Clinical Evaluation of Remineralizing Potential of Remineralizing Agents on WSLs Managment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-26
SponsorMansoura University
About this trial
To evaluate and compare the clinical effect of four different remineralizing agents on initial enamel caries after a two years follow up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
SAP fluoride plus
Procedure/SurgeryThe 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/Surgerythe 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/Surgerythe 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 S
Procedure/SurgeryAfter 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.
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: SAP fluoride plusActive comparator 1 intervention
Group B: 10% n-HApActive comparator 1 intervention
Group C: 10% n-BAG.Active comparator 1 intervention
Group D: Flour Protector SActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
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.
Time frame
assessment will be done at baseline and after 3, 6, 12 and 24 months.Sponsors and contacts
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Source ClinicalTrials.gov