAlso: Curodontenamel regeneration | Drug | Fluoride, Self Assembling peptide |
| remineralizing agentAlso: florideenamel regeneration | Drug | Fluoride, Self Assembling peptide |
Primary outcome
Remineralizing process
Time frame: 6 months
using DIAGNOpen.
1 secondary outcome
Visual assessment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Self Assembling peptide and remineralizing agent in people with White Spot Lesion of Tooth, run by Raneen Ahmed.
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 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: status not confirmed, as of the sponsor's last update on 29 Apr 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact raneen ahmed gohar, Assistant lecturer ((002)01007331552, raneen.aboelgheit@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remineralizing process (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 29 Apr 2019.