RecruitingNot ApplicableNCT06536335

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

Evaluation of the Perceived Experience of Patients Treated With Aligners With Two Different Attachment Placement Times: Randomised Controlled Clinical Trial

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

24 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Malocclusion

Summary

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)

Eligibility

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria6

Age between 18 and 40 years;
Class I malocclusion
Non-extractive treatment;
No missing teeth (third molars excluded);
Good oral and general health.
Signature of written informed consent to participate in the study

Exclusion Criteria7

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;
Patients with temporomandibular disorders;
Patients with conditions that may impair the ability to objectively report any sensations of discomfort or pain (e.g., mental retardation, dementia);
Refusal to sign the written informed consent to participate in the study

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Interventions

DEVICEBiomax 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.

DEVICEBiomax Nuvola aligners

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.