Active Oxygen Releasing Gel With Photodynamic Therapy in Treating Stage III Periodontitis

Официальное название

Evaluation of Active Oxygen Releasing Gel Combined With Photodynamic Therapy in The Treatment of Stage III Periodontitis (A Randomized Controlled Clinical Trial)

Обзор

Periodontitis is a serious gum disease that can damage the tissues supporting the teeth. The standard treatment is scaling and root planing of the teeth and roots. However, in some patients, this treatment alone may not fully control inflammation and harmful bacteria. This study aims to evaluate whether adding an active oxygen-releasing gel, with or without photodynamic therapy, improves treatment outcomes in patients with stage III periodontitis. The oxygen-releasing gel is applied to the gums and releases oxygen, which may help reduce harmful bacteria. Photodynamic therapy uses a light source together with a special dye to target and destroy bacteria and improve gingival health. In this randomized clinical trial, 42 patients with stage III periodontitis will be divided into three groups. One group will receive standard scaling and root planing (SRP) plus the oxygen-releasing gel. A second group will receive standard scaling and root planing (SRP)plus the gel and photodynamic therapy. The third group will receive standard scaling and root planing(SRP) only. Gum health will be evaluated by measuring gingival index, bleeding index, pocket depth, and supra crestal tissue attachment level at the start of the study and after one and three months. Microbiological samples from periodontal pockets will also be used to assess levels using quantitative Polymerase Chain Reaction (qPCR) for relative abundance of Treponema denticola and Porphyromonas gingivalis bacteria related to periodontal disease.

Вмешательства

• Процедура Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laser
  14 stage III periodontitis patients will undergo scaling and root planing in a single session followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes then irrigating the targeted pocket using tolonium chloride will be stopped once the tolonium chloride solution will be observed at the free gingival margin of the pocket. After 60 seconds, irradiation inside the periodontal pocket with diode laser (635nm) for 200 mW, 30 seconds, energy density of 6 J/cm2, tip diameter
• Процедура Scaling and root planing and topical application of active oxygen-releasing gel
  14 patients with stage III periodontitis will undergo scaling and root planing in a single session followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes.
• Процедура Scaling and root planing
  14 patients will undergo scaling and root planing(SRP) using ultrasonics and Gracey curettes.

Первичные конечные точки

• Modified Gingival Index (MGI) score [Срок оценки: Before enrollment, and one and three months after enrollment]
• Percentage of sites with Bleeding on Probing (BOP) assessed by a periodontal probe [Срок оценки: Before enrollment, and one and three months after enrollment]
• Measurement of Clinical Attachment Level (CAL) using a Williams calibrated periodontal probe [Срок оценки: Before enrollment, and one and three months after enrollment]
• Probing Pocket Depth (PPD) in millimeters measured by Williams periodontal probe [Срок оценки: Before enrollment, and one and three months after enrollment]

Вторичные конечные точки (1)

• Relative abundance of Treponema denticola and Porphyromonas gingivalis using quantitative Polymerase Chain Reaction (qPCR) [Срок оценки: Before enrollment and one month after enrollment]

Критерии участия

Критерии включения

• Patients with periodontal diagnosis of stage III periodontitis
• Patients with residual periodontal pocket depth ≥4 mm ,CAL≥ 5mm with bone loss extending to middle third of root and beyond in radiography
• Bleeding on probing at least four sites at base-line
• Patients who didn't receive periodontal treatment for a minimum of 3 months prior to the examination.
• Patients of both sexes aged ≥30 and ≤70 years

Критерии исключения

• Smokers or those with any other harmful habits such as pipe or vape smoking
• Patients with any systemic condition that will possibly affect the outcome of periodontal therapy i.e. (diabetic patients)
• Patients who have received any local or systemic anti-inflammatory medications or antibiotics within the last 6 months
• Pregnant or lactating women
• Patients with parafunctional habits

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

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dentistry, Alexandria University — Alexandria

Идентификаторы

NCT: NCT07368699 · 1016-12/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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