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

Aydin Adnan Menderes University

Status: Enrolling

Conditions: 3D Printing; Pediatric Dentistry; Space Maintainer; Dental Health

Treatments: Device: Band and Loop Space Maintainer Produced with Conventional Technique; Device: Band and Loop Space Maintainer Produced with Three-Dimensional Printer

Study type: Interventional

Funder types: Other

Identifiers

NCT06798090

2023/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 estimated patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Systemically healthy children
• Bilateral early loss of deciduous first molar teeth in the lower jaw
• Presence of radiographically confirmed permanent tooth germ under the extracted deciduous tooth
• Radiographically determined 1,5 mm minimum of bone existence above the permanent tooth germ
• Existence of flush terminal plane/mesial step in decidious dentition and Angle class 1 molar relationship in mixed dentition
• Existence of radiographically and clinically healthy abutment teeth
• Frankl score 3 and 4 children

Exclusion criteria

• Patients with systemic diseases
• Frankl score 1 and 2 children

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Band and Loop Space Maintainer Produced with Three-Dimensional Printer (Study Group)

Experimental group

Description:

Digital impressions will be taken with 3Shape intraoral scanner. Space maintainer will be designed with CAD/CAM technology. The three-dimensional printer to be used is HBD - 150D Dual Laser, and production will be made by micro laser sinterisation method from nickel - chromium weighted metal powders.

Treatment:

Device: Band and Loop Space Maintainer Produced with Three-Dimensional Printer

Band and Loop Space Maintainer Produced with Conventional Technique (Control Group)

Active Comparator group

Description:

For conventional production, impressions will be taken with traditional impression spoons using alginate material. Stainless steel appropriate band will be chosen according to the size of the abutment teeth, then will be send to the laboratory for soldering.

Treatment:

Device: Band and Loop Space Maintainer Produced with Conventional Technique