Effectiveness and Efficacy of Thermoformed and 3D Printed Aligners in Correcting Malocclusion (Spacing) and Its Impact on Periodontal Oral Health and Oral Microbiome: A Double-Blinded Parallel Randomized Controlled Multicenter Clinical Trial.

Aligners are the common devices used in orthodontics for the correction of malocclusion. Various materials and techniques are employed to fabricate aligners. One of those includes thermoformed and 3D aligners. These aligners can be worn for several days, and their impact on periodontal health is not known. Therefore, the aim of our protocol is to determine the effectiveness of these aligners in correcting malocclusion and their impact on periodontal health and oral microbiome. A double-blinded randomized controlled clinical trial with a total of n = 60 patients will be included with n = 30 in each group (Test: 3D printed aligners and Control: Thermoformed). The evaluation of oral health indices such as basic periodontal examination (BPE), periodontal screening and recording (PSR) that provide the status of periodontal health will be recorded. The oral microbiome assessment will be conducted with polymerase chain reaction (PCR). The primary endpoint will be the correction of malocclusion, and the secondary end point will be the status of periodontal health and oral microbiome. The duration of follow-up for each group will be 7 days for periodontal health and oral microbiome and 6 months for the space closure of 5 mm by 3D and thermoformed aligners.