DIAGNOdent pen quantification of the synergy of NovaMin® in fluoride toothpaste to remineralize white spot lesions in patients with fixed orthodontic appliances: A double-blind, randomized, controlled clinical trial

Abstract

Objectives: White spot lesions (WSLs) are a real problem in patients with fixed orthodontic appliances with inadequate hygiene and eating habits. This study aimed at evaluating the synergic effects of NovaMin in fluoride toothpaste on remineralization of WSLs in patients with fixed orthodontic appliances.

Methods: In the present double-blind, randomized, controlled, parallel, clinical trial, Patients with a minimum of 1 WSL on the buccal surface of the anterior teeth and the first premolar on both arches were recruited between 12 February 2021 and 12 April 2021 at the Faculty of Dentistry of X. They were randomly divided into 2 groups, the control group receiving fluoride toothpaste (Sensodyne® Rapid Relief, England), and the study group receiving the fluoride-containing toothpaste and NovaMin (Sensodyne® Repair and Protect, England). A DIAGNOdent pen (KAVO Dental Corporation, Germany) was used to score the WSLs at baseline and then after the usage for 1 and 3months. The primary outcome measures were the difference in DIAGNOdent score in patients with fixed orthodontic appliances that used fluoride toothpaste and NovaMin/fluoride toothpaste. The secondary outcome measures were the intragroup comparison of the DIAGNOdent score in patients with fixed orthodontic appliances that used fluoride toothpaste and NovaMin/fluoride toothpaste. The type of toothpaste used was blinded for the participants, examiner, and data analyser.

Results: A sample size comprising 38 patients (19 patients in each group) was determined. In each group, statistical analysis was conducted on 18 patients. A patient in each group refused to contribute to the study. In both groups (P<0.001), the DIAGNOdent reading of the WSLs decreased significantly after 1 and at 3months, though no significant difference was found between the two groups at different intervals. Each patient had no adverse effects.

Conclusions: In this 3-month follow-up study, NovaMin/fluoride toothpaste provided a slight improvement in WSL remineralisation, but not significant compared to fluoride toothpaste. NovaMin therefore did not have a significant synergistic effect. Both types of toothpaste can improve WSLs in orthodontic patients.

The clinical trial registration number: IRCT20140215016582N5.

Keywords: Fixed orthodontic treatment; NovaMin; Remineralization; White spot lesion.