Status:
WITHDRAWN
Discomfort Perceived by a Cohort of Patients Treated With Aligners and Attachments Placed According to Two Different Protocols
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Malocclusion
Eligibility:
All Genders
18-40 years
Phase:
NA
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), wh...
Detailed Description
The study was approved by the Institutional Review board of the Catholic University of the Sacred Hearth, Rome, Italy (prot. n. 17048/23). All adult patients with class I and II malocclusion referred ...
Eligibility Criteria
Inclusion
- Age between 18 and 40 years;
- Class I and II 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
- 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.
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06218641
Start Date
October 10 2023
End Date
December 22 2024
Last Update
July 18 2024
Active Locations (1)
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1
UOC Odontoiatria Generale e Ortodonzia
Roma, Italy, 00168