Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288386
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-15
First Post:
2024-02-18
Brief Title:
Influence of Different Nanohybrid Flowable Composite Resin on Shear Bond Strength and Dimensional Changes of Invisalign Attachments After 6 Months of Brushing
Sponsor:
University of Pavia
Organization:
University of Pavia
Study Overview
Official Title:
Influence of Different Nanohybrid Flowable Composite Resin on Shear Bond Strength and Dimensional Changes of Invisalign Attachments After 6 Months of Brushing in Vitro Study and Randomized Clinical Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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:
The present study will be a single-center split-mouth randomized controlled clinical trial Patients undergoing orthodontic treatment with Invisalign aligners will be enrolled after signing the informed consent Two different flowable composite resins will be evaluated for the performing of attachments using a split-mouth design
group A Filtek Supreme Flow 3M Unitek Monrovia Calif
group B Grandioso Heavy Flow VOCO GmbH Cuxhaven Germany
Digital impressions with iTero intraoral scanner will be performed digital impressions will be performed after 3 months T1 and 6 months T2 from the baseline
Digital scans will be used to assess any changes in shape and volume of the attachments per each different time frame Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software
After attachments placement the clinicians will be asked to answer on a scale from 1 to 10 to this questionnaires questions about the two different flowable composites each question is repeated for each composite resin
Type of brushing with manual or electric toothbrush and hand of brushing will be recorded
group A Filtek Supreme Flow 3M Unitek Monrovia Calif
group B Grandioso Heavy Flow VOCO GmbH Cuxhaven Germany
Digital impressions with iTero intraoral scanner will be performed digital impressions will be performed after 3 months T1 and 6 months T2 from the baseline
Digital scans will be used to assess any changes in shape and volume of the attachments per each different time frame Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software
After attachments placement the clinicians will be asked to answer on a scale from 1 to 10 to this questionnaires questions about the two different flowable composites each question is repeated for each composite resin
Type of brushing with manual or electric toothbrush and hand of brushing will be recorded
Detailed Description:
The present study will be a single-center split-mouth randomized controlled clinical trial Patients willing to start Invisalign treatment or refinement phases will be recruited from the Unit of Orthodontics and Pediatric Dentistry Section of Dentistry Department of Clinical Surgical Diagnostic and Pediatric Sciences University of Pavia Pavia Italy Each patient will sign the informed consent before participation
The bonding procedure will be the following isolation of the working field with the placement of a cheek retractor enamel etching with 37 orthophosphoric acid rinsing and drying application of a thin layer of ScotchBond adhesive 3M Unitek Monrovia Calif and light curing Then patient will be divided into groups A and B in group A attachments will be realized using Filtek Supreme Flow 3M Unitek Monrovia Calif for teeth belonging to mandibular left and maxillary right quadrants whereas in the remaining quadrants they will be realized using Grandioso Heavy Flow VOCO GmbH Cuxhaven Germany In group B quadrants will be inverted After the bonding of the attachments digital impressions with iTero intraoral scanner will be performed digital impressions will be performed after 3 months T1 and 6 months T2 from the baseline
Digital scans will be used to assess any changes in shape and volume of the attachments per each different time frame Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software
After attachments placement the clinicians will be asked to answer on a scale from 1 to 10 to this questionnaires questions about the two different flowable composites each question is repeated for each composite resin
Type of brushing with manual or electric toothbrush and hand of brushing will be recorded
Sample size calculation was performed assuming Type I error alpha005 and Type II error power 80 for two independent study groups and a continuous primary endpoint The primary outcome chosen was Volumetric change Based on the results of previous studies Chen et al 2021 an expected value of 128 was hypothesized The expected difference between the means was supposed to be 044 with a standard deviation of 05 therefore 20 patients were required for the study
The bonding procedure will be the following isolation of the working field with the placement of a cheek retractor enamel etching with 37 orthophosphoric acid rinsing and drying application of a thin layer of ScotchBond adhesive 3M Unitek Monrovia Calif and light curing Then patient will be divided into groups A and B in group A attachments will be realized using Filtek Supreme Flow 3M Unitek Monrovia Calif for teeth belonging to mandibular left and maxillary right quadrants whereas in the remaining quadrants they will be realized using Grandioso Heavy Flow VOCO GmbH Cuxhaven Germany In group B quadrants will be inverted After the bonding of the attachments digital impressions with iTero intraoral scanner will be performed digital impressions will be performed after 3 months T1 and 6 months T2 from the baseline
Digital scans will be used to assess any changes in shape and volume of the attachments per each different time frame Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software
After attachments placement the clinicians will be asked to answer on a scale from 1 to 10 to this questionnaires questions about the two different flowable composites each question is repeated for each composite resin
Type of brushing with manual or electric toothbrush and hand of brushing will be recorded
Sample size calculation was performed assuming Type I error alpha005 and Type II error power 80 for two independent study groups and a continuous primary endpoint The primary outcome chosen was Volumetric change Based on the results of previous studies Chen et al 2021 an expected value of 128 was hypothesized The expected difference between the means was supposed to be 044 with a standard deviation of 05 therefore 20 patients were required for the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None