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Идёт набор NCT06656325

An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis

Без фазы С лечением Periodontal Diseases Periodontitis Gum Disease

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: Erchonia® FX405, Placebo Laser.
Кому может быть актуально
Состояния в реестре: Periodontal Diseases, Periodontitis, Gum Disease. Базовые параметры: 22 лет — 75 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

An Evaluation of the Effect of the Erchonia Corporation FX-405 Laser as an Adjunctive Treatment of Periodontitis

Обзор

The purpose of this clinical study is to determine the effectiveness of the Erchonia® FX-405 (manufactured by Erchonia Corporation (the Company) in providing a noninvasive adjunctive treatment in combination with periodontal scaling and root planing for improving the treatment of periodontal disease.

Подробное описание

The purpose of this clinical study is to determine the effectiveness of the Erchonia® FX-405 (manufactured by Erchonia Corporation (the Company) in providing a noninvasive adjunctive treatment in combination with periodontal scaling and root planing for improving the treatment of periodontal disease. This clinical study is a double-blind design, such that neither the subject, nor the investigators - the investigator administering the treatment with the Erchonia® FX-405™ device (administration investigator) or the investigator recording the outcome measures (assessment investigator) - will be aware of whether the subject has been assigned to the active treatment test group or to the sham treatment control group until after the study is complete. All study subjects, regardless of treatment group assignment will receive active scaling and root planing standard of care therapy in addition to the active or sham therapy with the Erchonia® FX-405™ device.

Вмешательства

  • Устройство Erchonia® FX405
    Procedure administrations with the Erchonia® FX-405 will be applied eight times during the 5-month procedure administration phase. Phase One involves one procedure administration each week for 4 consecutive weeks. Phase 2 commences for one month following the completion of Phase One and involves one procedure administration each month for the next four consecutive months. Each procedure administration with the Erchonia FX405 takes 10 minutes and will be administered by the test site. Additional
  • Устройство Placebo Laser
    Procedure administration with the Placebo Laser (emitting non therapeutic light) will be applied eight times during the 5-month procedure administration phase. Phase One involves one procedure administration each week for 4 consecutive weeks. Phase 2 commences for one month following the completion of Phase One and involves one procedure administration each month for the next four consecutive months. Each procedure administration with the Placebo Laser takes 10 minutes and will be administered b

Первичные конечные точки

  • Number of participants with a change in Clinical Attachment Loss of ≥-2mm at the primary tooth assessment site [Срок оценки: Baseline and 8 months]

Критерии участия

Критерии включения

  • Subject has voluntarily signed a written informed consent form.
  • Male or female 22 to 75 years of age, inclusive.
  • Subject has no evidence of Localized Aggressive Periodontitis.
  • Tooth loss due to periodontitis of ≤ 4 teeth.
  • Two or more teeth with the following characteristics: Non 3rd molar, Periodontitis: Stage III (Severity) according to the Interdental CAL (at site of greatest loss) and RBL, as classified by the American Academy of Periodontology (AAP), No evidence of caries, No abscess infection, No previous periodontal surgery within the prior 12 months
  • Subject agrees to adhere to study provided home care instructions to maintain adequate oral hygiene during the study duration.
  • Subject agrees to refrain from the use of smokeless chewing tobacco for the study duration.
  • Subject agrees to refrain from exceeding 40 milligrams per day of inhaled nicotine, encompassing cigarettes, electronic cigarettes, and cigars.
  • Subject agrees to refrain from engaging in any other treatments for his or her periodontitis that is outside the scope of this study during his or her participation in this study

Критерии исключения

  • Gingival recession which may be genetic, induced secondary to orthodontic treatment, induced secondary to frenulum attachments, or present as a result of dental malocclusion.
  • History of oral cancer or HIV in the last 6 months
  • Pregnant or intending to become pregnant in the next 8 months.
  • Sensitivity to, or contraindication for, light therapy.
  • Currently enrolled in a clinical study of an investigational drug or device.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • 805 Dentistry — Thousand Oaks
  • Acton Dental Associates — Acton

Идентификаторы

NCT: NCT06656325 · R-GUM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗