Comparing Patient Pain and Comfort with Two Attachment Timing Protocols During Biomax Nuvola Aligner Treatment for Malocclusion

What this Trial Is About

This study focuses on patients with class I and II malocclusion undergoing clear aligner therapy. It aims to compare pain and discomfort levels between two protocols for placing attachments during treatment the conventional protocol where attachments are placed at the first aligner delivery, and a delayed protocol where attachments are placed at the third aligner delivery. The goal is to see if separating these phases, both linked to pain onset, improves patients quality of life during treatment. Pain and discomfort will be assessed using a questionnaire adapted from OHIP-14. Participants will be treated with Biomax Nuvola aligners customized to their dental needs. They will be randomly assigned to either the conventional group with attachments placed at the first aligner or the delayed group with attachments placed at the third aligner, about 30 days into treatment. The aligner is changed every 15 days. Questionnaires measuring oral health impact and attachment discomfort will be completed at six time points 1, 3, and 7 days after the first aligner delivery, and 1, 3, and 7 days after the third aligner delivery. During the study, patients will fill out two questionnaires evaluating functional limitation, pain, psychological discomfort, disability, and social handicap related to aligners and attachments. Responses are scored to reflect quality of life and pain levels. The study is single-blind, with data collectors unaware of group assignments. Researchers will monitor discomfort reduction, timing of pain onset and disappearance, and overall quality of life over one year. Participation involves regular questionnaire completion and use of aligners according to schedule.

Evaluation of the Perceived Experience of Patients Treated With Aligners With Two Different Timings