Clinical Evaluation of Remineralizing Potential of Remineralizing Agents on WSLs Managment

Официальное название

Remineralization Potential of Different Remineralizing Agents on Initial Enamel Caries: Laboratory Evaluations and Two-year Randomized Clinical Trial

Обзор

To evaluate and compare the clinical effect of four different remineralizing agents on initial enamel caries after a two years follow up.

Подробное описание

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.

Вмешательства

• Процедура SAP 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.
• Процедура 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.
• Процедура 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.
• Процедура Flour 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.

Первичные конечные точки

• ICDAS II scores [Срок оценки: assessment will be done at baseline and after 3, 6, 12 and 24 months.]

Вторичные конечные точки (1)

• DIAGNOdent score [Срок оценки: assessment will be done at baseline and after 3, 6, 12 and 24 months.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dentistry, Mansoura University, Egypt — Al Mansurah

Идентификаторы

NCT: NCT07111403 · A0108024CD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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