An interventional study of 3D-Printed Custom Space Maintainer and Conventional Band-and-Loop Space Maintainer in Space Maintenance and Tooth Loss / Rehabilitation, sponsored by Murad Alrashidi. Active, not recruiting at 1 site in Saudi Arabia. Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Murad Alrashidi · Not applicable, Interventional, and Prevention
Purpose of the Study When a child loses a "baby" molar early due to a cavity or injury, the surrounding teeth can shift into the empty space. This often blocks the permanent adult tooth from growing in correctly. To prevent this, dentists use a small metal device called a space maintainer.
This study aims to find out which of three different types of space maintainers lasts the longest, is most comfortable for the child, and is most efficient for the dental office to provide.
The Three Study Groups
Children in this study are randomly assigned to one of three groups:
What is Being Measured?
Researchers are following the children for 12 months to track:
Survival: Which appliance stays glued in and doesn't break most effectively?
Time: How much time does the dentist spend making and fitting the appliance?
Comfort: How much discomfort or pain did the child feel during the process?
Health: Does the appliance cause any irritation to the gums or surrounding teeth?
Who Can Participate? The study includes children between the ages of 5 and 10 who have lost at least one primary (baby) molar early and need a space maintainer to protect their future adult smile.
Importance of This Research By comparing these three methods, this study helps dentists understand if newer technologies, like 3D printing or pre-made kits, are better or more convenient than the traditional lab-made metal loops used for decades. This information will help families choose the best treatment for their children.
Clinical Workflow and Device Fabrication
The trial compares three distinct manufacturing and clinical delivery pathways for pediatric space maintenance:
3D-Printed Custom Workflow (Experimental Arm)
Data Acquisition: Digital impressions are captured using a high-precision intraoral scanner (3Shape TRIOS).
Design Phase: The STL files are imported into CAD software (exocad), where a custom space maintainer is designed with a specific focus on anatomical adaptation to the abutment tooth and the edentulous ridge.
Manufacturing: Appliances are fabricated via Stereolithography (SLA) using a Form 3B+ printer with BioMed Clear Resin. Post-processing includes a 20-minute isopropyl alcohol wash and 60 minutes of UV curing at 60°C to ensure biocompatibility and optimal mechanical properties.
Delivery: The printed appliance is bonded using a light-cured orthodontic adhesive.
Conventional Band-and-Loop Workflow (Active Comparator)
Clinical Phase: Traditional alginate impressions are taken and poured with dental stone to create a physical working model.
Laboratory Phase: A stainless steel band (3M Unitek) is fitted to the abutment tooth on the model. A 0.036-inch stainless steel wire is contoured to the ridge and silver-soldered to the band.
Delivery: The appliance is polished and cemented in a subsequent clinical appointment using glass ionomer cement.
Selection: A prefabricated kit (Denovo Dental) is used to select a band size that fits the abutment tooth.
Assembly: A pre-formed wire loop is selected and adjusted for length at the chairside. The loop is mechanically secured to the band using the system's specialized crimping and locking mechanism, eliminating the need for soldering or laboratory delays.
Delivery: The assembled appliance is cemented during the same appointment as the initial measurement.
Randomization and Standardization Participants are allocated 1:1:1 using a computer-generated randomization sequence. To ensure consistency, all clinical procedures-including tooth preparation, scanning, and cementation-are performed by a group of calibrated pediatric dentists following a standardized protocol. For the 3D-printed group, resin batches and printer calibration are monitored weekly to ensure material integrity.
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 360 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →Murad Alrashidi is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm receive a custom-designed space maintainer fabricated through a fully digital workflow. This involves an intraoral scan (3Shape TRIOS) and CAD design (exocad). The appliance is 3D-printed using stereolithography (SLA) technology (Formlabs Form 3B+) with BioMed Clear Resin, a biocompatible photopolymer. The appliance is bonded to the abutment tooth using a light-cured orthodontic adhesive during a single or subsequent clinical visit.
Device: 3D-Printed Custom Space Maintainer
This arm represents the current clinical reference standard. Fabrication follows a traditional analog workflow beginning with an alginate impression and stone model. A stainless steel band (3M Unitek) is fitted to the model, and a stainless steel wire (0.036-inch) is hand-contoured and silver-soldered to the band. The completed appliance is polished and cemented using glass ionomer cement in a second clinical appointment.
Device: Conventional Band-and-Loop Space Maintainer
This arm utilizes a prefabricated, chairside system (Denovo Dental) designed for single-visit delivery. A pre-sized stainless steel band is selected and fitted directly to the patient's tooth. A pre-formed wire loop is then adjusted for the appropriate span and mechanically secured to the band using a specialized crimping and locking tool, eliminating the need for laboratory soldering. The appliance is cemented during the same appointment as the initial fitting.
Device: Denovo Chairside Space Maintainer
A digitally designed, monolithic space maintainer. The workflow involves an intraoral scan (3Shape TRIOS) and CAD design (exocad). The device is fabricated using stereolithography (SLA) technology (Formlabs Form 3B+) with BioMed Clear Resin. It is bonded to the abutment tooth using a light-cured orthodontic adhesive
The traditional clinical reference standard. It is fabricated using an analog workflow: an alginate impression is taken to create a stone model, a stainless steel band (3M Unitek) is fitted to the model, and a 0.036-inch stainless steel wire is hand-contoured and silver-soldered to the band. The appliance is polished and cemented with glass ionomer cement.
A prefabricated, stainless steel space maintainer system (Denovo Dental) designed for immediate application. A pre-sized band is selected and fitted directly to the patient's tooth. A pre-formed wire loop is adjusted for length at the chairside and mechanically secured to the band using a specialized crimping and locking tool, requiring no laboratory soldering. It is cemented during the initial appointment.
Appliance Survival Rate
This measures the clinical longevity and "success" of the appliance. A "failure" is recorded if the appliance becomes completely or partially dislodged (cement failure), suffers a structural fracture, or causes significant soft-tissue trauma requiring its removal.
Time frame: At 12 months from baseline
Space Maintenance Effectiveness:
Measured as the change in the mesiodistal dimension of the extraction space (in millimeters). Digital calipers or software will compare the initial space at baseline to the space remaining at the end of the study.
Time frame: At 12 month from baseline
Clinical and Laboratory Time (Efficiency)
Researchers will record the active working time (in minutes) for each stage of fabrication. This includes chairside time (scanning or impressions and fitting) and laboratory time (3D printing and post-processing, manual soldering, or chairside assembly).
Time frame: At baseline
Gingival Health (Löe and Silness Index):
A clinical assessment of the soft tissue surrounding the abutment tooth. It will be scored from 0 (normal) to 3 (severe inflammation/bleeding) to determine if any material or design causes more irritation than others.
Time frame: Baseline, at 6 months, and at 12 months.
Plan to share: Yes — The investigators will share the de-identified individual participant data that underlie the results reported in the final publication. This includes primary survival data (time-to-failure), gingival index scores, and recorded fabrication times.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will become available 6 months after the primary manuscript is published in a peer-reviewed journal.
Access criteria: Data will be made available to qualified academic researchers. For researchers who provide a methodologically sound proposal to achieve the aims of the approved proposal (e.g., meta-analysis or validation of digital orthodontic workflows). Data requestors must sign a formal Data Access Agreement to ensure the privacy of the pediatric participants. Requests should be directed to the Principal Investigator.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.
Of 71 non-industry interventional studies with no phase under Tooth Loss, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 77 studies reached it within 28 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Murad Alrashidi