The Efficacy of Non-surgical Periodontal Therapy in Combination With Aspirin and Omega-3 Fatty Acids.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Gingival Index (GI)
研究概览
简要总结
The goal of this clinical trial is to learn if non-surgical periodontal treatment combined with Omega-3 fatty acids and Aspirin can improve clinical outcomes and biochemical markers in patients with periodontitis. The main questions it aims to answer are:
Does the combination of Omega-3 and low-dose Aspirin significantly change the concentration of biochemical and immunological markers such as Interleukin-6 (IL-6) and C-reactive protein (CRP) in serum?
Is the combination of Omega-3 and Aspirin more effective than Omega-3 alone or standard non-surgical treatment in treating periodontitis?
Researchers will compare three groups:
Control group: Scaling and root planing (SRP) only.
Intervention group 1: SRP combined with Omega-3 fatty acids.
Intervention group 2: SRP combined with Omega-3 fatty acids and 81mg Aspirin.
The comparison aims to see if the combined therapy (Intervention group 2) provides superior anti-inflammatory effects and better clinical healing compared to the other groups.
Participants will:
Undergo clinical screening and selection based on study criteria.
Be randomly assigned to one of the three treatment arms.
Receive non-surgical periodontal treatment (scaling and root planing).
Take prescribed supplements (Omega-3 or Omega-3 combined with 81mg Aspirin) according to their assigned group.
Provide blood samples to measure changes in biochemical markers (IL-6, CRP).
详细描述
- Rationale Periodontitis is a chronic inflammatory disease caused by the host's immune response to pathogenic microorganisms, leading to clinical attachment loss and alveolar bone destruction. While non-surgical periodontal therapy (Scaling and Root Planing - SRP) is the gold standard, some patients experience disease progression due to residual subgingival biofilms.
This study explores Host Modulation Therapy (HMT) as an adjunct to SRP. The combination of Omega-3 fatty acids and low-dose Aspirin (81mg) is hypothesized to enhance the resolution of inflammation. Omega-3 serves as a substrate for pro-resolving mediators (Resolvins, Protectins, Maresins), while Aspirin triggers the synthesis of Aspirin-triggered Lipoxins via the COX-2 pathway. This synergistic approach aims to reduce systemic pro-inflammatory markers, specifically Interleukin-6 (IL-6) and C-reactive protein (CRP), and improve clinical healing. 2. Detailed Study Design This is a randomized controlled clinical trial involving 120 participants. Randomization: Participants who meet the inclusion criteria are randomly assigned to one of three groups (1:1:1 ratio). Randomization is performed using Excel software (RAND function) to generate a random sequence.
Allocation Concealment: Group assignments are placed in sealed, opaque envelopes and managed by a researcher not directly involved in the clinical treatment to ensure unbiased allocation. 3. Selection and Exclusion Criteria
Inclusion Criteria:
Age ≥ 20 years. Diagnosed with Stage III Periodontitis (Grade B or C) according to the 2017 AAP/EFP classification.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years. Diagnosed with Stage III Periodontitis (Grade B or C) according to the 2017 AAP/EFP classification.
- •Minimum of 16 natural teeth (excluding third molars and teeth indicated for extraction); at least 6 sites with Probing Pocket Depth (PPD) and Clinical Attachment Loss (CAL) ≥5mm, with bleeding on probing.
- •No periodontal treatment in the last 3 months; non-smokers
排除标准
- •Systemic conditions: Mental illness, HIV, autoimmune diseases, chronic hematological, renal, or respiratory diseases, Type 2 diabetes, or obesity.
- •Pregnancy or breastfeeding. Current use of ≥1g Omega-3/day or anticoagulants (Warfarin, Clopidogrel). History of gastrointestinal bleeding or peptic ulcers; allergy/hypersensitivity to Aspirin or Omega-3.
研究组 & 干预措施
SRP only
Full-mouth ultrasonic scaling and deep root planing using Gracey curettes. Subgingival irrigation with 0.12% Chlorhexidine. Polishing and oral hygiene instructions (modified Bass technique and interdental cleaning).
干预措施: Scaling and Root Planing (SRP) (Procedure)
SRP + Omega-3
SRP + Omega-3 (Now Foods, 300mg per capsule). Dosage: 4 capsules/day (2 in the morning, 2 in the evening after meals).
干预措施: Scaling and Root Planing (SRP) (Procedure)
SRP + Omega-3
SRP + Omega-3 (Now Foods, 300mg per capsule). Dosage: 4 capsules/day (2 in the morning, 2 in the evening after meals).
干预措施: Omega-3 Fatty Acids (Dietary Supplement)
SRP + Omega-3 + Aspirin
SRP + Omega-3 (4 capsules/day) + Aspirin 81mg (Agimexpharm). Dosage: 1 Aspirin tablet/day after breakfast.
干预措施: Scaling and Root Planing (SRP) (Procedure)
SRP + Omega-3 + Aspirin
SRP + Omega-3 (4 capsules/day) + Aspirin 81mg (Agimexpharm). Dosage: 1 Aspirin tablet/day after breakfast.
干预措施: Omega-3 Fatty Acids (Dietary Supplement)
SRP + Omega-3 + Aspirin
SRP + Omega-3 (4 capsules/day) + Aspirin 81mg (Agimexpharm). Dosage: 1 Aspirin tablet/day after breakfast.
干预措施: Low-dose aspirin (Drug)
结局指标
主要结局
Gingival Index (GI)
时间窗: Baseline, 3 months, 6 months, 12 months, and 24 months
Assessment of the severity and quality of gingival inflammation based on visual inspection and bleeding upon sweeping the probe.
Probing Pocket Depth (PPD)
时间窗: Baseline, 3 months, 6 months, 12 months, and 24 months
Measured as the distance from the gingival margin to the bottom of the periodontal pocket using a William's periodontal probe. Values are reported in millimeters (mm). Higher values indicate deeper pockets and greater periodontal disease severity.
Serum Interleukin-6 (IL-6) Concentration
时间窗: Baseline, 3 months, 6 months, 12 months, and 24 months
Quantification of serum IL-6 levels using the electrochemiluminescence immunoassay (ECLIA) to evaluate systemic anti-inflammatory effects. Values are reported in picograms per milliliter (pg/mL). Higher values indicate higher levels of systemic inflammation.
Serum C-Reactive Protein (CRP) Concentration
时间窗: Baseline, 3 months, 6 months, 12 months, and 24 months
Quantitative assessment of high-sensitivity CRP in serum to monitor the systemic inflammatory response. Values are reported in milligrams per liter (mg/L). Higher values indicate a more significant systemic inflammatory response.
Modified Gingival Index (MGI)
时间窗: Baseline, 3 months, 6 months, 12 months, and 24 months
Assessment of the severity of gingival inflammation using the Modified Gingival Index (MGI) by Lobene. This is a non-invasive index based on visual inspection of the gingiva. The scale for each site ranges from 0 to 4 (0 = Absence of inflammation; 1 = Mild inflammation in any portion of the gingival unit; 2 = Mild inflammation in the entire gingival unit; 3 = Moderate inflammation; 4 = Severe inflammation). The outcome is reported as the mean score of all sites. Total scores range from 0 to 4, where higher scores indicate greater severity of gingival inflammation.
次要结局
- Full-mouth Bleeding on Probing (BOP) Percentage(Baseline, 3 months, 6 months, 12 months, and 24 months)
- Clinical Attachment Loss (CAL)(Baseline, 3 months, 6 months, 12 months, and 24 months)
- Full-mouth Plaque Score (FMPS)(Baseline, 3 months, 6 months, 12 months, and 24 months)
- Lactate Dehydrogenase (LDH) Levels(Baseline, 3 months, 6 months, 12 months, and 24 months)
研究者
Nguyen Ngoc Hoa
Lecturer
Hanoi Medical University