Evaluation of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Band and Loop Space Maintainer Produced with Three-Dimensional Printer, Band and Loop Space Maintainer Produced with Conventional Technique.
- Who it may be relevant to
- Registry conditions: Dental Health, Space Maintainer, Pediatric Dentistry, 3D Printing. Basic parameters: 5 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Clinical Success and Changes in Periodontal Tissues of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique
Overview
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.
Interventions
- 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
Primary outcome measures
- Clinical success [Time frame: Up to 18 months]
- Evaluation of periodontal tissue changes around both space maintainers according to the periodontal pocket depth measuring [Time frame: Up to 18 months]
- Evaluation of periodontal tissue changes around both space maintainers according to Plaque index values [Time frame: Up to 18 months]
- Evaluation of periodontal tissue changes around both space maintainers according to the gingival index values [Time frame: Up to 18 months]
- Evaluation of periodontal tissue changes around both space maintainers with gingival groove fluid examination [Time frame: Baseline and 6.month]
Secondary outcome measures (2)
- Measuring space maintaining efficiency [Time frame: Up to18 months]
- Comparing the two impression methods in terms of patient satisfaction. [Time frame: Immediately after the impression procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Turkey (Türkiye) · 1 center
- Aydın Adnan Menderes University — Aydin
Identifiers
NCT: NCT06798090 · 2023/21