Immediate Implant Provisionalization

Официальное название

Soft Tissue Stability of Immediate Implant Placement With and Without Immediate Provisionalization: A Randomized Controlled Clinical Trial

Обзор

This research is studying gum tissue stability of dental implants placed at same appointment as the tooth extraction, with or without a provisional (temporary) crown.

Подробное описание

This study aims to find out whether a new type of hybrid dental implant-which has a smooth surface near the gums to make cleaning easier and potentially lower the risk of infection-can help improve gum health and reduce implant complications. It also compares two common treatment approaches after tooth removal: placing a temporary provisional crown immediately versus using a standard healing cap. By studying these options, we hope to learn which method provides better healing, protects the gums more effectively, and leads to fewer problems around the implant.

Вмешательства

• Устройство Dental implant placement
  A dental implant will be placed after tooth extraction.

Первичные конечные точки

• Linear changes of gum tissue architecture [Срок оценки: 1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery]
• Volumetric changes of gum tissue architecture [Срок оценки: 1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery]

Вторичные конечные точки (3)

• Changes in marginal bone [Срок оценки: 5 months after baseline surgery, 6 months and 12 months after crown delivery]
• Patient-reported satisfaction [Срок оценки: 14 days after baseline surgery]
• Microbial profile [Срок оценки: Baseline, 4 months after baseline surgery, 6 months and 12 months after crown delivery]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
• Periodontally healthy or with treated periodontitis with good oral hygiene ((FMPS) and (FMBS) ≤15%, measured at four sites per tooth).
• Presence of one non-restorable maxillary anterior tooth (from #5 to #12 sites)
• More than 20 occluding teeth with stable occlusion.
• Nonsmokers or smokers < 10 cig/day (self-reported).

Критерии исключения

• Presence of uncontrolled or untreated periodontal disease.
• Presence of active periapical infection.
• Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c > 8)).
• Pregnant subjects or individuals attempting to get pregnant (self-reported)
• Subjects smoking 10 or more cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)
• Subjects unable to maintain adequate oral hygiene
• Insufficient restorative space or bite collapse.
• Lack of primary implant stability assessed intrasurgically.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan School of Dentistry — Ann Arbor

Идентификаторы

NCT: NCT07732647 · HUM00275903

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗