Health TrialsbyHealthPanel

3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition.

ConditionsSpace MaintenanceTooth Loss / Rehabilitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-10
SponsorMurad Alrashidi

About this trial

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:

1. 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. 2. 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. 3. 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3D-Printed Custom Space Maintainer

    Device

    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 Maintainer

    Device

    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 Maintainer

    Device

    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.

Treatment groups

360 Participants
are divided into 3 treatment groups
Group A: 3D-Printed Custom Space MaintainerExperimental treatment 1 intervention
Group B: Conventional Band-and-LoopActive comparator 1 intervention
Group C: Denovo Chairside Space MaintainerActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Murad Alrashidi

Lead sponsor

Qassim University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: