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Набор скоро начнётся NCT06799871

RFA R-Evolution: a New Protocol to Avoid Implant Failure

— Наблюдательное 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: Dental implant.
Кому может быть актуально
Состояния в реестре: 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
Список центров уточняется — проверьте первичный протокол.
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

Retrospective Single Cohort Mono-center Study on Trends in Implant Stability Measured by RFA

Обзор

The main objective of this study is to assess the impact of confounding factors such as jaw, implant position, indication, smoking status, implant dimension, and medical history on RFA trends. In addition, this study aims to explore correlations of RFA trend, with the goal of using ISQ trends as an indicator for treatment protocol decisions (e.g. time of loading). Participants have already received dental implant as per clinic's standard protocol. Information regarding Implant Stability Quotient (ISQ) measurements performed at any time point until 1-year follow-up will be collected. The principal investigator protocol regarding the use of ISQ measure to define time of implant loading will also be assessed. Only participants followed up at least until one year after implant placement will be included in the data collection.

Подробное описание

This single-center retrospective study includes all consecutive participants treated since October 2021 for single or multiple edentulous sites (either healed or extracted). Only participants with a 1-year follow-up visit and RFA measurements at three or more time-points are included.

Participants will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria. As the data is anonymized, participants will not be contacted for consent.

Any additional post-hoc exclusion of participants will be thoroughly documented.

The primary endpoint of the study is:

-Occurrence of RFA trends (3 consecutive increasing or stable RFA values vs 3 consecutive decreasing RFA values)

Secondary endpoints:

* Implant treatment success (implant loaded functionally) after 1 year of implant placement * Change in prosthetic protocol (3 months to definitive prosthesis placement in maxilla, 2 months in mandible) due to ISQ trend

Participants have already received dental implant(s) at surgery visit. Implant Stability Quotient (ISQ) was assessed after implant placement. Depending on the trends in ISQ, implants were loaded with provisional and the final prosthesis and followed up at least until 1 year after surgery.

Data collection methods Data will be collected by automatic extraction from the clinic's patient management system and will for statistical analysis.

Implant is considered survived if it is in-situ. Implant treatment success is defined as implant loaded functionally.

Demographic data will be collected in the automatic extraction of the data and used to access participant's eligibility to partake in the study.

Any relevant medical history of participants will be collected in the automatic extraction as well. Demographic and medical history data will also be part of the data analysis.

At interim and 1-year follow-up visits, prosthetic parameters will be collected.

Вмешательства

  • Устройство Dental implant
    There is no intervention in the study. The participants have already received dental implant treatment and data will be collected retrospectively regarding the procedure

Первичные конечные точки

  • Resonance frequency analysis (RFA) trends [Срок оценки: From implant insertion until definitive prosthesis delivery (3 months after implant insertion). Time duration 3 months]
Вторичные конечные точки (2)
  • Implant treatment success [Срок оценки: Until 1 year after implant insertion]
  • Change in prosthetic protocol [Срок оценки: Until 1 year after implant insertion]

Критерии участия

Критерии включения

  • Participant received implant treatment NobelReplace, NobelActive or NobelParallel implants on or after October 2021 (with TiUnite or TiUltra surfaces)
  • Participant was at least 18 years old at the time of surgery
  • Participant attended a follow-up visit at least 1-year after surgery
  • Implant stability was assessed by means of RFA at a minimum of three time-points

Критерии исключения

  • 1-year follow-up data not available
  • Subject received major guided bone regeneration

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06799871 · 2024-1806

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗