Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536335
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Evaluation of the Perceived Experience of Patients Treated With Aligners With Two Different Timings
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Perceived Experience of Patients Treated With Aligners With Two Different Attachment Placement Times Randomised Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALLIN-1
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
Detailed Description:
The study was approved by the Institutional Review board of the Catholic University of the Sacred Hearth Rome Italy prot n 1704823 All adult patients with class I and II malocclusion referred to the Fondazione Policlinico Universitario Agostino Gemelli will be consecutively enrolled for this study All patients will be treated with Biomax Nuvola aligners built based on the individual patients characteristics The number of aligners and the number type of attachments will be chosen on the basis of the individual malocclusions
Patients will be randomly allocated in two different groups the study group includes patients following the delayed protocol DP while the control group is composed of patients following the conventional protocol CP The aligner will be changed every 15 days so the attachment placement in the DP will be performed around 30 days from the beginning of the clear aligner treatment The modified OHIP Italian version has 20 questions categorized into 7 sections concerning the limitation generated by deterioration of oral health in relation to clear aligners functional pain psychological discomfort physical or psychological or social disability and handicap The answers range from 0 never to 4 very often Possible categories are never 0 rarely 1 sometimes 2 habitually 3 and very often 4 Low scores indicate better self-perception of quality of life The customised questionnaire has 9 questions concerning the limitation generated by discomfort caused by attachments For 8 questions the answers range from 0 never to 4 very often Possible categories are never 0 rarely 1 sometimes 2 habitually 3 and very often 4 Low scores indicate better self-perception of quality of life For the last question the answer is based on NRS scale in fact it ranges from 0 to 10 Lower score indicates less pain perceived by the patient The questionnaires will be filled out at different phases of orthodontic treatment specifically at the delivery of the first aligner after 3 and 7 days at the delivery of the third aligner after 3 and 7 days The survey scheduling is arranged according to White who stated that the patients perception of pain and discomfort occurred within 7 days after the beginning of the orthodontic treatment then patients quality of life tends to return to a baseline condition
The study will be single-blind because the person collecting the results and making the assessments will not know which treatment was used In fact the patient will anonymously submit the answers to the questionnaires uploaded on Microsoft Form using an acronym that will be provided to himher by the clinical operator In this way the person collecting and analysing the data will not know to which group the patient who sent the answers belongs
Patients will be randomly allocated in two different groups the study group includes patients following the delayed protocol DP while the control group is composed of patients following the conventional protocol CP The aligner will be changed every 15 days so the attachment placement in the DP will be performed around 30 days from the beginning of the clear aligner treatment The modified OHIP Italian version has 20 questions categorized into 7 sections concerning the limitation generated by deterioration of oral health in relation to clear aligners functional pain psychological discomfort physical or psychological or social disability and handicap The answers range from 0 never to 4 very often Possible categories are never 0 rarely 1 sometimes 2 habitually 3 and very often 4 Low scores indicate better self-perception of quality of life The customised questionnaire has 9 questions concerning the limitation generated by discomfort caused by attachments For 8 questions the answers range from 0 never to 4 very often Possible categories are never 0 rarely 1 sometimes 2 habitually 3 and very often 4 Low scores indicate better self-perception of quality of life For the last question the answer is based on NRS scale in fact it ranges from 0 to 10 Lower score indicates less pain perceived by the patient The questionnaires will be filled out at different phases of orthodontic treatment specifically at the delivery of the first aligner after 3 and 7 days at the delivery of the third aligner after 3 and 7 days The survey scheduling is arranged according to White who stated that the patients perception of pain and discomfort occurred within 7 days after the beginning of the orthodontic treatment then patients quality of life tends to return to a baseline condition
The study will be single-blind because the person collecting the results and making the assessments will not know which treatment was used In fact the patient will anonymously submit the answers to the questionnaires uploaded on Microsoft Form using an acronym that will be provided to himher by the clinical operator In this way the person collecting and analysing the data will not know to which group the patient who sent the answers belongs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None