Impact of Dental Composite Viscosity on Attachment Accuracy: a Prospective Clinical Trial

March 12, 2025 updated by: Andrea Scribante, University of Pavia

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. The resulting 3D images will be superimposed onto the reference STL model, representing the pre- planned ideal attachment configuration. Digital scans will be used to assess any changes in shape of the attachments. Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. The resulting 3D images will be superimposed onto the reference STL model, representing the pre-planned ideal attachment configuration. Digital scans will be used to assess any changes in shape of the attachments. Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software. For each of the five attachment surfaces the values obtained for the two composite resins will be compared using three key parameters: total mean discrepancy, mean of positive values only, and mean of negative values only. The analysis will be performed using R software, calculating descriptive statistics for each variable, including mean, standard deviation, median, minimum, and maximum values for each group. The normality of the distributions will be assessed using the Kolmogorov-Smirnov test. Subsequently, a t-test will be applied for inferential analysis of each variable.

For all tests, statistical significance will be set at P<0.05.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients undergoing Invisalign orthodontic treatment

Exclusion Criteria:

  • enamel demineralizations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Higher filler content composite
Attachments will be performed with a higher filler content flowable composite resin.
Device: GrandioSO Heavy Flow
Attachment will be performed with GrandioSO Heavy Flow.
Active Comparator: Lower filler content composite
Attachments will be performed with a lower filler content flowable composite resin.
Device: Filtek Z350XT Flowable
Attachment will be performed with Filtek Z350XT Flowable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the shape of attachments
Time Frame: Baseline
The shape changes of attachments will be evaluated through ZEISS Inspect software.
Baseline
Change in excess of attachments
Time Frame: Baseline
The excess of attachments will be evaluated through ZEISS Inspect software.
Baseline
Change in defect of attachments
Time Frame: Baseline
The defect of attachments will be evaluated through ZEISS Inspect software.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Investigators

  • Principal Investigator: Andrea Scribante, DDS, PhD, University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Actual)

February 10, 2025

Study Completion (Actual)

February 15, 2025

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-ATTACHMENTS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon motivated request to the Principal Investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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