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

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

This trial tests whether delaying attachment placement until the third aligner reduces pain and improves quality of life for adults (18–40) receiving Biomax Nuvola clear aligners for malocclusion.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Locations: 1 site (Roma)
• Trial ID: NCT06536335 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–40 with Class I or II malocclusion scheduled for non-extraction Biomax Nuvola aligner treatment who have no missing teeth and are in good general and oral health.

Not a fit: Patients with active dental pain or infections, temporomandibular disorders, chronic pain conditions or on pain-modifying medications, those requiring extractions, or who cannot reliably report symptoms are unlikely to benefit from this protocol change.

Why it matters

Potential benefit: If successful, delaying attachments could reduce early-treatment pain and improve patients' oral-health–related quality of life during the first month of aligner therapy.

How similar studies have performed: Prior orthodontic reports have documented pain peaks after aligner insertion and attachment placement, but formally testing a delayed-attachment protocol is relatively novel with limited prior clinical evidence.

Eligibility criteria

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 this trial is running

Roma

• 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

Conditions: Malocclusion, Attachment, Discomfort, Questionnaires