Меню
Идёт набор NCT04766255

Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.

Фаза IV С лечением Soft Tissue Atrophy Mucogingival Deformity on Edentulous Ridge Edentulous Alveolar Ridge

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: Soft Tissue graft augmentation, Implant Placement.
Кому может быть актуально
Состояния в реестре: Soft Tissue Atrophy, Mucogingival Deformity on Edentulous Ridge, Edentulous Alveolar Ridge. 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants in Terms of Volume Gain and Stability Over Time: A Randomized Clinical Trial.

Обзор

The purpose of the study is to compare soft tissue volume changes in terms of volume gain and stability around dental implants and PROMS in cases where a sub-epithelial connective tissue graft (SCTG) from the palate, Porcine collagen matrix (CM) or Porcine Acellular dermal matrix (PADM) is used after 3 and 15 months after implant placement.

Вмешательства

  • Процедура Soft Tissue graft augmentation
    Donor site: SCTG group: The SCTG will be harvested in the palat,In order to extract the same thickness in each grafts a double-bladed knife (separated by 1,5mm) will be used. The donor area will be sutured. Recipient site: SCTG group: the connective tissue graft will be trimmed to the correct dimensions (10mm height, 12mm length and 1,5mm thick) and placed and secured at the recipient site with a resorbable 5-0 suture CM group: The CM graft (Geistlich Fibro-gide) will be trimmed to the indica
  • Процедура Implant Placement
    A crestal incision will be made in the implant reception area, extending from the distal of the most mesial tooth to the mesial of the most distal tooth. A mucoperiosteal flap will be elevated in the most crestal part of the ridge. The receptor bed will be prepared following the established drilling protocol for the placement of a BioHorizons Tapered Pro Implant (Biohorizons, Birmingham AL). The diameter and length of the implant will be previously established during the implant study. Later a h

Первичные конечные точки

  • soft tissue volume gain [Срок оценки: after 3 months]
Вторичные конечные точки (8)
  • soft tissue volume stability [Срок оценки: after 15 months]
  • Plaque index (PI) [Срок оценки: at baseline, after 12 weeks and after 15 months.]
  • Bleeding on probing (BI) [Срок оценки: at baseline, after 12 weeks and after 15 months.]
  • Probing depth (PD) [Срок оценки: at baseline, after 12 weeks and after 15 months.]
  • Width of keratinized tissue (KT) [Срок оценки: at baseline, after 12 weeks and after 15 months.]
  • Phenotype evaluation (PT) [Срок оценки: at baseline, after 12 weeks and after 15 months.]
  • Patient reported outcome measures (PROMs) [Срок оценки: after the surgery procedures (baseline) and after 7 days (suture removal)]
  • Pink Esthetic Score (PES) [Срок оценки: After 2 weeks of the definite crown placement (around 16 months)]

Критерии участия

Критерии включения

Patients referred to Department of Periodontology (CUO) in need of a single implant and need of soft tissue augmentation such as buccal defects, thin biotype, lack of keratinized tissue and aesthetic compromised situation.

  • The patient must be ≥18 years and able to understand the nature of the proposed surgery and must sign an informed consent.
  • The implant must be located between 2 fixed reference points (i.e. clinical crowns).
  • Anterior and premolar teeth (from premolar to premolar).
  • Enough crestal bone width to leave a minimum thickness of 2mm at the buccal bone plate when placing the implant.
  • Palate must have ≥2mm of thickness at premolar area.
  • Full mouth plaque and bleeding score <20%.

Критерии исключения

  • Pregnant or lactation.
  • Active periodontal disease.
  • Previous soft tissue augmentation in the area.
  • Need of guided bone regeneration (GBR) during or after the placement of the implant.
  • Heavy smokers (> 10 cigarettes per day).
  • Local or systemic conditions that would interfere with routine periodontal therapy (non-controlled diabetes mellitus, cancer, HIV, Chronic High dose steroid therapy, bone metabolic diseases, radiation, immunosuppressive disorders, liver function disorder, immunosuppressant disease, autoimmune disease).
  • Allergy to non-steroidal anti-inflammatory drugs.
  • Patients taking medications that cause gingival enlargement.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Universitat Internacional de Catalunya — Sant Cugat del Vallès

Идентификаторы

NCT: NCT04766255 · PER-ECL-2017-07

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗