Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04875104
Status:
UNKNOWN
Last Update Posted:
2021-11-04
First Post:
2021-04-21
Brief Title:
Upper Sequential Distalization With TADs and Aligners
Sponsor:
Universidad Complutense de Madrid
Organization:
Universidad Complutense de Madrid
Study Overview
Official Title:
A Randomized Clinical Trial on Upper Sequential Distalization With Temporary Anchorage Devices TADs and Two Aligner Systems
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the investigators are going to compare the predictability of the backward movement of upper first molars in patients with the upper dentition more advanced than the lower dentition The investigators are going to study if the movements that they predict are achieved and in which proportion and compare it between four different aligner systems The investigators hypothesis is that there are no differences in the predictability of this movement between the four aligner systems
Detailed Description:
In this study the investigators are going to assess and compare the predictability of distal movement of upper molars in patients with class II molar relationship when superimposing the initial malocclusion with the real end of distalization phase and the predicted end of distalization phase Also the investigators are going to study another dental movements pain level aligner properties oral hygiene posterior root resorption patient satisfaction quality of life and efficiency of these systems
The aligner systems that are going to be used are Invisalign System Align Technology San José CA Spark Aligners Ormco Glendora CA Quicksmile Madrid España and ClearCorrect Straumann Austin TX To help achieve the molar movement there is going to be place a TAD temporary anchorage device between two teeth Before starting the study the patients will need some pretreatment records radiographs photographs dental casts and intraoral scan to make a diagnosis and confirm if the patient is suitable for the study
The required sample will be 98 subjects assuming a sample loss of 15 the required sample will be 115 subjects per group Patients will be randomly assigned to either group using a block randomization system and carried out by a researcher not involved in the study Data normality will be examined with the Kolmogorov-Smirnov Descriptive statistics of the different outcomes will be calculated for each group Students paired sample t-test will be used to analyze intragroup differences between T0 and T1 Intergroup comparison among different intervention groups will be performed using multiple analysis of variance MANOVA with Tukeys post-hoc test The investigators will use the Pearson correlation coefficient to evaluate the linear relationship between the mm of distalization achieved and the mm of crowding and between the mm of distalization achieved and the patients age The investigators will perform a binary logistic regression in order to assess the influence of confounding factor clinical variables on the primary outcome All statistical analysis will be conducted using IBM SPSS 240 SPSS Inc Chicago IL USA software with a 005 level of significance
The aligner systems that are going to be used are Invisalign System Align Technology San José CA Spark Aligners Ormco Glendora CA Quicksmile Madrid España and ClearCorrect Straumann Austin TX To help achieve the molar movement there is going to be place a TAD temporary anchorage device between two teeth Before starting the study the patients will need some pretreatment records radiographs photographs dental casts and intraoral scan to make a diagnosis and confirm if the patient is suitable for the study
The required sample will be 98 subjects assuming a sample loss of 15 the required sample will be 115 subjects per group Patients will be randomly assigned to either group using a block randomization system and carried out by a researcher not involved in the study Data normality will be examined with the Kolmogorov-Smirnov Descriptive statistics of the different outcomes will be calculated for each group Students paired sample t-test will be used to analyze intragroup differences between T0 and T1 Intergroup comparison among different intervention groups will be performed using multiple analysis of variance MANOVA with Tukeys post-hoc test The investigators will use the Pearson correlation coefficient to evaluate the linear relationship between the mm of distalization achieved and the mm of crowding and between the mm of distalization achieved and the patients age The investigators will perform a binary logistic regression in order to assess the influence of confounding factor clinical variables on the primary outcome All statistical analysis will be conducted using IBM SPSS 240 SPSS Inc Chicago IL USA software with a 005 level of significance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None