CTRI

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

White spot lesions (WSLs) are a common complication during fixed orthodontic treatment, affecting approximately 45.8% to 68.4% of patients undergoing orthodontic therapy (Mayma et al., 2023)1. These lesions, characterized by subsurface enamel demineralization, are primarily caused by the accumulation of dental plaque around orthodontic brackets and wires, leading to an increased risk of caries and aesthetic concerns (Tufekci et al., 2011)2.

The irregular surfaces of orthodontic appliances create niches for bacterial colonization, particularly by cariogenic bacteria such as Streptococcus mutans and Lactobacillus acidophilus, which are major contributors to enamel demineralization (Mayma et al., 2023)1. Despite advancements in oral hygiene practices and preventive measures, such as fluoride applications and patient education, the incidence of WSLs remains high, highlighting the need for more effective, non-compliance-dependent solutions.

Chitosan, a natural polysaccharide derived from chitin, has emerged as a promising material in dentistry due to its biocompatibility, biodegradability, and antimicrobial properties (Paradowska-Stolarz et al., 2023)3. Its ability to inhibit bacterial growth, reduce biofilm formation, and promote tissue regeneration makes it an attractive candidate for coating orthodontic appliances. Recent studies have demonstrated that chitosan-coated orthodontic brackets significantly reduce bacterial adhesion and biofilm formation, thereby lowering the risk of WSLs (Mayma et al., 2023)1. Furthermore, chitosan’s antimicrobial activity is attributed to its cationic nature, which disrupts the cell membranes of bacteria, leading to cell death (Paradowska-Stolarz et al., 2023)3.

While the antimicrobial efficacy of chitosan-coated orthodontic brackets has been well-documented, there is limited research on their specific role in reducing the incidence of white spot lesions (WSLs) during fixed orthodontic treatment. White spot lesions are a common complication arising from prolonged plaque accumulation and bacterial colonization around orthodontic appliances. Brackets, in particular, provide surfaces for bacterial adhesion, contributing to the development of these early carious lesions. The application of chitosan coatings on brackets presents a promising strategy to mitigate this risk by leveraging chitosan’s well-established antimicrobial and remineralising properties. However, the long-term effectiveness of chitosan-coated brackets in preventing WSLs, as well as their impact on bacterial load reduction, requires further investigation. This study aims to address this gap through a randomized control trial, comparing quantitative light-induced fluorescence (QLF) values of WSLs before and during treatment at specific time intervals. This study aims to bridge this gap by conducting a comparative evaluation of chitosan-coated orthodontic

brackets in reducing WSLs during fixed orthodontic treatment. By assessing the antimicrobial efficacy, mechanical properties, and clinical performance of chitosan-coated brackets, this research seeks to provide evidence-based recommendations for incorporating chitosan coatings into orthodontic practice The findings of this study could contribute to the development of more effective strategies for preventing WSLs, ultimately improving patient outcomes and reducing the long-term complications associated with fixed orthodontic treatment.

To evaluate the efficacy of chitosan-coated orthodontic brackets in reducing the incidence and severity of WSLs compared to conventional bracket.

The study will be conducted on patients undergoing fixed orthodontic treatment at the Department of Orthodontics and Dentofacial Orthopaedics. A total of 30 patients will be included in the study, with 60 brackets bonded to their first premolars—30 chitosan-coated and 30 conventional. A split-mouth design will be used, where each patient will receive a chitosan-coated bracket on one first premolar and a conventional bracket on the opposite side. The side receiving the chitosan-coated bracket (left or right, maxillary or mandibular) will be randomly assigned using computer-generated allocation, and the opposite side will receive the conventional bracket.

Intervention

•Experimental Group: Chitosan-coated orthodontic brackets.

•Control Group: Standard uncoated orthodontic brackets.

•The chitosan-coated brackets will be obtained from IIT Mumbai.

•All brackets will be bonded using a standardized bonding procedure with light-cure adhesive, followed by the insertion of initial arch wires.

•Prior to treatment, a comprehensive clinical examination and quantitative light-induced fluorescence (QLF) will confirm the absence of pre-existing WSLs.

•All participants will receive oral hygiene instructions, emphasizing the use of fluoride toothpaste and modified bass brushing technique.

Primary Outcome:

Development of white spot lesions assessed using quantitative light-induced fluorescence (QLF) at baseline, 3, 6, and 9 months post-treatment initiation.

QLF is a sensitive method for detecting and quantifying early enamel demineralization, making it suitable for monitoring WSLs adjacent to orthodontic appliances.

Data analysis will compare the incidence and severity of WSLs between the experimental and control groups using appropriate statistical tests, with a significance level set at p < 0.05. Ethical approval will be obtained from the relevant institutional review board, and informed consent will be secured from all participants or their guardians.

This methodology provides a structured approach to assess the potential benefits of chitosan-coated orthodontic appliances in minimizing WSLs during treatment.