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

NCT07613658 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 26-20-3
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 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.

Conditions

Space Maintenance; Tooth Loss / Rehabilitation

Keywords

Space Maintenance; Band and Loop; 3D-Printed Space Maintainer; Denovo Space Maintainer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At 12 month from baseline

Secondary Outcomes (2)

• Clinical and Laboratory Time (Efficiency)

  At baseline

• Gingival Health (Löe and Silness Index):

  Baseline, at 6 months, and at 12 months.

Study Arms (3)

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.

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.

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.

Device: Denovo Chairside Space Maintainer

Interventions

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

3D-Printed Custom Space Maintainer

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.

Conventional Band-and-Loop

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.

Denovo Chairside Space Maintainer

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Murad Alrashidi: lead

Study Sites (1)

Qassim University

Buraidah, Al-Qassim Region, 52571, Saudi Arabia

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• MURAD ALRASHIDI, BDS, MSC

  Qassim University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MURAD A ALRASHIDI, Pediatric Orthodontist

CONTACT

+966 55 302 2773; MU.ALRASHIDI@qu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Orthodontics and Pediatric Dentistry

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

SA (1)