Голландские ученые Ян В. В. ван Дийкен (Jan W.V. van Dijken) и Улла Паллесен (Ulla Pallesen) недавно завершили свое длительное (шестилетнее) рандомизированное исследование эквивалентности, которое проводилось с целью оценки длительного клинического эффекта нового нано-гибридного композитного материала второго класса пломбирования посредством внутрииндивидуального сравнения с традиционным хорошо зарекомендовавшим себя гибридным композитом-предшественником.
В исследовании участвовали 52 человека, которые имели две замененных пломбы второго класса, при этом большая часть выполненного пломбирования была идентичной. Полости для пломбирования были выбраны случайным образом как для использования традиционного материала, так и для применения нового. Выполненная работа была оценена посредством слегка измененных критериев USPHS в начале исследования и далее ежегодно в течение шести лет.
Результаты исследования включали четыре выпавших пломбы у двух пациентов во время ежегодной проверки; проведенная ранее оценка выявила высокий риск развития кариеса у 16 из 52 пациентов. В целом, за шесть лет выпали или сломались восемь нано-гибридных и шесть традиционных пломб; главной причиной проблем с пломбой был вторичный кариес, уровень которого составил 43%. При этом 60% вторичного кариеса были обнаружены у пациентов с высоким риском его развития. В целом уровень успешности пломбирования за шесть лет составил 88,1%; также не было отмечено существенной разницы в сроке годности между двумя типами исследуемого композитного материала.
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