Идёт набор NCT06407271

Effect of Abutment Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial

Без фазы С лечением Dental Implants, Single-Tooth Dental Implant-Abutment Design

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: CAD/CAM custom ZrO2 healing abutment, Cylindrical ZrO2 healing abutment.
Кому может быть актуально: Состояния в реестре: Dental Implants, Single-Tooth, Dental Implant-Abutment Design. Базовые параметры: от 18 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: Венгрия
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

Effect of Abutment 3-dimensional Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial

Обзор

The aims of our study are to investigate in patients with immediate implantation replacing a single tooth in the maxillary anterior (#FDI 15-25) region the effect of (a) custom vs cylindrical stock healing abutments, then (b) screw retained single ceramic crowns, on the peri implant hard- and soft-tissue formation and blood flow.

Подробное описание

AIMS:

In the maxilla, in the aesthetic zone, in patients with a thick phenotype, for a crown anchored with a solo immediate implant:

I.A To investigate hard and soft tissue volume changes around custom CAD/CAM (computer-aided design and manufacturing) vs. cylindrical zirconiom-dioxide (ZrO2) healing abutments 4 months after their fixation for immediate implant placement.

I.B To measure the thickness of keratinized mucosa by ultrasound I.C Monitoring microcirculation in wound healing by laser speckle contrast imaging (LSCI) and ultrasound.

II. Custom zirconia abutment (on Ti-base) retained, screw-retained all-ceramic solo restorations:

* Evaluation of hard and soft tissue volume changes * Esthetic evaluation (Pink and White Aesthetic Scores (PES, WES)), FIPS (functional implant prosthodontic score), pain, follow-up of biological and technical complications at 1 and 3 years.

ARMS:

A. immediate implantation + cylindrical healing abutment + CAD/CAM screw-retained (on Ti-base), full-countour monolithic zirconium-dioxide restoration

B. immediate implantation + custom healing abutment + CAD/CAM screw-retained (on Ti-base), custom ZrO2 abutment retained all-ceramic restoration with hand-built-up supramucosal veneering

Вмешательства

Устройство CAD/CAM custom ZrO2 healing abutment
Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.
Устройство Cylindrical ZrO2 healing abutment
Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.

Первичные конечные точки

midfacial keratinized mucosa volume [Срок оценки: 4, 12, 36 months post op.]
midfacial keratinized mucosa width [Срок оценки: 4, 12, 36 months post op.]
Keratinized mucosa thickness [Срок оценки: before implantation, 4,12, 36 months post op.]

Вторичные конечные точки (10)

soft tissue volume [Срок оценки: 4, 12, 36 months post op.]
laser speckle contrast imaging (LSCI) [Срок оценки: at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation]
ultrasound [Срок оценки: at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation]
marginal bone loss [Срок оценки: 4, 12, 36 months post op.]
Implant survival [Срок оценки: 4, 12, 36 months]
full mouth plaque score (FMPS) [Срок оценки: 0., 1., 7., 14. day, and 1., 2., 4., 6., 12., 36. month after implantation]
full mouth bleeding score (FMBS) [Срок оценки: 0. day, and 4., 12., 36. month after implantation]
Probing depth (PPD) [Срок оценки: 0., 4., 12., 36. month after implantation]
Functional implant prosthodontic score (FIPS) [Срок оценки: 4 months after implantation, at final restoration delivery]
Pain at delivery [Срок оценки: 4 months after implantation, at final restoration delivery]

Критерии участия

Критерии включения

patients over 18 years
good general health
good oral hygiene (FMPS < 25%)
healthy periodontium (PPD < 4mm)
thick phenotype
maxilla anterior region (extended to 15-25 positions)
solo missing teeth, intact adjacent teeth
type 1 alveolar shape after extraction 1
retained occlusion
baseline buccal bone wall thickness at least 1.5 mm, based on intact CBCT scan
patient voluntarily accepts and signs the information and consent form for the study