Initial Dental CariesNCT07111403
Clinical Evaluation of Remineralizing Potential of Remineralizing Agents on WSLs Managment
A study testing SAP fluoride plus, 10% n-HAp. and 10% n-BAG. in people with Initial Dental Caries and White Spot Lesion of Tooth, run by Mansoura University at 1 site in Egypt.
Trial summary
To evaluate and compare the clinical effect of four different remineralizing agents on initial enamel caries after a two years follow up. Read more about this study
- Who is it for?
- Ages 14 to 26 years
- Conditions the study is for
- Initial Dental Caries, White Spot Lesion of Tooth
- What is being tested?
- SAP fluoride plus, 10% n-HAp. and 10% n-BAG.
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2024to 17 Sep 2026
- 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 14 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants should have at least one visible initial enamel caries in the permanent teeth
- Only lesions with ICDAS II score of 1 or 2 could be included
- The patients must have good oral hygiene
Who cannot join
- patients receiving tetracyclines, any other medication known to stain teeth - Patients had fluoride application less than 3 months before the study
- Teeth which have microcavities or dentinal involvement due to loss of enamel - Teeth that have discoloration, enamel hypoplasia or fluorosis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Mansoura University, Egypt
Al Mansurah
Tarek A Arisha, Ass lecturer, 01063912693, tarekadel@mans.edu.eg
About this study
Official title: Remineralization Potential of Different Remineralizing Agents on Initial Enamel Caries: Laboratory Evaluations and Two-year Randomized Clinical Trial
To evaluate and compare the clinical effect of four different remineralizing agents on initial enamel caries after a two years follow up.
Read the detailed description
The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a parallel-arm design.A young- age patients , who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Facultyof Dentistry, University of Mansoura. The study will focus on initial enamel caries on buccal or labial surfaces of permenant teeth.rior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from September 2024 to September 2026. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.Sample size calculation was based on mean NYVAD scores between studied groups retrieved from previous research that most similar to our research using G power program version 3.1.9.7 to calculate sample size based on expected difference of 31% ,using 2-tailed test , α error =0.05 and power = 80.0% , the total calculated sample size will be at least 30 in each group with each patient having at least one active lesion.
- Conditions
- Initial Dental Caries, White Spot Lesion of Tooth
- Being tested
- SAP fluoride plus, 10% n-HAp., 10% n-BAG., Flour Protector S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAP fluoride plusProcedure or surgery
The agent was applied by removing the safety clip, activating the applicator and squeezing out the sponge above the lesion and the solution was left to diffuse for 5 min.the patients were instructed to eat only soft foods and avoid hot liquids for two hours. Also, they were educated and motivated about the importance of oral hygiene.
10% n-HAp.Procedure or surgery
the pastes were applied using micro brushes. The excess was removed after four minutes with a cotton swab. The subjects were advised not to drink or eat for 30 minutes after the treatment. The treatment was applied once every week for a period of four weeks.they instructed to adhere to oral hygiene measures.
10% n-BAG.Procedure or surgery
the pastes were applied using micro brushes. The excess was removed after four minutes with a cotton swab. The subjects were advised not to drink or eat for 30 minutes after the treatment. The treatment was applied once every week for a period of four weeks. patients instructed to adhere to oral hygiene measures.
Flour Protector SProcedure or surgery
After application of varnish, the patient was instructed to avoid abrasive diet for the rest of the day and not brush or floss until the next morning. The treatment was done at baseline and after 6 months.
| Study group | Role | What they receive |
|---|---|---|
| SAP fluoride plus | Active comparator | Participants in this group received P11-4 (Curodont Repair™, Biomedical products for tooth preservation) only at baseline. First, the tooth was completely isolated using rubber dam followed by cleaning of the tooth surface with sodium hypochlorite 2% for 20 s, acid etching with phosphoric acid gel 35-37% for 20 s, rinsing and drying. Receives: Procedure: SAP fluoride plus |
| 10% n-HAp | Active comparator | A Low-speed handpiece was used to clean the tooth surface with fluoride-free pumice (Pumice powder extra fine, SSWhite, Rio de Janeiro, Brazil) after tooth isolation, rinsing, and drying. after that the material was applied Receives: Procedure: 10% n-HAp. |
| 10% n-BAG. | Active comparator | A Low-speed handpiece was used to clean the tooth surface with fluoride-free pumice (Pumice powder extra fine, SSWhite, Rio de Janeiro, Brazil) after tooth isolation, rinsing, and drying. after that the material was applied Receives: Procedure: 10% n-BAG. |
| Flour Protector S | Active comparator | The teeth were dried and a very thin coat of the varnish was applied and allowed to dry for 20 s. Receives: Procedure: Flour Protector S |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICDAS II scores
Remineralization will be assessed using visual tactile assessment of white spot lesions based on change in ICDAS II scores (reduction from score 2 to 1, or from score 1 to 0).
Measured: assessment will be done at baseline and after 3, 6, 12 and 24 months.
Secondary outcomes (1)
DIAGNOdent score
Remineralization will be assessed using The DIAGNOdent score which ranges from 0 to 99 with higher score indicating deeper caries. A decrease in value indicates regression of the carious lesion, whereas an increase indicates progression.
Measured: assessment will be done at baseline and after 3, 6, 12 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start10 Sep 2024
- Primary completion10 Sep 2026 (estimated)
- Study completion17 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Initial Dental 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
- Model description
- Participants in each group received one remineralizing material according to manufacture's instructions or previous studies' recommendations after tooth isolation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarek A Arisha, Ass Lecturer, Principal investigator, Faculty of Dentistry, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111403
- Sponsor's protocol ID
- A0108024CD
- Status last verified
- Sep 2024
- First submitted
- 1 Aug 2025
- Last updated
- 13 Aug 2025
- 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remineralization Potential of Different Remineralizing Agents on Initial Enamel Caries: Laboratory Evaluations and Two-year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07111403
- Acronym / sponsor ID
- A0108024CD
- Conditions
- Initial Dental Caries, White Spot Lesion of Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 17 Sep 2026 (estimated)
- First posted
- 8 Aug 2025 (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.
To evaluate and compare the clinical effect of four different remineralizing agents on initial enamel caries after a two years follow up.
Detailed description
The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a parallel-arm design.A young- age patients , who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Facultyof Dentistry, University of Mansoura. The study will focus on initial enamel caries on buccal or labial surfaces of permenant teeth.rior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from September 2024 to September 2026. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.Sample size calculation was based on mean NYVAD scores between studied groups retrieved from previous research that most similar to our research using G power program version 3.1.9.7 to calculate sample size based on expected difference of 31% ,using 2-tailed test , α error =0.05 and power = 80.0% , the total calculated sample size will be at least 30 in each group with each patient having at least one active lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Participants in each group received one remineralizing material according to manufacture's instructions or previous studies' recommendations after tooth isolation.
| Arm | Type | Receives |
|---|---|---|
| SAP fluoride plus | Active comparator | Procedure: SAP fluoride plusParticipants in this group received P11-4 (Curodont Repair™, Biomedical products for tooth preservation) only at baseline. First, the tooth was completely isolated using rubber dam followed by cleaning of the tooth surface with sodium hypochlorite 2% for 20 s, acid etching with phosphoric acid gel 35-37% for 20 s, rinsing and drying. |
| 10% n-HAp | Active comparator | Procedure: 10% n-HAp.A Low-speed handpiece was used to clean the tooth surface with fluoride-free pumice (Pumice powder extra fine, SSWhite, Rio de Janeiro, Brazil) after tooth isolation, rinsing, and drying. after that the material was applied |
| 10% n-BAG. | Active comparator | Procedure: 10% n-BAG.A Low-speed handpiece was used to clean the tooth surface with fluoride-free pumice (Pumice powder extra fine, SSWhite, Rio de Janeiro, Brazil) after tooth isolation, rinsing, and drying. after that the material was applied |
| Flour Protector S | Active comparator | Procedure: Flour Protector SThe teeth were dried and a very thin coat of the varnish was applied and allowed to dry for 20 s. |
Who may qualify
- Ages
- 14 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Participants should have at least one visible initial enamel caries in the permanent teeth
- Only lesions with ICDAS II score of 1 or 2 could be included
- The patients must have good oral hygiene
Key exclusion criteria (2 listed)
- patients receiving tetracyclines, any other medication known to stain teeth - Patients had fluoride application less than 3 months before the study
- Teeth which have microcavities or dentinal involvement due to loss of enamel - Teeth that have discoloration, enamel hypoplasia or fluorosis.
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 |
|---|---|---|
| SAP fluoride plusThe agent was applied by removing the safety clip, activating the applicator and squeezing out the sponge above the lesion and the solution was left to diffuse for 5 min.the patients were instructed to eat only soft foods and avoid hot liquids for two hours. Also, they were educated and motivated about the importance of oral hygiene. | Procedure or surgery | SAP fluoride plus |
| 10% n-HAp.the pastes were applied using micro brushes. The excess was removed after four minutes with a cotton swab. The subjects were advised not to drink or eat for 30 minutes after the treatment. The treatment was applied once every week for a period of four weeks.they instructed to adhere to oral hygiene measures. | Procedure or surgery | 10% n-HAp |
| 10% n-BAG.the pastes were applied using micro brushes. The excess was removed after four minutes with a cotton swab. The subjects were advised not to drink or eat for 30 minutes after the treatment. The treatment was applied once every week for a period of four weeks. patients instructed to adhere to oral hygiene measures. | Procedure or surgery | 10% n-BAG. |
| Flour Protector SAfter application of varnish, the patient was instructed to avoid abrasive diet for the rest of the day and not brush or floss until the next morning. The treatment was done at baseline and after 6 months. | Procedure or surgery | Flour Protector S |
Primary outcome
ICDAS II scores
Time frame: assessment will be done at baseline and after 3, 6, 12 and 24 months.
Remineralization will be assessed using visual tactile assessment of white spot lesions based on change in ICDAS II scores (reduction from score 2 to 1, or from score 1 to 0).
1 secondary outcome
DIAGNOdent score
Time frame: assessment will be done at baseline and after 3, 6, 12 and 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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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.
Tarek A Arisha, Ass Lecturer principal investigator
Faculty of Dentistry, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAP fluoride plus, 10% n-HAp. and 10% n-BAG. in people with Initial Dental Caries and White Spot Lesion of Tooth, 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 3 inclusion and 2 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 13 Aug 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tarek A Arisha, Ass Lecturer (01063912693, tarekadel@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICDAS II scores (time frame: assessment will be done at baseline and after 3, 6, 12 and 24 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 13 Aug 2025.