Adjunctive Antioxidant Effect of Centella Asiatica Nanoemulsion Gel in the Management of Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Plaque Index
研究概览
简要总结
The aims of the current study are:
- Evaluation of the clinical efficacy of local delivery of nanoemulsion gel containing Centella asiatica extract as an adjunct to conventional non-surgical periodontal therapy in periodontitis patients.
- Evaluation of the antioxidant effect of this treatment by the assessment of nuclear factor erythroid 2-related factor 2 (NrF2) and glutathione peroxidase 1 (GPX1) in the gingival crevicular fluid (GCF) samples.
详细描述
Forty-five healthy patients with periodontitis and healthy subjects with healthy periodontium will be included in the current study. At the beginning of the treatment, all selected patients will be motivated about the benefit of plaque control and periodontal prophylaxis.
The participants will be selected from the Outpatient Clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University. The patients will be informed about the treatment that they will receive and steps that will be taken. This includes the possible effects or risks and other treatment options according to the rules of the ethical committee of the Faculty of Dentistry, Mansoura University. The subjects must understand this explanation in broad terms. They must be legally competent to give written consent before performing any required steps. The research protocol will be presented to the ethical committee at the Faculty of Dentistry, Mansoura University, to get its approval.
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
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 25-55 years, either sex
- •Diagnosis of periodontal health OR Stage III periodontitis (per 2017 World Workshop Classification)
排除标准
- •Known allergy or sensitivity to any component of the study medication
- •Systemic antibiotics or anti-inflammatory medications within the preceding 6 months
- •Uncontrolled diabetes mellitus
- •Cardiovascular disease
- •Rheumatoid arthritis
- •Renal disease
- •Pulmonary disease
- •Thyroid disease
- •Malignancy
- •Current smokers
- •Pregnant or lactating women
- •Unable or unwilling to comply with prescribed oral hygiene instructions
研究组 & 干预措施
group I treated with C. asiatica nanoemulsion as an adjunct to SRP
Group I (study group): 15 Patients with periodontitis Stage III will be treated with C. asiatica nanoemulsion as an adjunct to SRP.
干预措施: Centella asiatica nanoemulsion gel (Drug)
group I treated with C. asiatica nanoemulsion as an adjunct to SRP
Group I (study group): 15 Patients with periodontitis Stage III will be treated with C. asiatica nanoemulsion as an adjunct to SRP.
干预措施: Scaling and Root Planing (SRP) (Procedure)
Group II (positive control group) treated with SRP
Group II (positive control): 15 patients with periodontitis Stage III will be treated with scaling and root planing (SRP) alone, with no adjunctive gel application.
干预措施: Scaling and Root Planing (SRP) (Procedure)
Group III (negative control group): no intervention
Group III (negative control/healthy control): 15 periodontally healthy participants who will receive no active periodontal intervention; assessed at baseline only
结局指标
主要结局
Plaque Index
时间窗: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Full-mouth plaque accumulation scored at the mesial, distal, buccal, and lingual/palatal surfaces of each examined tooth on a 0-3 scale, with higher scores indicating greater plaque accumulation. The participant-level score is the average of all recorded surface scores.
Gingival Index
时间窗: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Gingival inflammation was scored at each examined surface on a 0-3 scale based on gingival color, consistency, and presence/absence of bleeding on probing, with higher scores indicating more severe inflammation (0 = clinically healthy gingiva, 3 = severe inflammation with marked redness, edema, ulceration, or spontaneous bleeding).
Gingival Bleeding Index
时间窗: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Presence or absence of bleeding recorded following gentle probing of the gingival margin at each examined site, calculated as the number of bleeding sites divided by the total number of examined sites and expressed as a percentage. Higher percentages indicate greater gingival bleeding.
Periodontal Probing Depth (PPD)
时间窗: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Distance in millimeters from the free gingival margin to the base of the periodontal pocket, measured at multiple sites per tooth using a calibrated periodontal probe. Higher values indicate deeper pockets and greater periodontal destruction.
Clinical Attachment Level (CAL)
时间窗: Baseline and 3 months (Groups 1 and 2); baseline only (Group 3)
Distance in millimeters from the cemento-enamel junction to the base of the periodontal pocket, measured at multiple sites per tooth using a calibrated periodontal probe. Higher values indicate greater loss of periodontal attachment
次要结局
未报告次要终点