Periodontitis
Conditions
Keywords
Dietary caffeine, Caffeine intake, Non-surgical periodontal therapy, Oral microbiome, Salivary inflammatory biomarkers, Randomized controlled trial, Periodontitis
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTNo Caffeine Intake
Participants will receive standard non-surgical periodontal treatment and will be instructed to avoid all dietary sources of caffeine throughout the 6-month study period.
DIETARY_SUPPLEMENTLow Caffeine Intake
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.
DIETARY_SUPPLEMENTModerate Caffeine Intake
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.
Sponsors
Haoran Feng
Affiliated Stomatological Hospital of Xuzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: no caffeine intake, low caffeine intake (approximately 50 mg/day), or moderate caffeine intake (approximately 100 mg/day). Each participant will remain in the assigned group throughout the 6-month follow-up period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Salivary Matrix Metalloproteinase-8 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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-6 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 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. | Salivary microbiome composition will be assessed using 16S ribosomal RNA gene sequencing. Alpha diversity will be quantified using the Shannon diversity index at baseline and at 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention. 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 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. | The relative abundance of Porphyromonas gingivalis in saliva will be estimated using 16S ribosomal RNA gene sequencing and reported as a percentage. For each participant, change from baseline will be calculated separately at 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention. The outcome will be summarized as the mean change in percentage points for each intervention arm at each time point. |
| 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. | Probing depth will be measured in millimeters by one trained and calibrated periodontal examiner using a Florida electronic periodontal probe at six sites per tooth. For each participant, full-mouth mean probing depth will be calculated across all examined periodontal sites at each assessment. Change from baseline will be calculated separately at 2 weeks, 1 month, 3 months, and 6 months. The outcome will be summarized as the mean change from baseline for each intervention arm at each time point. |
| 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 | Clinical attachment level will be measured in millimeters by one trained and calibrated periodontal examiner using a Florida electronic periodontal probe at six sites per tooth. For each participant, full-mouth mean clinical attachment level will be calculated across all examined periodontal sites at each assessment. Change from baseline will be calculated separately at 2 weeks, 1 month, 3 months, and 6 months. The outcome will be summarized as the mean change from baseline for each intervention arm at each time point. |
| 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 | Bleeding on probing will be assessed by one trained and calibrated periodontal examiner at six sites per tooth. For each participant, the percentage of periodontal sites with bleeding on probing will be calculated as the number of sites showing bleeding divided by the total number of sites examined, multiplied by 100. Change from baseline will be calculated separately at 2 weeks, 1 month, 3 months, and 6 months. The outcome will be summarized as the mean change in percentage points for each intervention arm at each time point. |
Countries
China
Contacts
CONTACTHaoran Feng, BS
CONTACTLei Wang, BS
PRINCIPAL_INVESTIGATORHaoran Feng
Affiliated Stomatological Hospital of Xuzhou Medical University
Outcome results
None listed