Evaluation of Active Oxygen Releasing Gel Combined With Photodynamic Therapy in The Treatment of Stage III Periodontitis (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Modified Gingival Index (MGI) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study is open-label for participants and clinicians due to the nature of the interventions. However, to ensure objectivity, the trial statistician and the microbiologist performing the laboratory analysis will remain masked to treatment assignment (blinded) until the final data analysis is complete. Samples sent to the microbiology lab will be coded with unique identification numbers to maintain blinding.
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SRP+ Oxygen gel+Laser
Scaling and root planing (SRP) will be performed in a single session, followed by the topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes. Subsequently, antimicrobial Photodynamic Therapy (aPDT) will be applied using a diode laser (635 nm) with tolonium chloride as a photosensitizer. The laser irradiation will be performed at an energy density of 6 J/cm2 for 30 seconds per site."
干预措施: Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laser (Procedure)
SRP+ Oxygen gel+Laser
Scaling and root planing (SRP) will be performed in a single session, followed by the topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes. Subsequently, antimicrobial Photodynamic Therapy (aPDT) will be applied using a diode laser (635 nm) with tolonium chloride as a photosensitizer. The laser irradiation will be performed at an energy density of 6 J/cm2 for 30 seconds per site."
干预措施: Scaling and root planing (Procedure)
SRP+Active oxygen gel.
Scaling and root planing(SRP)followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minute
干预措施: Scaling and root planing and topical application of active oxygen-releasing gel (Procedure)
SRP+Active oxygen gel.
Scaling and root planing(SRP)followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minute
干预措施: Scaling and root planing (Procedure)
SRP+ Oxygen gel+Laser
Scaling and root planing (SRP) will be performed in a single session, followed by the topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes. Subsequently, antimicrobial Photodynamic Therapy (aPDT) will be applied using a diode laser (635 nm) with tolonium chloride as a photosensitizer. The laser irradiation will be performed at an energy density of 6 J/cm2 for 30 seconds per site."
干预措施: Scaling and root planing and topical application of active oxygen-releasing gel (Procedure)
Scaling and root planing alone.
Scaling and root planing using ultrasonics and Gracey curettes.
干预措施: Scaling and root planing (Procedure)
结局指标
主要结局
Modified Gingival Index (MGI) score
时间窗: Before enrollment, and one and three months after enrollment
non-invasive, visual clinical tool (0-4 scale)focuses on color, texture, and contour changes across facial, lingual, mesial, and distal surfaces of tooth ,modified gingival Scoring Criteria for MGI (0-4) higher scores indicate more severe gingival inflammation higher a worse clinical outcome. 0: Absence of inflammation (normal gingiva). 1. Mild inflammation - slight change in color/texture in part of the marginal or papillary gingiva. 2. Mild inflammation - slight change in color/texture in the entire marginal or papillary gingiva. 3. Moderate inflammation - bright surface, erythema, edema, and/or hypertrophy of the marginal or papillary gingiva. 4. Severe inflammation - severe erythema, edema, and/or marg
Percentage of sites with Bleeding on Probing (BOP) assessed by a periodontal probe
时间窗: Before enrollment, and one and three months after enrollment
a clinical parameter measured by inserting a periodontal probe to the base of a gingival pocket.The probe is inserted parallel to the root surface and "walked" around the gingival sulcus, with bleeding assessed 30-60 seconds after probing.recorded as a percentage of positive bleeding sites out of the total sites probed (6 sites per tooth). A higher percentage of bleeding sites indicates increased gingival inflammation and a worse outcome.
Measurement of Clinical Attachment Level (CAL) using a Williams calibrated periodontal probe
时间窗: Before enrollment, and one and three months after enrollment
measured in millimeters using Williams calibrated probe from the cemento-enamel junction to the bottom of the pocket .This measure reflects the extent of periodontal tissue destruction. Higher values in millimeters indicate greater attachment loss and a worse clinical condition.
Probing Pocket Depth (PPD) in millimeters measured by Williams periodontal probe
时间窗: Before enrollment, and one and three months after enrollment
Clinical measurement of the distance in millimeter from the gingival margin to the base of the periodontal pocket using Williams calibrated probe.Deeper pockets indicate more severe periodontal disease. Higher values represent a worse outcome.
次要结局
- Relative abundance of Treponema denticola and Porphyromonas gingivalis using quantitative Polymerase Chain Reaction (qPCR)(Before enrollment and one month after enrollment)
研究者
Aya Abdelmawla
Periodontology resident at periodontology department Alexandria University,Egypt
Alexandria University