A Novel Oral Bioadhesive Formulation Incorporated with NanoHydroxyapatite and Acorus Calamus Rhizome Extract to Prevent White Spot Lesion – A Randomized Controlled Trial

Background A significant drawback during and after fixed orthodontic treatment (FT) is the white spot lesion (WL), which is an increased demineralization of the enamel.Aim The current study developed a sustain-release oral bio-adhesive formulation (OBAF) to treat WL. This formulation contains nanohydroxyapatite and or Acorus calamus rhizome extract.Methodology The research involved an in-vitro and in-vivo phase of a study on the effectiveness of a new orthodontic treatment, OBAF, in fixing WL on intentionally created WL on extracted premolars. The study involved 20 extracted premolar teeth divided into four groups, with three experimental and one control. In the in-vivo phase, 40 individuals aged 18–25 were randomized to a clinical trial, assessing the effectiveness of the treatment drugs. The study involved 10 participants in a split group assessing the effectiveness of therapy drugs for WL through biochemical and photographic assessments. After processing, the data was statistically examined.Result In both in-vitro and in-vivo investigations, Group A (oral bio-adhesive formulation with nanohydroxyapatite) showed excellent remineralization characteristics, followed by Group C (oral bio-adhesive formulation with nanohydroxyapatite and Acorus calamus rhizome extract).Conclusion OBAF with nanohydroxyapatite, either alone or in combination with Acorus calamus rhizome extract, showed exceptional enamel remineralization properties. Therefore, either during or after FT, this OBAF can be utilized to manage WL.Registration Clinical Trial Registry of India (CTRI) registration number is CTRI/2022/07/043628. It is registered nationally in India.