Tooth LossNCT06750068
Evaluation of 3D-printed Space Maintainers Versus Conventional Space Maintainer : a Randomized Clinical Trial
A study testing 3D printed space maintainer and Conventional space maintainer in people with Tooth Loss, run by Cairo University.
Trial summary
This study aims to compare the clinical evaluation and patients' satisfaction of space maintainers produced by digital workflow using the 3D-printing method (3D-SMs) versus conventional band and loop space maintainers (C-SMs) produced by traditional methods. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- 3D printed space maintainer and Conventional space maintainer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Lower first permanent molar in active state of eruption
- Patient and parent showing cooperation and compliance.
- Medically free children.
- According to space analysis available space is less than or equal to needed space
- Primary molar loss in the last 1 week due to caries, infection, and resorption (to eliminate possible space loss)
- Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines.
Who cannot join
- Children with previous allergies to stainless steel.
- There was less than one year left for the permanent tooth to erupt (to prevent possible abutment toot loss)
- The patient's oral hygiene is not sufficient and has periodontal problems (to accurately assess the periodontal effects)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of Digitally Fabricated 3D-printed Band and Loop Space Maintainers Versus Conventional Band and Loop Space Maintainer : a Randomized Clinical Trial
This study aims to compare the clinical evaluation and patients' satisfaction of space maintainers produced by digital workflow using the 3D-printing method (3D-SMs) versus conventional band and loop space maintainers (C-SMs) produced by traditional methods.
- Conditions
- Tooth Loss
- Being tested
- 3D printed space maintainer, Conventional space maintainer
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed space maintainerOther
Digitally fabricated #d printed space maintainer
Conventional space maintainerOther
Stainless steel space maintains
| Study group | Role | What they receive |
|---|---|---|
| Conventional band and loop space maintainer | Active comparator | Impressions will be taken from the patients with sterilized plastic pedodontic impression trays and alginate under standard conditions by the same researcher. Alginate will be mixed in accordance with the manufacturer's instructions. After the impressions, plaster study casts will be produced and sent to the laboratory. Conventional SMs will be produced by soldering the 0.7-mm bent orthodonic wires (Dentaurum, Germany) onto previously selected prefabricated molar bands. Prefabricated molar bands (Dentaurum, Germany) in the patient's mouth will be chosen by the physician and then sent to the laboratory with the casts.
All SMs will be cemented by the same investigator under standard conditions using a glass-ionomer luting cement (Nova Glass-L, Imicryl, Konya, Turkey). Receives: Other: Conventional space maintainer |
| 3D printed space maintainer | Experimental | Patients in this group will be scanned under standard conditions with Medit i500 (Medit Corp. Seoul, South Korea). The scanned data of the patients will be sent to the laboratory via email in Standard Triangle Language (STL) file format.The design of SMs will be carried out on the DentalCAD 2.2 Valletta (Exocad GmbH, Darmstadt, Germany) program to mimic the conventional space maintainer, and the production will be made by the 3D Selective laser melting (SLM Solutions, Germany) method using titanium-based metal powder (Ti64 Gd23; LPW Technology Ltd., Cheshire, UK). The production of 3D-SMs will start in accordance with the C-SM design in many points, such as the fit of the part surrounding the abutment tooth, thickness, and the position of the loop of 3D-SM.
All SMs will be cemented by the same investigator under standard conditions using a glass-ionomer luting cement (Nova Glass-L, Imicryl, Konya, Turkey). Receives: Other: 3D printed space maintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Decementation, debonding, solder breakage, loop breakage, band breakage, and abutment tooth fracture will be evaluated clinically for both space maintainers
Measured: 1 year
Secondary outcomes (3)
Gingival health of the abutment
Gingival index 0 = normal gingiva; 1 = mild inflammation: slight change in color, slight edema, no bleeding on probing; 2 = moderate inflammation: redness, edema, and glazing, or bleeding on probing; 3 = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding
Measured: 0,6,12 months
Plaque accumulation on the abutment tooth
Plaque index Score 0: No Plaque Score 1:Thin plaque layer at the gingival margin, only detectable by scraping with a probe Score 2: Moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye Score 3:Abundant plaque along the gingival margin; interdental spaces filled with plaque
Measured: 0,6,12 months
Patients' satisfaction about the impression technique
Five- question survey
- "Was the impression easy and fun?"
- "Did you have nausea during impression?"
- "Did you feel any discomfort during the impression (taste, odor, foreign body)?"
- "Did the impression take a short time?"
- "Would you like to have this impression experience again?"
Measured: Immediately after the im- pression/scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start20 Mar 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- 3D printed band and loop space maintainer Conventions band and loop space maintainer
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Alaa Abdelaziz Elsayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750068
- Sponsor's protocol ID
- 16111992ayaalaaabdelazizelsaye
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Digitally Fabricated 3D-printed Band and Loop Space Maintainers Versus Conventional Band and Loop Space Maintainer : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06750068
- Acronym / sponsor ID
- 16111992ayaalaaabdelazizelsaye
- Conditions
- Tooth Loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 27 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.
This study aims to compare the clinical evaluation and patients' satisfaction of space maintainers produced by digital workflow using the 3D-printing method (3D-SMs) versus conventional band and loop space maintainers (C-SMs) produced by traditional methods.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 3D printed band and loop space maintainer Conventions band and loop space maintainer
| Arm | Type | Receives |
|---|---|---|
| Conventional band and loop space maintainer | Active comparator | Other: Conventional space maintainerImpressions will be taken from the patients with sterilized plastic pedodontic impression trays and alginate under standard conditions by the same researcher. Alginate will be mixed in accordance with the manufacturer's instructions. After the impressions, plaster study casts will be produced and sent to the laboratory. Conventional SMs will be produced by soldering the 0.7-mm bent orthodonic wires (Dentaurum, Germany) onto previously selected prefabricated molar bands. Prefabricated molar bands (Dentaurum, Germany) in the patient's mouth will be chosen by the physician and then sent to the laboratory with the casts. All SMs will be cemented by the same investigator under standard conditions using a glass-ionomer luting cement (Nova Glass-L, Imicryl, Konya, Turkey). |
| 3D printed space maintainer | Experimental | Other: 3D printed space maintainerPatients in this group will be scanned under standard conditions with Medit i500 (Medit Corp. Seoul, South Korea). The scanned data of the patients will be sent to the laboratory via email in Standard Triangle Language (STL) file format.The design of SMs will be carried out on the DentalCAD 2.2 Valletta (Exocad GmbH, Darmstadt, Germany) program to mimic the conventional space maintainer, and the production will be made by the 3D Selective laser melting (SLM Solutions, Germany) method using titanium-based metal powder (Ti64 Gd23; LPW Technology Ltd., Cheshire, UK). The production of 3D-SMs will start in accordance with the C-SM design in many points, such as the fit of the part surrounding the abutment tooth, thickness, and the position of the loop of 3D-SM. All SMs will be cemented by the same investigator under standard conditions using a glass-ionomer luting cement (Nova Glass-L, Imicryl, Konya, Turkey). |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Lower first permanent molar in active state of eruption
- Patient and parent showing cooperation and compliance.
- Medically free children.
- According to space analysis available space is less than or equal to needed space
- Primary molar loss in the last 1 week due to caries, infection, and resorption (to eliminate possible space loss)
Key exclusion criteria (3 listed)
- Children with previous allergies to stainless steel.
- There was less than one year left for the permanent tooth to erupt (to prevent possible abutment toot loss)
- The patient's oral hygiene is not sufficient and has periodontal problems (to accurately assess the periodontal effects)
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 |
|---|---|---|
| 3D printed space maintainerDigitally fabricated #d printed space maintainer | Other | 3D printed space maintainer |
| Conventional space maintainerStainless steel space maintains | Other | Conventional band and loop space maintainer |
Primary outcome
Survival rate
Time frame: 1 year
Decementation, debonding, solder breakage, loop breakage, band breakage, and abutment tooth fracture will be evaluated clinically for both space maintainers
3 secondary outcomes
Gingival health of the abutment
Time frame: 0,6,12 months
Plaque accumulation on the abutment tooth
Time frame: 0,6,12 months
Patients' satisfaction about the impression technique
Time frame: Immediately after the im- pression/scanning
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed space maintainer and Conventional space maintainer in people with Tooth Loss, run by Cairo University.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Alaa Abdelaziz Elsayed, Assistant lecturer (+201090802757, aya.alaa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 1 year). 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 19 Mar 2025.