Dental CrownsKOS&METNCT06744153
Clinical Outcomes of Functional Space Maintainers Designed Using CAD/CAM Technology in Early Loss of the First Primary Molar
A study testing Space Maintainer in people with Dental Crowns and Orthodontics, Interceptive, run by Rasa Mladenovic at 1 site in Serbia.
Trial summary
As passive fixed space maintainers do not replace the lost tooth and therefore do not provide a chewing function, this study aims to evaluate the efficiency of an innovative solution for maintaining space after the premature extraction of first primary molars using functional space maintainers based on CAD/CAM… Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Dental Crowns, Orthodontics, Interceptive, Orthodontic Appliance
- What is being tested?
- Space Maintainer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Dec 2022to 30 Nov 2024
- 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Indication for extraction or premature loss of the first primary molar in the upper or lower jaw.
- A prolonged time period from the loss of the primary tooth to the eruption of its successor (with bone tissue present above the successor tooth on the radiograph).
- A complete dental arch on the contrary side of the jaw.
- Intact or adequately restored vital second primary molars in the region indicated for the placement of a space maintainer.
Who cannot join
- Systemic disorders and uncooperative children.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Faculty od Medical Sciences University of Kragujevac
Kragujevac, 34000
About this study
Official title: Innovative Functional Space Maintainers Designed Using CAD/CAM Technology
As passive fixed space maintainers do not replace the lost tooth and therefore do not provide a chewing function, this study aims to evaluate the efficiency of an innovative solution for maintaining space after the premature extraction of first primary molars using functional space maintainers based on CAD/CAM technology.
Read the detailed description
The innovative design of a functional space maintainer named KOS\&MET (Key Orthodontic System and Materials Enhanced Therapy) was created using 3Shape Dental Designer (3Shape A/S, Copenhagen, Denmark). The functional maintainer features an intraoral window for monitoring the eruption of the successor tooth. In addition to its role in maintaining space, the maintainer is designed to restore bilateral chewing function. In addition to the loop encircling the second primary molar, the space maintainer includes a crown for the missing first primary molar. To achieve optimal anatomical details, we applied a mirror model of the molar from the contrary side.
Space maintainers were fabricated using CAD/CAM technology in two ways: 3D printing and milling.
- 3D Print (Metal) - Additive Method: In this group, the functional space maintainer was fabricated from a metal alloy (Co 69%, Cr 25%, W 9.5%, Mo 3.5%, Si 1%, Scheftner, Germany) using a 3D printer (MySint100 Dual Laser, Italy).
- Milling (Composite) - Subtractive Method: A dental milling machine (Wieland Zenotec Select Hybrid, Germany) was used to fabricate functional space maintainers from a polymer composite material (breCAM.HIPC, Bredent, Germany).
- Being tested
- Space Maintainer
- Keywords
- functional space maintainers, CAD/CAM, 3D printing, Milling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Space MaintainerProcedure or surgery
Fabrication of KOS\&MET functional space maintainer and its cementation.
| Study group | Role | What they receive |
|---|---|---|
| 3D Print | Active comparator | 3D Print (Metal) - Additive Method: In this group, the functional space maintainer was fabricated from a metal alloy (Co 69%, Cr 25%, W 9.5%, Mo 3.5%, Si 1%, Scheftner, Germany) using a 3D printer (MySint100 Dual Laser, Italy). Receives: Procedure: Space Maintainer |
| Milling | Active comparator | Milling (Composite) - Subtractive Method: A dental milling machine (Wieland Zenotec Select Hybrid, Germany) was used to fabricate functional space maintainers from a polymer composite material (breCAM.HIPC, Bredent, Germany) Receives: Procedure: Space Maintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation - Fractures and decementing
The condition of the abutment teeth and surrounding soft tissues, as well as potential fractures or decementing of the space maintainer, were inspected at 1, 3, and 6 months.
Measured: 6 months
Secondary outcomes (1)
Bite Force (Newtone)
Maximum Occlusal Bite Force in Newtones: Measured using a specially designed dynamometer (RABiter, Kragujevac, Serbia) directly on the space maintainer, with the contrary side of the jaw used as a control.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start15 Dec 2022
- Primary completion20 Aug 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CrownsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rasa Mladenovic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rasa Mladenovic, University of Kragujevac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744153
- Sponsor's protocol ID
- 01-14789/2022
- Other IDs
- Ethics Committee
- Acronym
- KOS&MET
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Functional Space Maintainers Designed Using CAD/CAM Technology
- ClinicalTrials.gov ID
- NCT06744153
- Acronym / sponsor ID
- KOS&MET / 01-14789/2022
- Keywords
- functional space maintainers, CAD/CAM, 3D printing, Milling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Rasa MladenovicUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 20 Dec 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.
As passive fixed space maintainers do not replace the lost tooth and therefore do not provide a chewing function, this study aims to evaluate the efficiency of an innovative solution for maintaining space after the premature extraction of first primary molars using functional space maintainers based on CAD/CAM technology.
Detailed description
The innovative design of a functional space maintainer named KOS\&MET (Key Orthodontic System and Materials Enhanced Therapy) was created using 3Shape Dental Designer (3Shape A/S, Copenhagen, Denmark). The functional maintainer features an intraoral window for monitoring the eruption of the successor tooth. In addition to its role in maintaining space, the maintainer is designed to restore bilateral chewing function. In addition to the loop encircling the second primary molar, the space maintainer includes a crown for the missing first primary molar. To achieve optimal anatomical details, we applied a mirror model of the molar from the contrary side.
Space maintainers were fabricated using CAD/CAM technology in two ways: 3D printing and milling.
- 3D Print (Metal) - Additive Method: In this group, the functional space maintainer was fabricated from a metal alloy (Co 69%, Cr 25%, W 9.5%, Mo 3.5%, Si 1%, Scheftner, Germany) using a 3D printer (MySint100 Dual Laser, Italy).
- Milling (Composite) - Subtractive Method: A dental milling machine (Wieland Zenotec Select Hybrid, Germany) was used to fabricate functional space maintainers from a polymer composite material (breCAM.HIPC, Bredent, Germany).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Print | Active comparator | Procedure: Space Maintainer3D Print (Metal) - Additive Method: In this group, the functional space maintainer was fabricated from a metal alloy (Co 69%, Cr 25%, W 9.5%, Mo 3.5%, Si 1%, Scheftner, Germany) using a 3D printer (MySint100 Dual Laser, Italy). |
| Milling | Active comparator | Procedure: Space MaintainerMilling (Composite) - Subtractive Method: A dental milling machine (Wieland Zenotec Select Hybrid, Germany) was used to fabricate functional space maintainers from a polymer composite material (breCAM.HIPC, Bredent, Germany) |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Indication for extraction or premature loss of the first primary molar in the upper or lower jaw.
- A prolonged time period from the loss of the primary tooth to the eruption of its successor (with bone tissue present above the successor tooth on the radiograph).
- A complete dental arch on the contrary side of the jaw.
- Intact or adequately restored vital second primary molars in the region indicated for the placement of a space maintainer.
Key exclusion criteria (1 listed)
- Systemic disorders and uncooperative children.
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 |
|---|---|---|
| Space MaintainerFabrication of KOS\&MET functional space maintainer and its cementation. | Procedure or surgery | 3D Print, Milling |
Primary outcome
Clinical Evaluation - Fractures and decementing
Time frame: 6 months
The condition of the abutment teeth and surrounding soft tissues, as well as potential fractures or decementing of the space maintainer, were inspected at 1, 3, and 6 months.
1 secondary outcome
Bite Force (Newtone)
Time frame: 1 Day
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 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Space Maintainer in people with Dental Crowns and Orthodontics, Interceptive, run by Rasa Mladenovic at 1 site in Serbia.
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 4 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 27 Dec 2024. 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 Serbia. 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?
Clinical Evaluation - Fractures and decementing (time frame: 6 months). 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 27 Dec 2024.