Идёт набор NCT07053969

The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness

Без фазы С лечением Dental Implantation Missing Teeth Periodontitis, Adult Mucositis

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: Enamel Matrix Derivative.
Кому может быть актуально: Состояния в реестре: Dental Implantation, Missing Teeth, Periodontitis, Adult, Mucositis. Базовые параметры: 18 лет — 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: США
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

The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness. A Randomized Controlled Trial.

Обзор

Scientists do research to answer important questions which might help change or improve the way we do things in the future. The investigators know that using Enamel Matrix Derivatives results in thicker gum tissues around teeth. This study will test to see if using EMD around implants results in thicker gum tissues around implants.

Подробное описание

The hypothesis of the study is that the addition of EMD under the gingival flap prior to suturing will result in increased mucosal tissue thickness and increased keratinized tissue width as compared to not using the EMD.

The EMD will be deposited under the mucosal flap during the second stage implant uncovering. After flap suturing, an intraoral scan will be obtained. This procedure will require approximately 5 - 10 minutes per patient. All patients will be followed up at 14 days for suture removal per standard of care and not as part of the study. All patients will be followed up at one and three months per standard of care during which visits they will undergo an intraoral scan to allow evaluation of soft tissue dimensions. This is research only procedure that is expected to add 5 - 10 minutes to the regular postoperative visit. Study participation will be completed at the 3-month visit.

Вмешательства

Устройство Enamel Matrix Derivative
EMD is an FDA approved medical device used in periodontal procedures since 1996. It has been shown to enhance soft and hard tissue healing, increased root coverage and aid in periodontal regeneration. It's use as an adjunct during implant uncovering may increase peri-implant mucosal thickness.

Первичные конечные точки

Mucosal Thickness [Срок оценки: One month and 3 months]
Change in Keratinized mucosal width [Срок оценки: One month and 3 months]

Критерии участия

Критерии включения

Ability of subject to understand and the willingness to sign a written informed consent document.
Males and females; Age 18 to 89 years old
Require second stage implant uncovering
In either the maxillary or mandibular arch
Has consistent transportation for all clinical and study visits