Initial Dental Caries, White Spot Lesion of Tooth
Conditions
Brief summary
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.
Interventions
PROCEDURESAP fluoride plus
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.
PROCEDURE10% 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.
PROCEDURE10% 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.
PROCEDUREFlour Protector S
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.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator) Double (Participant, Investigator)
Intervention model description
Participants in each group received one remineralizing material according to manufacture's instructions or previous studies' recommendations after tooth isolation.
Eligibility
Sex/Gender
ALL
Age
14 Years to 26 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICDAS II scores | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DIAGNOdent score | assessment will be done at baseline and after 3, 6, 12 and 24 months. | 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. |
Countries
Egypt
Contacts
Primary ContactTarek A Arisha, Ass Lecturer
Outcome results
None listed