White Spot LesionNCT05001035
Effect of Different Biomimetic Materials on White Spot Lesions in Enamel
A study testing Time of assessment in people with White Spot Lesion, run by Benha University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate: 1- The remineralizing effect of different biomimetic materials (Zinc carbonate hydroxyapatite nanoparticles, Poly-amido amine (PAMAM) and bioactive glass nanoparticles) on white spot lesions in enamel. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Time of assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 20 Sep 2021
- 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Total of 21 patients enrolled in this study will be selected having at least 4 teeth (one on each quadrant) which will be extracted for orthodontic treatment.
- These patients will be selected according to age groups between 15-25 years old
- good oral hygiene
- free of destroying habits for dental tissues
Who cannot join
- Bruxism
- soft drinks consumption
- acid regurgitation, etc.).
- Selected teeth having any cracks, malformations, dysplasia or caries.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dental medicine for girls branch of Alazhar University
Cairo
About this study
This study will be conducted to evaluate: 1- The remineralizing effect of different biomimetic materials (Zinc carbonate hydroxyapatite nanoparticles, Poly-amido amine (PAMAM) and bioactive glass nanoparticles) on white spot lesions in enamel. 2- The clinical efficacy of these agents on disappearance of these white spots.
- Conditions
- White Spot Lesion
- Being tested
- Time of assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time of assessmentOther
Immediate and after one month and after two months
| Study group | Role | What they receive |
|---|---|---|
| Zinc carbonated hydroxy apatite | Experimental | Toothpaste to be added on white spot lesions in dental enamel Receives: Other: Time of assessment |
| Bioactive glass | Experimental | Toothpaste to be added on white spot lesions in dental enamel Receives: Other: Time of assessment |
| Poly amido amine | Experimental | Resinous material to be painted on white spot lesions in dental enamel Receives: Other: Time of assessment |
| Control | No intervention | No material to be added |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in remineralization from base line to time limit
Change in its density in digital xray
Measured: Immediate and one month and two months
changes of appearance from base line photograph to time limit
White spots disappear on digital photography
Measured: Immediate and one month and two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Jul 2021
- Primary completion18 Sep 2021
- Study completion20 Sep 2021
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 Benha 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
- Crossover
- Model description
- Split mouth technique
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eptesam Atef, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001035
- Sponsor's protocol ID
- OP-P-018-001
- Other IDs
- OPDEN-107-1-G
- Status last verified
- Oct 2021
- First submitted
- 28 Jul 2021
- Last updated
- 7 Oct 2021
- 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 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Biomimetic Materials on White Spot Lesions in Enamel
- ClinicalTrials.gov ID
- NCT05001035
- Acronym / sponsor ID
- OP-P-018-001
- Conditions
- White Spot Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 18 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 11 Aug 2021 (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.
This study will be conducted to evaluate: 1- The remineralizing effect of different biomimetic materials (Zinc carbonate hydroxyapatite nanoparticles, Poly-amido amine (PAMAM) and bioactive glass nanoparticles) on white spot lesions in enamel. 2- The clinical efficacy of these agents on disappearance of these white spots.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Split mouth technique
| Arm | Type | Receives |
|---|---|---|
| Zinc carbonated hydroxy apatite | Experimental | Other: Time of assessmentToothpaste to be added on white spot lesions in dental enamel |
| Bioactive glass | Experimental | Other: Time of assessmentToothpaste to be added on white spot lesions in dental enamel |
| Poly amido amine | Experimental | Other: Time of assessmentResinous material to be painted on white spot lesions in dental enamel |
| Control | No intervention | –No material to be added |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Total of 21 patients enrolled in this study will be selected having at least 4 teeth (one on each quadrant) which will be extracted for orthodontic treatment.
- These patients will be selected according to age groups between 15-25 years old
- good oral hygiene
- free of destroying habits for dental tissues
Key exclusion criteria (4 listed)
- Bruxism
- soft drinks consumption
- acid regurgitation, etc.).
- Selected teeth having any cracks, malformations, dysplasia or caries.
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 |
|---|---|---|
| Time of assessmentImmediate and after one month and after two months | Other | Bioactive glass, Poly amido amine, Zinc carbonated hydroxy apatite |
Primary outcome
change in remineralization from base line to time limit
Time frame: Immediate and one month and two months
Change in its density in digital xray
changes of appearance from base line photograph to time limit
Time frame: Immediate and one month and two months
White spots disappear on digital photography
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 7 Oct 2021.
- 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.
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 Time of assessment in people with White Spot Lesion, run by Benha 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 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 7 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.
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 remineralization from base line to time limit (time frame: Immediate and one month and two months). The study lists 2 primary outcomes in all. 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 7 Oct 2021.