Идёт набор NCT06798090

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

Без фазы С лечением Dental Health Space Maintainer Pediatric Dentistry 3D Printing

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Band and Loop Space Maintainer Produced with Three-Dimensional Printer, Band and Loop Space Maintainer Produced with Conventional Technique.
Кому может быть актуально: Состояния в реестре: Dental Health, Space Maintainer, Pediatric Dentistry, 3D Printing. Базовые параметры: 5 лет — 8 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Устройство 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
Устройство Band and Loop Space Maintainer Produced with Conventional Technique
Band and loop space maintainer produced with conventional methods

Первичные конечные точки

Clinical success [Срок оценки: Up to 18 months]
Evaluation of periodontal tissue changes around both space maintainers according to the periodontal pocket depth measuring [Срок оценки: Up to 18 months]
Evaluation of periodontal tissue changes around both space maintainers according to Plaque index values [Срок оценки: Up to 18 months]
Evaluation of periodontal tissue changes around both space maintainers according to the gingival index values [Срок оценки: Up to 18 months]
Evaluation of periodontal tissue changes around both space maintainers with gingival groove fluid examination [Срок оценки: Baseline and 6.month]

Вторичные конечные точки (2)

Measuring space maintaining efficiency [Срок оценки: Up to18 months]
Comparing the two impression methods in terms of patient satisfaction. [Срок оценки: Immediately after the impression procedure]

Критерии участия

Критерии включения

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