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New treatment option for Malocclusion
Official title Evaluation of the Perceived Experience of Patients Treated With Aligners With Two Different Timings
ClinicalTrials.gov ID: NCT06536335
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join if
- Age between 18 and 40 years;
- Class I malocclusion
- Non-extractive treatment;
- No missing teeth (third molars excluded);
- Good oral and general health.
You likely can't join if
- 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);
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.