NCT06798090

Evaluation of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique

Evaluation of Clinical Success and Changes in Periodontal Tissues of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Aydin Adnan Menderes University · Academic / Other
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

Our research is planned as a randomised clinical trial. The main aim of our study is to evaluate the clinical success of band and loop space maintainers produced by three-dimensional printer and conventional technique and the changes they cause in periodontal tissues.

Detailed description

Participants will be selected by simple random selection from systemically healthy children who will need bilateral lower deciduous first molar extraction and space maintainer application from patients who apply to Aydın Adnan Menderes University Faculty of Dentistry, Department of Pedodontics for treatment. The study will be carried out in a split-mouth design, and it is planned to place a band and loop space maintainer produced by conventional technique on one side and a band and loop space maintainer produced with a three-dimensional printer on the other side in the lower jaw. The clinical success of these two appliances and the changes in periodontal tissues will be compared. In order to evaluate the clinical success, the survival of the appliances and the determined failure criteria (Dissolution of the bonding cement, Separation/breakage from solder area, Embedding of the space maintainer inside towards the gum, Loop distortion/breakage, Inflammation of the gingiva adjacent to/around the space maintainer, Plaque accumulation around the band) will be taken into consideration. In order to evaluate the effects on periodontal tissues, pocket depth, plaque index values, gingival index values will be recorded and PLAP-1 and TNF-a levels in the gingival groove fluid will be examined for more detailed periodontal examination. The total planned follow-up period is 18 months, with patients invited for follow-up appointments at six-month intervals. Evaluations will be made at the end of the study with repeated measurements at baseline and control sessions.

Conditions

• Dental Health
• Space Maintainer
• Pediatric Dentistry
• 3D Printing

Interventions

Type	Name	Description
DEVICE	Band and Loop Space Maintainer Produced with Three-Dimensional Printer	Band and loop space maintainer produced with three-dimensional printer using micro laser sinterisation method
DEVICE	Band and Loop Space Maintainer Produced with Conventional Technique	Band and loop space maintainer produced with conventional methods

Timeline

• Start date: 2024-10-15
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2025-01-29
• Last updated: 2025-01-29

Locations

1 site across 1 country: Turkey (Türkiye)