Clinical Evaluation of 3D Printed vs CAD/CAM Rehabilitation of Primary Anterior Teeth Loss
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Tanta University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Clinical survival rate
Study Overview
Brief Summary
compare 3D Printed versus CAD/CAM fabricated modified fixed appliance for rehabilitation of premature loss of anterior teeth in preschool children
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Healthy children (ASA I or II)
- •Premature loss of one to four maxillary primary incisors
- •At least 6 months remaining before the expected eruption of the permanent successor
- •Presence of sufficient healthy abutment teeth (primary canines)
- •Adequate oral hygiene (Plaque Index ≤1).
- •Cooperative child (Frankl Behavior Rating 3, 4).
Exclusion Criteria
- •Children with craniofacial anomalies or syndromes (e.g., cleft lip and palate).
- •Children with developmental dental anomalies affecting the anterior region (e.g., hypodontia, severe enamel defects).
- •Severe gingivitis or periodontal disease around the abutment teeth.
- •Deep bite, severe malocclusion, or traumatic occlusion that could interfere with appliance function.
- •Parafunctional habits that could increase appliance failure( Bruxism, Nail biting, Biting hard objects).
- •Persistent oral habits that may affect appliance stability
Arms & Interventions
CAD/CAM fabricated modified fixed bridge
the modified fixed bridges were fabricated using CAD/CAM technology
Intervention: CAD/CAM fabricated modified fixed bridge (Device)
3D Printed modified fixed bridge
the modified fixed bridges were fabricated using 3D Printing technology
Intervention: 3D Printed modified fixed bridge (Device)
Outcomes
Primary Outcomes
Clinical survival rate
Time Frame: 12 months
Debonding, breakage of appliance ( failure causes)
Gingival health
Time Frame: 12 months
Gingival index will be assessed by clinician
Esthetic evaluation
Time Frame: 12 months
child and parent evaluation of restoring child esthetics using visual analog scale
Secondary Outcomes
- Questionnaire(12 months)
Investigators
nora mostafa mohammed abo shanady
Lecturer of Pediatric Dentistry, Faculty of Dentistry, Tanta university
Tanta University