Enamel CariesNCT05296213
Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents
A study testing Silver diamine fluoride- potassium iodide, Casein phosphopeptide amorphous calcium phosphate and experimental tricalcium silicate in people with Enamel Caries, run by Mansoura University at 1 site in Egypt.
Trial summary
Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Enamel Caries
- What is being tested?
- Silver diamine fluoride- potassium iodide, Casein phosphopeptide amorphous calcium phosphate and experimental tricalcium silicate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 10 Jan 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with early enamel lesions (ICDAS score 1 and 2).
- Patients with normal occlusion .
- Patients must have a good oral hygiene
- patients free from any systemic diseases and don't receive any medication
Who cannot join
- smoker patients
- pregnant females
- patients with bad oral hygiene
- patients with enamel defects ( Amelogenesis Imperfecta, fluorosis, cracks or any developmental defects)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents: 2-years Randomized Clinical Trial
Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents
Read the detailed description
Medical management of incipient lesions by application of remineralizing agents like fluoride therapy, amorphous calcium phosphate (ACP), and Casin phosphopeptide amorphous calcium phosphate (CPP-ACP) has proved to be effective in reversing such lesions.
Fluoride was considered the "gold standard" remineralizing agent , However several recent researchers found that; the ideal remineralizing agents should diffuse or deliver calcium and phosphate ions into early enamel lesion.
Calcium-silicate based material such as β-CaSiO3 and β-Ca2SiO4 play an important role in hard tissue regeneration, showing good bioactivity and biocompatibility and can induce bone like apetite formation in stimulated body fluids. when β-CaSiO3 and β-Ca2SiO4 come in contact with saliva it will be dissolve forming silanol group (Si-O ) on the enamel surface which can bind to Ca ions and inducing the precipitation of hydroxyapatite.
In the light of this, this study was designed to compare the remineralization potential of silver diamine flouride/ potassium iodide, casin phosphopeptide amorphous calcium phosphate and experimental tricalcium silicate on early enamel lesions.
- Conditions
- Enamel Caries
- Being tested
- Silver diamine fluoride- potassium iodide, Casein phosphopeptide amorphous calcium phosphate, experimental tricalcium silicate
- Keywords
- Enamel remineralization, Randomized Clinical Trial, Experimental Tricalcium silicate, Sillver diamine flouride-potassium iodide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver diamine fluoride- potassium iodideDrug
SDF-KI (riva star, SDI.Ltd )was applied ( as a professional application) by micro brush over the early enamel lesions on the buccal surface of molar teeth
Casein phosphopeptide amorphous calcium phosphateDrug
CPP-ACP (tooth mousse, GC, Matraville Sydney, Australia) was applied by using micro brush over the early enamel lesions on the buccal surface of the molar teeth twice daily. the patients were instructed to leave it for about 3minutes before rinsing
experimental tricalcium silicateDrug
prepared tricalcium silicate paste was applied by using micro brush over the early enamel lesions on the buccal surface of the molar teeth twice daily. the patients were instructed to leave it for about 3minutes before rinsing
| Study group | Role | What they receive |
|---|---|---|
| silver diamine fluoride-potassium iodide SDF-KI (riva star) | Experimental | SDF-KI was applied once as a professional application over the early enamel lesions in cervical third of the buccal surface of molar teeth. Receives: Drug: Silver diamine fluoride- potassium iodide |
| casein phosphopeptide amorphous calcium phosphate CPP-ACP(tooth mousse) | Experimental | CPP-ACP cream was applied twice daily according to manufacturer's instructions over the early enamel lesions in cervical third of the buccal surface of molar teeth. Receives: Drug: Casein phosphopeptide amorphous calcium phosphate |
| Experimental tricalcium silicate | Experimental | Experimental tricalcium silicate paste was applied twice daily over the early enamel lesions in cervical third of the buccal surface of molar teeth Receives: Drug: experimental tricalcium silicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents
The primary outcome was the change in laser fluorescence values that was detected by DIAGNODent Pen. The obtained values were interpreted according to the scale provided by the manufacture:
- Value between (0-13) refers to sound enamel substrate
- Value between (14-20) refers to early enamel caries
Measured: 2-years after the first application of the remineralizing agents
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Dec 2019
- Primary completion10 Dec 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel CariesStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296213
- Sponsor's protocol ID
- M03060819
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents: 2-years Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05296213
- Acronym / sponsor ID
- M03060819
- Conditions
- Enamel Caries
- Keywords
- Enamel remineralization, Randomized Clinical Trial, Experimental Tricalcium silicate, Sillver diamine flouride-potassium iodide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 25 Mar 2022 (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.
Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents
Detailed description
Medical management of incipient lesions by application of remineralizing agents like fluoride therapy, amorphous calcium phosphate (ACP), and Casin phosphopeptide amorphous calcium phosphate (CPP-ACP) has proved to be effective in reversing such lesions.
Fluoride was considered the "gold standard" remineralizing agent , However several recent researchers found that; the ideal remineralizing agents should diffuse or deliver calcium and phosphate ions into early enamel lesion.
Calcium-silicate based material such as β-CaSiO3 and β-Ca2SiO4 play an important role in hard tissue regeneration, showing good bioactivity and biocompatibility and can induce bone like apetite formation in stimulated body fluids. when β-CaSiO3 and β-Ca2SiO4 come in contact with saliva it will be dissolve forming silanol group (Si-O ) on the enamel surface which can bind to Ca ions and inducing the precipitation of hydroxyapatite.
In the light of this, this study was designed to compare the remineralization potential of silver diamine flouride/ potassium iodide, casin phosphopeptide amorphous calcium phosphate and experimental tricalcium silicate on early enamel lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| silver diamine fluoride-potassium iodide SDF-KI (riva star) | Experimental | Drug: Silver diamine fluoride- potassium iodideSDF-KI was applied once as a professional application over the early enamel lesions in cervical third of the buccal surface of molar teeth. |
| casein phosphopeptide amorphous calcium phosphate CPP-ACP(tooth mousse) | Experimental | Drug: Casein phosphopeptide amorphous calcium phosphateCPP-ACP cream was applied twice daily according to manufacturer's instructions over the early enamel lesions in cervical third of the buccal surface of molar teeth. |
| Experimental tricalcium silicate | Experimental | Drug: experimental tricalcium silicateExperimental tricalcium silicate paste was applied twice daily over the early enamel lesions in cervical third of the buccal surface of molar teeth |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with early enamel lesions (ICDAS score 1 and 2).
- Patients with normal occlusion .
- Patients must have a good oral hygiene
- patients free from any systemic diseases and don't receive any medication
Key exclusion criteria (4 listed)
- smoker patients
- pregnant females
- patients with bad oral hygiene
- patients with enamel defects ( Amelogenesis Imperfecta, fluorosis, cracks or any developmental defects)
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 |
|---|---|---|
| Silver diamine fluoride- potassium iodideSDF-KI (riva star, SDI.Ltd )was applied ( as a professional application) by micro brush over the early enamel lesions on the buccal surface of molar teeth | Drug | silver diamine fluoride-potassium iodide SDF-KI (riva star) |
| Casein phosphopeptide amorphous calcium phosphateCPP-ACP (tooth mousse, GC, Matraville Sydney, Australia) was applied by using micro brush over the early enamel lesions on the buccal surface of the molar teeth twice daily. the patients were instructed to leave it for about 3minutes before rinsing | Drug | casein phosphopeptide amorphous calcium phosphate CPP-ACP(tooth mousse) |
| experimental tricalcium silicateprepared tricalcium silicate paste was applied by using micro brush over the early enamel lesions on the buccal surface of the molar teeth twice daily. the patients were instructed to leave it for about 3minutes before rinsing | Drug | Experimental tricalcium silicate |
Primary outcome
Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents
Time frame: 2-years after the first application of the remineralizing agents
The primary outcome was the change in laser fluorescence values that was detected by DIAGNODent Pen. The obtained values were interpreted according to the scale provided by the manufacture: * Value between (0-13) refers to sound enamel substrate * Value between (14-20) refers to early enamel caries
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 5 Apr 2022.
- Individual participant dataSharing planned: Yes
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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 Silver diamine fluoride- potassium iodide, Casein phosphopeptide amorphous calcium phosphate and experimental tricalcium silicate in people with Enamel Caries, run by Mansoura 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 5 Apr 2022. 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?
Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents (time frame: 2-years after the first application of the remineralizing agents). 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 5 Apr 2022.