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Идёт набор NCT07509281

Peri-implant Tissues Changes for Different Abutment Shapes and Heights

Без фазы С лечением Dental Implant-Abutment Designs Marginal Bone Loss in Different Abutment Designs Soft Tissue Management in Subcrestal Dental Implants

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: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol.
Кому может быть актуально
Состояния в реестре: Dental Implant-Abutment Designs, Marginal Bone Loss in Different Abutment Designs, Soft Tissue Management in Subcrestal Dental Implants. 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 →

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Официальное название

Influence of Supracrestal Soft Tissue on Peri-implant Bone Changes for Different Abutment Shapes and Heights: A Four-Arm Randomized Clinical Trial

Обзор

The goal of this randomized clinical trial is to investigate the influence of supracrestal soft tissue on abutments of different heights (2-mm vs. 3-mm) and shapes (cylindrical abutment vs. concave abutment) on changes in the marginal bone level (bone loss and bone remodeling) in healthy, partially edentulous volunteer patients undergoing implant-supported rehabilitation. The main questions it aims to answer are: * Is there any difference in marginal bone loss for different abutment shapes and heights? * Do the shape and height of the abutment affect implant success? All participants will receive bone-level dental implants placed approximately 2-mm below the bone crest, each receiving a different type of abutment and researchers will see whether the shape and height of the abutment influence the success of the implant, periodontal probing depth (PPD), and bleeding on probing (BoP) comparing four groups of patients: 1. 2-mm high abutments with cylindrical shape. 2. 2-mm high abutments with concave shape. 3. 3-mm high abutments with cylindrical shape. 4. 3-mm high abutments with concave shape. Clinical and radiographic assessments will be performed at abutment placement, at definitive prosthesis placement, and at 1, 3, 6, and 12 months after loading to measure marginal bone loss and peri-implant parameters.

Вмешательства

  • Процедура Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol
    Participants will receive bone-level dental implants placed approximately 2 mm below the bone crest in a healed posterior site of the maxilla or mandible. The implants will be placed using biological drilling protocol and inserted with a final torque of at least 35 Ncm following the manufacturer's instructions . A transmucosal abutment according to the applicable randomization will be connected at the time of surgery with a final torque of at least 30 Ncm, following the "one abutment-one time" p

Первичные конечные точки

  • Changes in peri-implant marginal bone level (mm) [Срок оценки: From abutment placement (baseline time [TB]), 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) after definitive prosthesis placement.]
Вторичные конечные точки (3)
  • Peri-implant probing depth (mm) [Срок оценки: 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) after definitive prosthesis placement.]
  • Bleeding on probing (presence/absence) [Срок оценки: 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) after definitive prosthesis placement.]
  • Implant success [Срок оценки: From the time of surgery through the end of the 12-month follow-up period after definitive prosthesis placement.]

Критерии участия

Критерии включения

  • Adults aged 18 years or older.
  • Posterior edentulism (premolars/molars).
  • Good general and oral health, with controlled plaque and bleeding indices.
  • Sufficient bone height and width for implant placement without the need for bone regeneration procedures. Patients who require indirect sinus lift procedure simultaneously with implant placement may be included in the study.
  • Presence of at least 2 mm of keratinized mucosa around the dental implant.
  • Stable occlusion and healthy periodontium.
  • Insertion torque ≥ 35 Ncm at the time of implant placement.
  • Willingness to comply with study protocol and attend scheduled follow-up visits.

Критерии исключения

  • Presence of medical conditions that contraindicate implant surgery, such as heavy smoking (>10 cigarettes per day), severe bruxism, pregnancy or breastfeeding, bisphosphonate therapy, and patients undergoing chemotherapy or radiotherapy in the head and/or neck area.
  • Active periodontal disease or peri-implant infection.
  • Uncooperative patients or patients unable to complete follow- up.
  • Implant failures.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Universitat de València — Valencia

Идентификаторы

NCT: NCT07509281 · UV-INV-ETICA-3792382

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗