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Discomfort Perceived by a Cohort of Patients Treated With Aligners and Attachments Placed According to Two Different Protocols

NCT06218641 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-07-18

No results posted yet for this study

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).

Conditions

  • Malocclusion

Interventions

DEVICE

CP - conventional protocol

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.

DEVICE

DP - delayed protocol

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 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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2024-04-30
Completion
2024-12-22

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218641 on ClinicalTrials.gov