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

ConditionMalocclusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

Qualifiers

Age between 18 and 40 years;

Class I malocclusion

Non-extractive treatment;

No missing teeth (third molars excluded);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Biomax Nuvola aligners
  • Biomax Nuvola aligners

Treatment groups

24 Participants
are divided into 2 treatment groups