Antibacterial Effectiveness of Frankincense-Based Herbal Irrigant Against Endodontic Microflora Using Real-Time PCR - A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in Total Bacterial Load
研究概览
简要总结
This research study is being done to find out if a natural ingredient called frankincense can clean infected root canals as effectively as the standard cleaning solution currently used in dentistry.
When a tooth's nerve dies from infection, dentists use a strong cleaning liquid, called sodium hypochlorite, to kill bacteria inside the tooth before filling it. This liquid works well, but it can sometimes irritate the gums or taste unpleasant. Frankincense, a natural substance long used in Oman, has shown early signs in laboratory studies that it may also fight bacteria effectively, with fewer side effects.
In this study, patients needing root canal treatment for an infected, dead tooth will be randomly placed into one of two groups. One group will have their tooth cleaned with the standard liquid. The other group will have their tooth cleaned with the frankincense-based liquid. Before and after cleaning, a small, painless sample will be taken from inside the tooth to measure how much bacteria is present, using a lab test called PCR. The results from both groups will then be compared to see which cleaning liquid removes more bacteria.
Patients who are between 18 and 50 years old, and who need root canal treatment for a dead/infected tooth, may be able to join. The study involves no extra visits beyond normal root canal treatment.
详细描述
This is a single-center, randomized, active-controlled clinical trial evaluating a standardized frankincense-based intracanal irrigant compared with 3% sodium hypochlorite (NaOCl) in patients with pulpal necrosis, conducted at Oman Dental College.
Eligible participants are adults aged 18-50 years diagnosed with pulpal necrosis (single- or multi-rooted teeth), with or without apical periodontitis. Exclusion criteria include periodontal pockets greater than 4 mm, calcified canals, acute apical abscess, internal resorption, open apex, retreatment cases, antibiotic therapy within the prior 3 months, pregnancy, and systemic comorbidities.
Thirty root canals will be enrolled and allocated 1:1 to two groups using block randomization: Group A (control) will receive standard 3% NaOCl, and Group B (intervention) will receive a standardized frankincense-based irrigant. Both irrigants will be delivered using the same standardized volume (approximately 5 mL) and activation time (30-60 seconds) to ensure the only planned difference between groups is the irrigant itself.
A pre-irrigation microbial sample will be collected from each canal using a sterile paper point, followed by irrigation with the assigned solution, and then a post-irrigation sample. Samples will be analyzed by quantitative real-time PCR (qPCR) for total bacterial load (universal 16S rRNA) and for Enterococcus faecalis specifically. Laboratory personnel performing the qPCR analysis, and the statistician analyzing the data, will be blinded to group allocation using coded sample identifiers.
The primary outcome is the log10 reduction in total bacterial load from pre- to post-irrigation. Secondary outcomes include the percentage reduction in bacterial load between groups, the reduction in E. faecalis counts, and adverse events (e.g., tissue irritation, discomfort). Statistical analysis will use paired t-tests or Wilcoxon signed-rank tests for within-group comparisons, and independent t-tests or Mann-Whitney U tests for between-group comparisons, with significance set at p<0.05
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Laboratory personnel performing qPCR analysis and the data analyst are blinded to group allocation via coded study/sample identifiers. The allocation key is held by an independent study coordinator/statistician not involved in clinical procedures and released only after data lock. Clinicians and participants cannot be blinded due to visible/olfactory differences between irrigants."
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-50 years
- •Diagnosis of pulpal necrosis (single- or multi-rooted tooth), with or without apical periodontitis
- •Tooth suitable for standard endodontic access and microbiological sampling
排除标准
- •Periodontal pockets >4 mm
- •Calcified canals
- •Acute apical abscess
- •Internal resorption
- •Open apex
- •Retreatment cases
- •Antibiotic/ herbal therapy within the prior 3 months
- •Pregnancy
- •Systemic comorbidities
研究组 & 干预措施
3% Sodium Hypochlorite (Control)
Participants randomized to this arm will receive standard 3% sodium hypochlorite (NaOCl) irrigation, the clinic's current standard-of-care irrigant, prepared according to institutional protocol. Approximately 5 mL of irrigant will be delivered per canal, with 30-60 seconds of activation (manual dynamic or sonic agitation), following standardized access, minimal instrumentation, and pre-irrigation microbiological sampling. A post-irrigation sample will be taken via sterile paper point immediately after irrigation.
干预措施: Sodium hypochlorite 3% (Drug)
Frankincense-Based Herbal Irrigant (Intervention)
Participants randomized to this arm will receive a standardized frankincense-based irrigant (Boswellia sacra-derived extract), formulated at a fixed concentration and pH, with batch sterility and endotoxin testing and stability/compatibility testing completed prior to clinical use. Approximately 5 mL of irrigant will be delivered per canal, with 30-60 seconds of activation (manual dynamic or sonic agitation, final protocol to be fixed prior to trial start), using the same standardized volume, activation method, and contact time as the control arm, following standardized access, minimal instrumentation, and pre-irrigation microbiological sampling. A post-irrigation sample will be taken via sterile paper point immediately after irrigation.
干预措施: Frankincense-based irrigant (Drug)
结局指标
主要结局
Reduction in Total Bacterial Load
时间窗: 1 hour. First sample will be taken pre-intervention/procedural (before chemo-mechanical preparation) and the second sample will be taken immediately after the intervention (after completion of chemo-mechanical preparation) in the same clinical visit.
The change in total endodontic bacterial load, measured by quantitative real-time PCR (qPCR) targeting the universal 16S rRNA gene, calculated as log10(pre-irrigation bacterial load) minus log10(post-irrigation bacterial load). Assessed and compared between the frankincense-based irrigant group and the 3% NaOCl group.
Percentage Reduction in Total Bacterial Load Between Groups
时间窗: This can be also referred to as Pre-procedural and post-procedural; the procedure being pulp extirpation followed by irrigation, cleaning and shaping of the rootcanals, within a single clinical visit; 1 hour. Pre-intervention & post-intervention samples
Comparison of the percentage reduction in total bacterial load (16S rRNA qPCR) between the frankincense-based irrigant group and the 3% NaOCl group. Time Frame: Within a single clinical visit; pre- to post-irrigation
次要结局
未报告次要终点