drugset / Trial / NCT05940701

The Effectiveness of Biomimetic Materials in Preventing Enamel Demineralization During Fixed Orthodontic Treatment

NCT05940701 ↗

Unknown 65 enrolled University of Baghdad
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2023-01-15
Primary completion
2023-10-01
Completion
2024-01-01

Outcome

Missed primary endpoint

paper No statistically significant differences were found between groups for ICDAS and GOI. PMID 40657473 ↗

paper Monthly application of Biosmalto Impact Action Mousse™ did not seem to be more effective than fluoridated toothpaste on the development of WSLs after six months. PMID 40657473 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Curasept Biosmalto Mousse Unknown — Topical
Subject Curasept toothpaste Unknown — —