Space MaintenanceNCT07613658
3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition.
A study testing 3D-Printed Custom Space Maintainer, Conventional Band-and-Loop Space Maintainer and Denovo Chairside Space Maintainer in people with Space Maintenance and Tooth Loss / Rehabilitation, run by Murad Alrashidi at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Space Maintenance, Tooth Loss / Rehabilitation
- What is being tested?
- 3D-Printed Custom Space Maintainer, Conventional Band-and-Loop Space Maintainer and Denovo Chairside Space Maintainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2026to Jul 2027
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5 to 10 years
- Premature unilateral loss of at least one primary first or second molar
- Radiographically confirmed developing permanent successor at Nolla developmental stage 4 to 7
- Parent or legal guardian able and willing to provide written informed consent, and child able to provide age-appropriate assent
Who cannot join
- Systemic disease affecting bone metabolism or tooth development
- Clinically significant mesiodistal space loss at screening, defined as greater than 3 mm
- Poor oral hygiene precluding band placement, defined as a full-mouth plaque score greater than 50%
- Known allergy or hypersensitivity to stainless steel or resin components
- Current participation in another interventional clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D-Printed Custom Versus Conventional Band-and-Loop Versus Chairside Denovo Space Maintainers in the Primary Dentition: A Randomized Controlled Trial Protocol
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.
Read more
The Three Study Groups
Children in this study are randomly assigned to one of three groups:
- 3D-Printed Custom Group: The dentist takes a digital picture (scan) of the child's mouth instead of a traditional mold. A custom-fit appliance is then 3D-printed using a specialized, medical-grade clear material.
- Conventional Band-and-Loop Group: This is the traditional method. The dentist takes a physical mold of the teeth, which is sent to a laboratory. The child usually has to return for a second appointment a week later to have the metal appliance glued into place.
- Denovo Chairside Group: This uses a kit of pre-made metal parts. The dentist selects the best fit and assembles the appliance right at the chairside, allowing it to be placed during a single visit.
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.
Read the detailed description
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.
- Denovo Chairside Workflow (Active Comparator)
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.
- Conditions
- Space Maintenance, Tooth Loss / Rehabilitation
- Being tested
- 3D-Printed Custom Space Maintainer, Conventional Band-and-Loop Space Maintainer, Denovo Chairside Space Maintainer
- Keywords
- Space Maintenance, Band and Loop, 3D-Printed Space Maintainer, Denovo 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 Custom Space MaintainerDevice
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
Conventional Band-and-Loop Space MaintainerDevice
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.
Denovo Chairside Space MaintainerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 3D-Printed Custom Space Maintainer | Experimental | 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. Receives: Device: 3D-Printed Custom Space Maintainer |
| Conventional Band-and-Loop | Active comparator | 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. Receives: Device: Conventional Band-and-Loop Space Maintainer |
| Denovo Chairside Space Maintainer | Active comparator | 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. Receives: Device: Denovo Chairside Space Maintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 12 month from baseline
Secondary outcomes (2)
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).
Measured: 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.
Measured: Baseline, at 6 months, and at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Space MaintenanceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murad Alrashidi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murad Alrashidi, Qassim University
- Investigators
- MURAD ALRASHIDI, BDS, MSC, Principal investigator, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613658
- Sponsor's protocol ID
- 26-20-3
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-Printed Custom Versus Conventional Band-and-Loop Versus Chairside Denovo Space Maintainers in the Primary Dentition: A Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT07613658
- Acronym / sponsor ID
- 26-20-3
- Conditions
- Space Maintenance, Tooth Loss / Rehabilitation
- Keywords
- Space Maintenance, Band and Loop, 3D-Printed Space Maintainer, Denovo Space Maintainer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Murad AlrashidiUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 29 May 2026 (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.
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:
- 3D-Printed Custom Group: The dentist takes a digital picture (scan) of the child's mouth instead of a traditional mold. A custom-fit appliance is then 3D-printed using a specialized, medical-grade clear material.
- Conventional Band-and-Loop Group: This is the traditional method. The dentist takes a physical mold of the teeth, which is sent to a laboratory. The child usually has to return for a second appointment a week later to have the metal appliance glued into place.
- Denovo Chairside Group: This uses a kit of pre-made metal parts. The dentist selects the best fit and assembles the appliance right at the chairside, allowing it to be placed during a single visit.
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.
Detailed description
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.
- Denovo Chairside Workflow (Active Comparator)
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3D-Printed Custom Space Maintainer | Experimental | Device: 3D-Printed Custom Space MaintainerParticipants 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. |
| Conventional Band-and-Loop | Active comparator | Device: Conventional Band-and-Loop Space MaintainerThis 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. |
| Denovo Chairside Space Maintainer | Active comparator | Device: Denovo Chairside Space MaintainerThis 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. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 5 to 10 years
- Premature unilateral loss of at least one primary first or second molar
- Radiographically confirmed developing permanent successor at Nolla developmental stage 4 to 7
- Parent or legal guardian able and willing to provide written informed consent, and child able to provide age-appropriate assent
Key exclusion criteria (5 listed)
- Systemic disease affecting bone metabolism or tooth development
- Clinically significant mesiodistal space loss at screening, defined as greater than 3 mm
- Poor oral hygiene precluding band placement, defined as a full-mouth plaque score greater than 50%
- Known allergy or hypersensitivity to stainless steel or resin components
- Current participation in another interventional clinical trial
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 Custom Space MaintainerA 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 | Device | 3D-Printed Custom Space Maintainer |
| Conventional Band-and-Loop Space MaintainerThe 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. | Device | Conventional Band-and-Loop |
| Denovo Chairside Space MaintainerA 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. | Device | Denovo Chairside Space Maintainer |
Primary outcome
Appliance Survival Rate
Time frame: At 12 months from baseline
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.
Space Maintenance Effectiveness:
Time frame: At 12 month from baseline
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.
2 secondary outcomes
Clinical and Laboratory Time (Efficiency)
Time frame: At baseline
Gingival Health (Löe and Silness Index):
Time frame: Baseline, at 6 months, and at 12 months.
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 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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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.
MURAD ALRASHIDI, BDS, MSC principal investigator
Qassim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Printed Custom Space Maintainer, Conventional Band-and-Loop Space Maintainer and Denovo Chairside Space Maintainer in people with Space Maintenance and Tooth Loss / Rehabilitation, run by Murad Alrashidi at 1 site in Saudi Arabia.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. 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 Saudi Arabia. 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?
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?
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?
Appliance Survival Rate (time frame: At 12 months from baseline). The study lists 2 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 13 Oct 2026.