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Active, not recruitingNCT07752147Updated Sep 25, 2026

3D Printed vs CAD/CAM Rehabilitation of Primary Anterior Teeth Loss

An interventional study of 3D Printed modified fixed bridge and CAD/CAM fabricated modified fixed bridge in Modified Fixed Bridge, sponsored by Tanta University. Active, not recruiting at 1 site in Egypt. Open to participants aged 3 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
3 Years to 5 Years
Sex
All
01

Study summary

compare 3D Printed versus CAD/CAM fabricated modified fixed appliance for rehabilitation of premature loss of anterior teeth in preschool children

Read the detailed description

The study will be conducted as a clinical trial and it will be carried out at Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. Forty preschool children from both genders aged from 3-5 years will be included in the study. The selected children will be divided into two groups.

Group I: Twenty children will receive 3D Printed modified fixed bridge. Group II: Twenty will receive CAD/CAM fabricated modified fixed bridge. Evaluation of both appliances will be carried out at baseline, 6 and 12 months

02

Conditions studied

  • Modified Fixed Bridge

Keywords

  • 3D Printed
  • CAD/CAM
  • modified fixed bridge
  • anterior teeth loss
03

Who can participate

Ages eligible
3 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Healthy children (ASA I or II)
  2. Premature loss of one to four maxillary primary incisors
  3. At least 6 months remaining before the expected eruption of the permanent successor
  4. Presence of sufficient healthy abutment teeth (primary canines)
  5. Adequate oral hygiene (Plaque Index ≤1).
  6. Cooperative child (Frankl Behavior Rating 3, 4).

Exclusion criteria

Exclusion Criteria:

  1. Children with craniofacial anomalies or syndromes (e.g., cleft lip and palate).
  2. Children with developmental dental anomalies affecting the anterior region (e.g., hypodontia, severe enamel defects).
  3. Severe gingivitis or periodontal disease around the abutment teeth.
  4. Deep bite, severe malocclusion, or traumatic occlusion that could interfere with appliance function.
  5. Parafunctional habits that could increase appliance failure( Bruxism, Nail biting, Biting hard objects).
  6. Persistent oral habits that may affect appliance stability
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    3D Printed modified fixed bridge

    the modified fixed bridges were fabricated using 3D Printing technology

    Device: 3D Printed modified fixed bridge

  • Active comparator
    CAD/CAM fabricated modified fixed bridge

    the modified fixed bridges were fabricated using CAD/CAM technology

    Device: CAD/CAM fabricated modified fixed bridge

Interventions

  • Device3D Printed modified fixed bridge

    the 3D Printed modified fixed appliances compared to CAD/CAM fabricated ones for rehabilitation of premature loss of anterior teeth

  • DeviceCAD/CAM fabricated modified fixed bridge

    the CAD/CAM fabricated modified fixed bridge used a active control

05

What researchers measure

Primary outcomes

  1. Clinical survival rate

    Debonding, breakage of appliance ( failure causes)

    Time frame: 12 months

  2. Gingival health

    Gingival index will be assessed by clinician

    Time frame: 12 months

  3. Esthetic evaluation

    child and parent evaluation of restoring child esthetics using visual analog scale

    Time frame: 12 months

Secondary outcomes

  1. Questionnaire

    determine whether one appliance provides greater improvements in: Eating and chewing ability, Speech, Smile appearance, Child confidence and social interaction, Parent satisfaction and reduced family concern.

    Time frame: 12 months

06

Study locations

1 site
  • Faculty of Dentistry
    Tanta, 31111, Egypt
07

References and documents

Publications

  • Ghaly M, Hamila NA. Evaluation of anterior fixed appliances on maxillary arch growth in preschool children. Sci Rep. 2025 Jan 29;15(1):3628. doi: 10.1038/s41598-025-87005-8. PubMed 39880849 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07752147
Lead sponsor
Tanta University
Responsible party
nora mostafa mohammed abo shanady (Lecturer of Pediatric Dentistry, Faculty of Dentistry, Tanta university, Tanta University) — Principal investigator
First posted
Aug 7, 2026
Start date
Jul 11, 2025
Primary completion
Jul 13, 2026
Completion
Oct 3, 2026 (estimated)
Last update
Sep 25, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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