Идёт набор NCT07282756

Evaluation Of The Efficacy Of Subgingival Application Of Lovastatin Gel As An Adjunct To Non-Surgical Treatment Of Periodontitis In Generally Healthy Smokers And Non-Smokers Patients in Central Europe.

Без фазы С лечением Periodontal Diseases Periodontitis Periodontal Disease Smokers

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: Subgingival application of 1.2% lovastatin, Subgingival application of placebo gel.
Кому может быть актуально: Состояния в реестре: Periodontal Diseases, Periodontitis, Periodontal Disease, Smokers. Базовые параметры: 18 лет — 59 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: Польша
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

Assessment of Changes in Clinical and Radiological Parameters in Gingival Pockets After Subgingival Application of Lovastatin Gel in Combination With SRP Procedure Compared to SRP and Placebo Gel Application in the Treatment of Periodontal Disease in Generally Healthy Non-smokers and Smokers From Central Europe: a Split-mouth Randomized Controlled Trial.

Обзор

The aim of the study is to evaluate how a gel (1.2% lovastatin) applied under the gum improves the results of classic periodontal treatment (SRP-scaling, root planing). The study involves two groups of adults diagnosed with periodontitis: the first group consists of generally healthy individuals who do not smoke tobacco. The second group consists of generally healthy individuals who have been smoking for at least 5 years. Before the study begins, each participant will undergo gum health measurements. Changes in these parameters will be monitored throughout the study. Two teeth will be selected for each participant: * a gel containing the medication will be applied under the gum of one tooth * a gel that looks similar to the medication but does not contain any medicinal substance will be applied under the gum of the second tooth. Before applying the gel, each participant will undergo subgingival cleaning (SRP) to remove any debris that may prevent the medicine from working. The study will last six months. Expected results: * all participants will experience an improvement in the condition of their gums after treatment * the effect of treatment will be better in non-smokers than in smokers * the treatment outcome will be better in the area where the medicated gel was applied compared to areas where the gel without medicinal substances was applied.

Вмешательства

Препарат Subgingival application of 1.2% lovastatin
Each patient will be assigned 2 sites that meet the inclusion criteria. After the SRP (scaling, root planing) procedure is applied within the qualified gingival pockets, a gel drug (1.2% concentration of lovastatin) will be applied to one site selected by randomization.
Препарат Subgingival application of placebo gel
Each patient will be assigned 2 sites that meet inclusion criteria. After the SRP procedure (scaling, root planing) procedure is applied within qualified gingival pockets, placebo gel will be applied to one site selected by randomization.

Первичные конечные точки

Clinical Attachment Level [Срок оценки: change from baseline to 6 months after intervention]
Probing Depth [Срок оценки: change from baseline to 6 months after intervention]
modified Sulcus Bleeding Index (mSBI) [Срок оценки: from baseline to six months after intervention]
Plaque Index Pl.I. (Silness i Löe) [Срок оценки: from baseline to 6 months after intervention]

Вторичные конечные точки (1)

Infrabony Defect Depth [Срок оценки: from baseline to six months after intervention]

Критерии участия

Критерии включения

generally healthy patients
diagnosed periodontal disease (at least one pair of non-adjacent sites with PD≥5 mm or CAL ≥4 mm and vertical bone loss ≥ 3 mm)
no history of periodontal disease treatment
no history of antibiotic use in the past 6 months
an eligible tooth must be alive, with no history of endodontic treatment
non-smoking (group I) or active smokers (group 2)