Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230484
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-01-07
Brief Title:
IFPE Invisalign First Palatal Expander
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
A Prospective Clinical Trial on the Outcomes of Invisalign First Palatal Expander
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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:
Malocclusions with narrow upper arches are usually treated in the mixed dentition with a traditional bonded maxillary expander Most recently a new design of a removable expander by Align was brought to our attention In this prospective clinical study the investigators will compare the patient-reported treatment outcomes and the dental-skeletal treatment effects on palatal dimensions With this study the investigators will have a better understanding of this newly developed appliance and its application in early orthodontic treatment
Detailed Description:
Purpose
This prospective study is aimed to investigate the patient-reported treatment outcomes and the dental-skeletal treatment effects on palatal dimensions and to compare them with those of traditional maxillary expansion
Hypothesis
The null hypothesis will be
1 There are no differences in the inter-canine inter-molar width and molar inclination between IFPE and RME groups
2 There are no differences in the arch width length size and shape palatal surface area and volume plaque index and white spot lesion formation between IFPE and RME groups
3 There are no differences in patients experience of perceived pain intensity and discomfort during the first two weeks of treatment between IFPE and RME groups
Justification
The Invisalign First System IFS has been used in transverse arch development but with less skeletal effects in growing subjects A new appliance Invisalign First palatal expander IFPE designed to rapidly expand the maxillary arch with a daily change protocol has been introduced This prospective clinical trial will compare the efficacy and efficiency between IFPE and conventional rapid maxillary expansion RME for maxillary arch expansion in mixed dentition Patient-reported treatment outcomes in terms of quality of life during the treatment will also be investigated
Objectives
The broad long-term objective of the project is to evaluate the efficacy and efficiency of IFPE and compare the treatment outcomes with those of subjects treated with conventional RME
The specific aim of this research project is to compare the primary the inter-molar width molar inclination the arch width length size and shape palatal surface area and volume and secondary plaque index and white spot lesion formation difficulties with speech and eating outcomes between IFPE and conventional RME for maxillary arch expansion in mixed dentition With the results of this prospective clinical trial orthodontists will gain knowledge of the efficacy and efficiency of IFEP compared with traditional RME and make their own decisions with the evidence to be provided by this study
Research Protocol
Research Design
A power calculation based on the previous study by Lione et al12 indicated a sample of 50 patients in each group to estimate inter-first molar width with a minimum difference of 1mm and a standard deviation SD of 3mm with a power of 80
This project will be a multi-centre prospective clinical trial with two parallel arms The study protocol will be registered on CliniclTrialsgov Ethical approval will be obtained from the Institute Research Board of the University of British Columbia before trial commencement and informed consent will be required from each subject before entering the study
The recruitment will occur at two private orthodontic offices one is an Invisalign diamond providers office and the other is a pediatric dentist and orthodontist group office All the patients who meet the eligibility criteria will be treated with IFPE in the first office While patients recruited from the second office under the same inclusion criteria will be treated with conventional Hyrax-type RME The eligibility criteria will include patients of both sexes from 6 - 12 years of age in mixed dentition with maxillary first molars completely erupted and transverse maxillary deficiency In particular the presence of unilateral or bilateral crossbite or intermolar width as measured where the palatal groove meets the gingival margin of the first molar of 33 mm or less Exclusion criteria will include the following multiple andor advanced caries missing teeth due to aplasia trauma or deep caries supernumerary teeth congenital craniofacial malformations or congenital or acquired systematic disease and previous orthodontic treatment
For each group 50 consecutively recruited patients will be treated with IFPE and RME respectively For the IFPE group patients will be treated with IFPE with no other auxiliaries and no enamel interproximal reduction IPR will be planned during treatment Patients will be instructed to wear the expander 20-22 hoursday with a daily change protocol until the maxillary lingual cusps are in contact with the mandibular buccal cusps followed by passive retention for 6 months In the RME group a two-banded Hyrax-type expander with one-quarter turn 025mm every day will be performed until the maxillary lingual cusps are in contact with the mandibular buccal cusps followed by a passive retention of 6 months Orthodontic appointments will be scheduled weekly at first then moved to monthly
Digital casts before T1 and after expansion T2 will be collected and inter-canine width inter-molar width molar inclination palatal width surface area and volume will be measured by using Rhino3D v50 software Robert McNeel and Associates Seattle Wash The buccal surfaces of the maxillary molars will be assessed for non-cavitated carious lesions white spot lesions using the International Caries Detection and Assessment System ICDAS index The plaque index was assessed using color-based plaque staining Questionnaires will be given to the patients to fill out on days 1 7 and 14 regarding level of pain and discomfort difficulty with speech and eating interference with daily activities and functional jaw impairment
Statistical analysis
SPSS software version 270 IBM Corp Armonk NY will be used for the statistical analyses Measurements for 10 randomly selected models will be repeated 1 week apart to assess intra-examiner agreement Intra-class correlation coefficients and Bland-Altman plots will be used to test the intra-examiner agreement All measurements will be assessed for normality using the Shapiro-Wilks test Descriptive statistics in the form of median and interquartile ranges IQR Q3-Q1 will be reported when the parameters did not show a normal distribution Changes between T1 and T2 in each group will be analyzed with paired t-test for normal data and Wilcoxon signed-rank test for non-normal data Intergroup comparison will be evaluated with t-tests or Mann-Whitney U-tests with Bonferroni correction The significant level was set as P 005
This prospective study is aimed to investigate the patient-reported treatment outcomes and the dental-skeletal treatment effects on palatal dimensions and to compare them with those of traditional maxillary expansion
Hypothesis
The null hypothesis will be
1 There are no differences in the inter-canine inter-molar width and molar inclination between IFPE and RME groups
2 There are no differences in the arch width length size and shape palatal surface area and volume plaque index and white spot lesion formation between IFPE and RME groups
3 There are no differences in patients experience of perceived pain intensity and discomfort during the first two weeks of treatment between IFPE and RME groups
Justification
The Invisalign First System IFS has been used in transverse arch development but with less skeletal effects in growing subjects A new appliance Invisalign First palatal expander IFPE designed to rapidly expand the maxillary arch with a daily change protocol has been introduced This prospective clinical trial will compare the efficacy and efficiency between IFPE and conventional rapid maxillary expansion RME for maxillary arch expansion in mixed dentition Patient-reported treatment outcomes in terms of quality of life during the treatment will also be investigated
Objectives
The broad long-term objective of the project is to evaluate the efficacy and efficiency of IFPE and compare the treatment outcomes with those of subjects treated with conventional RME
The specific aim of this research project is to compare the primary the inter-molar width molar inclination the arch width length size and shape palatal surface area and volume and secondary plaque index and white spot lesion formation difficulties with speech and eating outcomes between IFPE and conventional RME for maxillary arch expansion in mixed dentition With the results of this prospective clinical trial orthodontists will gain knowledge of the efficacy and efficiency of IFEP compared with traditional RME and make their own decisions with the evidence to be provided by this study
Research Protocol
Research Design
A power calculation based on the previous study by Lione et al12 indicated a sample of 50 patients in each group to estimate inter-first molar width with a minimum difference of 1mm and a standard deviation SD of 3mm with a power of 80
This project will be a multi-centre prospective clinical trial with two parallel arms The study protocol will be registered on CliniclTrialsgov Ethical approval will be obtained from the Institute Research Board of the University of British Columbia before trial commencement and informed consent will be required from each subject before entering the study
The recruitment will occur at two private orthodontic offices one is an Invisalign diamond providers office and the other is a pediatric dentist and orthodontist group office All the patients who meet the eligibility criteria will be treated with IFPE in the first office While patients recruited from the second office under the same inclusion criteria will be treated with conventional Hyrax-type RME The eligibility criteria will include patients of both sexes from 6 - 12 years of age in mixed dentition with maxillary first molars completely erupted and transverse maxillary deficiency In particular the presence of unilateral or bilateral crossbite or intermolar width as measured where the palatal groove meets the gingival margin of the first molar of 33 mm or less Exclusion criteria will include the following multiple andor advanced caries missing teeth due to aplasia trauma or deep caries supernumerary teeth congenital craniofacial malformations or congenital or acquired systematic disease and previous orthodontic treatment
For each group 50 consecutively recruited patients will be treated with IFPE and RME respectively For the IFPE group patients will be treated with IFPE with no other auxiliaries and no enamel interproximal reduction IPR will be planned during treatment Patients will be instructed to wear the expander 20-22 hoursday with a daily change protocol until the maxillary lingual cusps are in contact with the mandibular buccal cusps followed by passive retention for 6 months In the RME group a two-banded Hyrax-type expander with one-quarter turn 025mm every day will be performed until the maxillary lingual cusps are in contact with the mandibular buccal cusps followed by a passive retention of 6 months Orthodontic appointments will be scheduled weekly at first then moved to monthly
Digital casts before T1 and after expansion T2 will be collected and inter-canine width inter-molar width molar inclination palatal width surface area and volume will be measured by using Rhino3D v50 software Robert McNeel and Associates Seattle Wash The buccal surfaces of the maxillary molars will be assessed for non-cavitated carious lesions white spot lesions using the International Caries Detection and Assessment System ICDAS index The plaque index was assessed using color-based plaque staining Questionnaires will be given to the patients to fill out on days 1 7 and 14 regarding level of pain and discomfort difficulty with speech and eating interference with daily activities and functional jaw impairment
Statistical analysis
SPSS software version 270 IBM Corp Armonk NY will be used for the statistical analyses Measurements for 10 randomly selected models will be repeated 1 week apart to assess intra-examiner agreement Intra-class correlation coefficients and Bland-Altman plots will be used to test the intra-examiner agreement All measurements will be assessed for normality using the Shapiro-Wilks test Descriptive statistics in the form of median and interquartile ranges IQR Q3-Q1 will be reported when the parameters did not show a normal distribution Changes between T1 and T2 in each group will be analyzed with paired t-test for normal data and Wilcoxon signed-rank test for non-normal data Intergroup comparison will be evaluated with t-tests or Mann-Whitney U-tests with Bonferroni correction The significant level was set as P 005
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