Actively Recruiting
Evaluation of the Perceived Experience of Patients Treated With Aligners With Two Different Timings
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-27
24
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of the Perceived Experience of Patients Treated With Aligners With Two Different Timings
Who Can Participate
Eligibility Criteria
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
You will not qualify if you...
- Presence of tooth-related pain such as dental or periodontal abscesses or gingivitis
- Presence of semi-included teeth
- Current use of bisphosphonates or other anti-resorptive drugs
- Conditions involving chronic pain or current therapy with anti-inflammatories, opioids, or other drugs affecting pain perception
- Presence of temporomandibular disorders
- Conditions impairing the ability to reliably report pain or discomfort (e.g., mental retardation, dementia)
- Refusal to sign written informed consent to participate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC odontoiatria
Roma, Italy, 00168
Actively Recruiting
Research Team
M
Massimo Cordaro
CONTACT
E
Edoardo Staderini
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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