Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
ID06536335

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-27

24

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study focuses on patients with class I and II malocclusion undergoing clear aligner therapy. It aims to compare pain and discomfort levels between two protocols for placing attachments during treatment: the conventional protocol where attachments are placed at the first aligner delivery, and a delayed protocol where attachments are placed at the third aligner delivery. The goal is to see if separating these phases, both linked to pain onset, improves patients' quality of life during treatment. Pain and discomfort will be assessed using a questionnaire adapted from OHIP-14. Participants will be treated with Biomax Nuvola aligners customized to their dental needs. They will be randomly assigned to either the conventional group with attachments placed at the first aligner or the delayed group with attachments placed at the third aligner, about 30 days into treatment. The aligner is changed every 15 days. Questionnaires measuring oral health impact and attachment discomfort will be completed at six time points: 1, 3, and 7 days after the first aligner delivery, and 1, 3, and 7 days after the third aligner delivery. During the study, patients will fill out two questionnaires evaluating functional limitation, pain, psychological discomfort, disability, and social handicap related to aligners and attachments. Responses are scored to reflect quality of life and pain levels. The study is single-blind, with data collectors unaware of group assignments. Researchers will monitor discomfort reduction, timing of pain onset and disappearance, and overall quality of life over one year. Participation involves regular questionnaire completion and use of aligners according to schedule.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 40 years
  • Class I malocclusion
  • Non-extractive treatment
  • No missing teeth (third molars excluded)
  • Good oral and general health
  • Signed written informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Presence of tooth-related pain, such as dental or periodontal abscesses or gingivitis
  • Presence of semi-included elements
  • Taking bisphosphonates or other anti-resorptive drugs
  • Conditions involving chronic pain or chronic therapy with anti-inflammatory, opioid, or other drugs affecting pain perception
  • Temporomandibular disorders
  • Conditions impairing ability to report sensations of discomfort or pain (e.g., mental retardation, dementia)
  • Refusal to sign written informed consent to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Approximately 3 months or longer depending on treatment plan

Participants begin treatment with Biomax Nuvola aligners customized to their individual needs. Attachments are placed either at the start of the first aligner (conventional protocol) or at the start of the third aligner around 30 days into treatment (delayed protocol).

Visits occur every 15 days to change aligners, with attachment placement timing varying by group

Follow-up

Duration - 7 days after delivery of first and third aligners

Participants complete questionnaires assessing discomfort and quality of life at multiple points: 24 hours, 3 days, and 7 days after the delivery of the first and third aligners.

Questionnaires completed remotely at specified intervals

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC odontoiatria

Roma, Italy, 00168

Actively Recruiting

Loading map...

Research Team

M

Massimo Cordaro

E

Edoardo Staderini

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Prospective, Multicenter, Randomized Clinical Investigatio...

Malocclusion

Actively Recruiting

6 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Pain and Oral-Health-Related Quality of Life in Orthodontic Patients During Initial Therapy with Conventional, Low-Friction, and Lingual Brackets and Aligners (Invisalign): A Prospective Clinical Study.

Laura Antonio-Zancajo, Javier Montero, Alberto Albaladejo...

https://pubmed.ncbi.nlm.nih.gov/32635196

Pain perception among patients treated with passive self-ligating fixed appliances and Invisalign® aligners during the first week of orthodontic treatment.

Naif N Almasoud

https://pubmed.ncbi.nlm.nih.gov/30206531