The primary aim of the study is to compare the perception of pain and discomfort with two different protocols of attachments' placement during clear aligner therapy: the conventional protocol (CP), when attachments' placement is performed are placed at the delivery of the first aligner; the delayed protocol (DP), when the attachments' placement is performed at the delivery of the third aligner. The rationale of this study is to evaluate whether dividing the two phases most associated with the onset of pain and discomfort, namely the initiation of aligner therapy and the placement of attachments, can improve patients' quality of life during clear aligner treatment. Patients' discomfort will be evaluated with a questionnaire adapted by OHIP-14 (Oral Health Impact Profile 14)
Age between 18 and 40 years;
Class I malocclusion
Non-extractive treatment;
No missing teeth (third molars excluded);
Patients with tooth-related pain (presence of dental and/or periodontal abscesses and presence of gingivitis)
Presence of semi-included elements;
Patients taking bisphosphonates or other anti-resorptive drugs;
Patients with conditions involving chronic pain and/or on chronic therapy with antifiammatories/opiods or other drugs that may act on pain perception;
Parallel
Biomax Nuvola aligners
DeviceAll patients will be treated with Biomax Nuvola aligners built based on the individual patient's characteristics. The number of aligners and the number/type of attachments will be chosen on the basis of the individual malocclusions. In this group the attachments will be bonded at the beginning of first aligner. Two different questionnaires will be administered to the enrolled subjects: the italian version of the adapted OHIP-14 questionnaire, and a customized questionnaire. The questionnaires will be completed at different stages of orthodontic treatment, as following: 24 hours after the delivery of the first aligner - start of orthodontic treatment; 3 days after the start of orthodontic treatment; 7 days after the start of orthodontic treatment; 24 hours after delivery of the third clear aligner; 3 days after delivery of the third clear aligner; 7 days after delivery of the third clear aligner.
Biomax Nuvola aligners
DeviceAll patients will be treated with Biomax Nuvola aligners built based on the individual atient's characteristics. The number of aligners and the number/type of attachments will be chosen on the basis of the individual malocclusions. In this group the attachments will be bonded at the beginning of third aligner, approximately one month after the start of orthodontic treatment. Two different questionnaires will be administered to the enrolled subjects: the italian version of the adapted OHIP-14 questionnaire, and a customized questionnaire. The questionnaires will be completed at different stages of orthodontic treatment, as following: 24 hours after the delivery of the first aligner - start of orthodontic treatment; 3 days after the start of orthodontic treatment; 7 days after the start of orthodontic treatment; 24 hours after delivery of the third clear aligner; 3 days after delivery of the third clear aligner; 7 days after delivery of the third clear aligner.
Evaluation of a possible reduction in discomfort between the two protocols
The primary objective of the study is to evaluate whether splitting the two phases most associated with the onset of pain and discomfort,i.e. the initiation of aligner therapy and the placement of attachments,can reduce these sensations and, consequently,improve adherence to treatment.Specifically,the level of pain symptomatology perceived by the patient will be assessed using the OHIP-14 scale. The OHIP version has 14 questions,concerning the limitation generated by oral health impairment:functional limitation, pain, psychological discomfort, physical disability, psychological disability,social disability, and disability. The possible answers are: never (0), rarely (1), sometimes (2), habitually (3), and very often (4). The score is given by the sum of the values,from a minimum of 0 points to a maximum of 56 points.
Different timing of onset and disappearance of pain
Evaluation of whether the two protocols are associated with different timing of onset and disappearance of pain. In particular, this issue will be evaluated using a questionnaire developed for the study, with questions concerning the presence of discomfort due to aligner treatment and resin composite attachment. This questionnaire has 8 questions and the possible answers are: never(0), rarely(1), sometimes(2), habitually(3), and very often(4). The score is given by the sum of the values from a minimum of 0 points to a maximum of 32.This questionnaire will be sent with different timing, specifically: * 24 hours after the start of orthodontic treatment; * 3 days after the start of orthodontic treatment; * 7 days after the start of orthodontic treatment; * 24 hours after delivery of the third aligner; * 3 days after delivery of the third aligner; * 7 days after delivery of the third aligner.
Impact on patients' quality of life
Evaluate if the two protocols impact patients' quality of life differently. Specifically, the extent of pain symptomatology perceived by the patient will be assessed by the masked operator using the NRS scale (score 0-10, the lower it is, the less pain is perceived by the patient).
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