Patient experience with early versus delayed attachment placement during clear aligner treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults needing non-extraction clear aligner treatment are randomized to either conventional attachment placement at the first aligner or a delayed protocol where attachments are placed at the third aligner; aligners are changed every 15 days. All patients are treated with Biomax Nuvola aligners with the number and type of attachments individualized to the malocclusion. Patient discomfort and oral-health–related quality of life are measured using a modified OHIP-14 questionnaire and a customized 9-question tool focusing on pain, function, and psychosocial effects. The trial recruits adults in good general and oral health and excludes those with active dental infection, temporomandibular disorders, chronic pain conditions, or medications that alter pain perception.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC odontoiatria
  Roma, Italy Recruiting

Study contacts

• Principal investigator: Massimo Cordaro — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Massimo Cordaro
• Email: massimo.cordaro@policlinicogemelli.it
• Phone: +063015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.