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

RecruitingNAAges 18 Years - 40 YearsAllFondazione Policlinico Universitario Agostino Gem…
NCT06536335 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Biomax Nuvola aligners
  • Biomax Nuvola aligners
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Where

1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC odontoiatria
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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