The Effectiveness of Biomimetic Materials in Preventing Enamel Demineralization During Fixed Appliance Orthodontic Treatment: a Randomized Clinical Trial

763423

This study will be done to evaluate the impact of Biosmalto Impact Action Mousse™ on the development and healing of WSLs in individuals receiving orthodontic treatment. The control group received a fluoridated toothpaste (Colgate toothpaste). The intervention group received Curasept toothpaste and additionally at each visit a Curasept Biosmalto Mousse was applied on the facial surface of the maxillary and mandibular anterior teeth using a tray. For each patient recruited, identical toothbrushes and oral care instructions were given. The patients received instructions to brush their teeth for at least two minutes using an up-down motion on their anterior teeth and a circular motion on their posterior teeth at least three times/day.

2023-01-15

2023-10-01

2024-01-01

Active (not recruiting)

65

Inclusion Criteria: * Willingness to participate. * No underlying medical conditions requiring medications that may cause dryness of the mouth. * Fully erupted permanent maxillary and mandibular canines and incisors that have not been restored. Exclusion Criteria: * Receiving professional fluoridation within the last three months. * Untreated cavitated lesions or significant restorations on the facial surfaces of study teeth. * Labial restoration of any of the study teeth. * Missing any of the study teeth. * Severely rotated any of the study teeth (limiting the appearance of buccal surfaces). * Patients with enamel hypoplasia, dental fluorosis or tetracycline pigmentation. * Dental anomalies related to morphology, anatomy, or development. * Pregnancy and xerostomia. * Heavy smokers. * Craniofacial syndromes such as clefts

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 65, 'type': 'ACTUAL'}}

2023-07-11