Assessing Biofilm Formation and Bacterial Growth on Orthodontic Appliances

Study Design: This study is designed as a randomized clinical trial to evaluate microbial colonization and clinical performance of different orthodontic archwires. Study Setting and Duration: The study will be conducted at the University of Science and Technology Dental Clinic and a specialized laboratory in Sana’a over the period 2024–2025. Sample Size: A total of 40 participants will be included in the study. The sample size was determined based on power analysis from previously published studies. Participant Allocation and Grouping: Participants will be randomly allocated into four main groups according to the archwire manufacturer. Within each group, participants will be further randomly assigned to receive either stainless steel or nickel-titanium archwires. This randomization process will ensure an equal and unbiased distribution of participants across all study groups. Each participant will be assigned to only one type of archwire material and will not receive both variants at any stage of the study. Intervention Protocol: All participants will be treated using a standardized MBT 0.022-inch fixed orthodontic appliance system. Following baseline assessment and confirmation of good oral hygiene status, the assigned archwire will be placed intraorally and maintained for a period of one month. Participants will receive standardized oral hygiene instructions and will be required to maintain consistent oral care throughout the study period. At the end of the one-month period, the archwires will be carefully removed, and clinical evaluation will be performed, including plaque index assessment. The retrieved archwires will then be subjected to laboratory analysis to identify microbial colonization and evaluate biofilm formation. Inclusion Control: Only participants with good oral hygiene status, defined as a plaque index =1, will be included to minimize variability related to oral environmental factors. Grouping: Participants were allocated into four groups according to the orthodontic archwire brand and type. Group 1: American Orthodontics 0.017" × 0.025" archwires (stainless steel and nickel-titanium variants); Group 2: Aditek 0.017" × 0.025" archwires (stainless steel and nickel-titanium variants); Group 3: MATT 0.017" × 0.025" archwires (stainless steel and nickel-titanium variants); and Group 4: JC Orthodontics 0.019" × 0.025" archwires (stainless steel and nickel-titanium variants). .