MalocclusionNCT06288386
Impact of Dental Composite Viscosity on Attachment Accuracy: a Prospective Clinical Trial
A study testing GrandioSO Heavy Flow and Filtek Z350XT Flowable in people with Malocclusion, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- GrandioSO Heavy Flow and Filtek Z350XT Flowable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 4 Mar 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergoing Invisalign orthodontic treatment
Who cannot join
- enamel demineralizations
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
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.
Read the 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.
- Conditions
- Malocclusion
- Being tested
- GrandioSO Heavy Flow, Filtek Z350XT Flowable
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrandioSO Heavy FlowDevice
Attachment will be performed with GrandioSO Heavy Flow.
Filtek Z350XT FlowableDevice
Attachment will be performed with Filtek Z350XT Flowable.
| Study group | Role | What they receive |
|---|---|---|
| Higher filler content composite | Experimental | Attachments will be performed with a higher filler content flowable composite resin. Receives: Device: GrandioSO Heavy Flow |
| Lower filler content composite | Active comparator | Attachments will be performed with a lower filler content flowable composite resin. Receives: Device: Filtek Z350XT Flowable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the shape of attachments
The shape changes of attachments will be evaluated through ZEISS Inspect software.
Measured: Baseline
Change in excess of attachments
The excess of attachments will be evaluated through ZEISS Inspect software.
Measured: Baseline
Change in defect of attachments
The defect of attachments will be evaluated through ZEISS Inspect software.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start4 Mar 2024
- Primary completion10 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288386
- Sponsor's protocol ID
- 2024-ATTACHMENTS
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dental Composite Viscosity on Attachment Accuracy: a Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06288386
- Acronym / sponsor ID
- 2024-ATTACHMENTS
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design
| Arm | Type | Receives |
|---|---|---|
| Higher filler content composite | Experimental | Device: GrandioSO Heavy FlowAttachments will be performed with a higher filler content flowable composite resin. |
| Lower filler content composite | Active comparator | Device: Filtek Z350XT FlowableAttachments will be performed with a lower filler content flowable composite resin. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing Invisalign orthodontic treatment
Key exclusion criteria (1 listed)
- enamel demineralizations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GrandioSO Heavy FlowAttachment will be performed with GrandioSO Heavy Flow. | Device | Higher filler content composite |
| Filtek Z350XT FlowableAttachment will be performed with Filtek Z350XT Flowable. | Device | Lower filler content composite |
Primary outcome
Changes in the shape of attachments
Time frame: Baseline
The shape changes of attachments will be evaluated through ZEISS Inspect software.
Change in excess of attachments
Time frame: Baseline
The excess of attachments will be evaluated through ZEISS Inspect software.
Change in defect of attachments
Time frame: Baseline
The defect of attachments will be evaluated through ZEISS Inspect software.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GrandioSO Heavy Flow and Filtek Z350XT Flowable in people with Malocclusion, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the shape of attachments (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.