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

NCT06288386 | Completed

• 1 other identifier: 2024-ATTACHMENTS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (3)

• Changes in the shape of attachments

  The shape changes of attachments will be evaluated through ZEISS Inspect software.

  Baseline

• Change in excess of attachments

  The excess of attachments will be evaluated through ZEISS Inspect software.

  Baseline

• Change in defect of attachments

  The defect of attachments will be evaluated through ZEISS Inspect software.

  Baseline

Study Arms (2)

Higher filler content composite

EXPERIMENTAL

Attachments will be performed with a higher filler content flowable composite resin.

Device: GrandioSO Heavy Flow

Lower filler content composite

ACTIVE COMPARATOR

Attachments will be performed with a lower filler content flowable composite resin.

Device: Filtek Z350XT Flowable

Interventions

GrandioSO Heavy Flow DEVICE

Attachment will be performed with GrandioSO Heavy Flow.

Higher filler content composite

Filtek Z350XT Flowable DEVICE

Attachment will be performed with Filtek Z350XT Flowable.

Lower filler content composite

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing Invisalign orthodontic treatment

You may not qualify if:

• enamel demineralizations

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Model Details: Split-mouth design

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 1, 2024
• Study Start: March 4, 2024
• Primary Completion: February 10, 2025
• Study Completion: February 15, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)