Effects of Dietary Caffeine Intake on Periodontal Treatment Outcomes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Salivary Matrix Metalloproteinase-8 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
研究概览
简要总结
This study will explore whether caffeine intake can affect recovery after periodontal (gum) treatment.
Periodontitis is a common gum disease caused by bacteria. Even after treatment, some people may still have ongoing inflammation or changes in oral bacteria. Researchers want to know if daily caffeine intake, such as from coffee, may help improve this condition.
In this study, about 90 adults with periodontitis will receive standard periodontal treatment. Participants will be randomly assigned to one of three groups: no caffeine intake, low caffeine intake, or moderate caffeine intake. They will follow these instructions for about 6 months.
Researchers will collect saliva samples and check gum health at several time points after treatment. Saliva will be used to measure inflammation markers and to study changes in oral bacteria. Researchers will also record clinical gum conditions, such as gum pocket depth and bleeding.
The goal of this study is to understand whether caffeine intake can help reduce inflammation, improve oral bacteria balance, and support recovery after periodontal treatment. The results may help provide simple dietary advice to improve long-term gum health.
详细描述
This study is a randomized controlled trial designed to evaluate the effects of dietary caffeine intake on periodontal treatment outcomes and potential biological mechanisms.
Periodontitis is a chronic inflammatory disease associated with microbial imbalance and increased inflammatory activity. Although standard periodontal treatment can control disease progression, some individuals may continue to experience persistent inflammation during the maintenance phase.
Approximately 90 adults with periodontitis will be recruited and will receive standard non-surgical periodontal treatment. Participants will be randomly assigned to one of three groups according to caffeine intake: no intake, low intake, and moderate intake.
Participants will be followed for 6 months. Saliva samples will be collected at baseline and multiple follow-up time points. These samples will be used to assess inflammatory biomarkers and oral microbiome characteristics. Clinical periodontal parameters will also be recorded during follow-up.
This study aims to evaluate whether dietary caffeine intake influences inflammatory responses, oral microbiome characteristics, and clinical periodontal outcomes after periodontal treatment. The findings may provide evidence for incorporating dietary factors into periodontal disease management.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 55 years.
- •Diagnosed with periodontitis according to the 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions.
- •First visit for periodontal treatment and eligible for standard non-surgical periodontal therapy.
- •Willing and able to comply with the dietary intervention and scheduled follow-up visits.
- •Able to understand the study procedures and provide written informed consent.
- •Able to communicate effectively and complete study questionnaires and follow-up assessments.
排除标准
- •Pregnant or breastfeeding women, or women planning pregnancy during the study period.
- •History of periodontal treatment within the previous 6 months.
- •Current smokers or tobacco users.
- •Use of antibiotics, anti-inflammatory drugs, immunosuppressive agents, or medications known to affect periodontal status within the previous 3 months.
- •Presence of systemic diseases that may influence periodontal conditions, including diabetes mellitus, hypertension, or hyperlipidemia.
- •Severe systemic diseases, psychiatric disorders, or other conditions that may interfere with study participation or protocol compliance.
- •Allergy or intolerance to caffeine or inability to comply with the dietary caffeine intervention.
- •Individuals with limited hand function or other conditions preventing adequate oral hygiene practices.
研究组 & 干预措施
Low Caffeine Intake Group
Participants will receive standard non-surgical periodontal treatment and will consume approximately 50 mg of dietary caffeine per day throughout the 6-month study period.
干预措施: Low Caffeine Intake (Dietary Supplement)
No Caffeine Intake Group
Participants will receive standard non-surgical periodontal treatment and will be instructed to avoid dietary caffeine intake throughout the 6-month study period.
干预措施: No Caffeine Intake (Dietary Supplement)
Moderate Caffeine Intake Group
Participants will receive standard non-surgical periodontal treatment and will consume approximately 100 mg of dietary caffeine per day throughout the 6-month study period.
干预措施: Moderate Caffeine Intake (Dietary Supplement)
结局指标
主要结局
Mean Change From Baseline in Salivary Matrix Metalloproteinase-8 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
时间窗: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
Unstimulated whole saliva will be collected at baseline and at 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention. Salivary matrix metalloproteinase-8 concentration will be quantified using a commercial enzyme-linked immunosorbent assay kit. For each participant, change from baseline will be calculated separately at each post-baseline time point. The outcome will be summarized as the mean change from baseline for each intervention arm at each time point.
Mean Change From Baseline in Salivary Interleukin-1 Beta Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
时间窗: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
Unstimulated whole saliva will be collected at baseline and at 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention. Salivary interleukin-1 beta concentration will be quantified using a commercial enzyme-linked immunosorbent assay kit. For each participant, change from baseline will be calculated separately at each post-baseline time point. The outcome will be summarized as the mean change from baseline for each intervention arm at each time point.
次要结局
- Mean Change From Baseline in Salivary Interleukin-6 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months(Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention)
- Mean Change From Baseline in the Shannon Diversity Index of the Salivary Microbiome at 2 Weeks, 1 Month, 3 Months, and 6 Months(Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.)
- Mean Change From Baseline in the Relative Abundance of Porphyromonas gingivalis in Saliva at 2 Weeks, 1 Month, 3 Months, and 6 Months.(Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.)
- Mean Change From Baseline in Full-Mouth Mean Probing Depth at 2 Weeks, 1 Month, 3 Months, and 6 Months(Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.)
- Mean Change From Baseline in Full-Mouth Mean Clinical Attachment Level at 2 Weeks, 1 Month, 3 Months, and 6 Months(Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention)
- Mean Change From Baseline in the Percentage of Periodontal Sites With Bleeding on Probing at 2 Weeks, 1 Month, 3 Months, and 6 Months(Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention)
研究者
Haoran Feng
Senior Registered Nurse
Affiliated Stomatological Hospital of Xuzhou Medical University