An interventional study of Biomax Nuvola aligners and Biomax Nuvola aligners in Malocclusion, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment
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)
: The study was approved by the Institutional Review board of the Catholic University of the Sacred Hearth, Rome, Italy (prot. n. 17048/23). All adult patients with class I and II malocclusion referred to the Fondazione Policlinico Universitario Agostino Gemelli will be consecutively enrolled for this study. All 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.
Patients will be randomly allocated in two different groups: the study group includes patients following the delayed protocol (DP), while the control group is composed of patients' following the conventional protocol (CP). The aligner will be changed every 15 days, so the attachment placement in the DP will be performed around 30 days from the beginning of the clear aligner treatment. The modified OHIP Italian version has 20 questions categorized into 7 sections, concerning the limitation generated by deterioration of oral health in relation to clear aligners: functional, pain, psychological discomfort, physical or psychological or social disability, and handicap. The answers range from 0 (never) to 4 (very often). Possible categories are: never (0), rarely (1), sometimes (2), habitually (3), and very often (4). Low scores indicate better self-perception of quality of life. The customised questionnaire has 9 questions, concerning the limitation generated by discomfort caused by attachments. For 8 questions, the answers range from 0 (never) to 4 (very often). Possible categories are: never (0), rarely (1), sometimes (2), habitually (3), and very often (4). Low scores indicate better self-perception of quality of life. For the last question the answer is based on NRS scale, in fact it ranges from 0 to 10. Lower score indicates less pain perceived by the patient. The questionnaires will be filled out at different phases of orthodontic treatment, specifically: at the delivery of the first aligner, after 3 and 7 days; at the delivery of the third aligner, after 3 and 7 days. The survey scheduling is arranged according to White, who stated that the patients' perception of pain and discomfort occurred within 7 days after the beginning of the orthodontic treatment; then, patients' quality of life tends to return to a baseline condition.
The study will be single-blind, because the person collecting the results and making the assessments will not know which treatment was used. In fact, the patient will anonymously submit the answers to the questionnaires uploaded on Microsoft Form, using an acronym that will be provided to him/her by the clinical operator. In this way, the person collecting and analysing the data will not know to which group the patient who sent the answers belongs.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 24 is below the median of 37 across 242 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A group of patients a group of patients to whom attachments will be bonded at the beginning of the first aligner.
Device: Biomax Nuvola aligners
A group of patients to whom attachments will be bonded at the beginning of the third aligner, approximately one month after the start of orthodontic treatment.
Device: Biomax Nuvola aligners
All 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.
All 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.
Time frame: 1 year
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.
Time frame: 1 year
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).
Time frame: 1 year
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