NCT06536335 Evaluation of the Perceived Experience of Patients Treated With Aligners With Two Different Timings
| NCT ID | NCT06536335 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Malocclusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-09-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
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
Contact & Investigator
Massimo Cordaro
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06536335 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Malocclusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06536335 currently recruiting?
Yes, NCT06536335 is actively recruiting participants. Contact the research team at massimo.cordaro@policlinicogemelli.it for enrollment information.
Where is the NCT06536335 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06536335 clinical trial?
NCT06536335 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Massimo Cordaro at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 24 participants.