Caffeine Intake and Periodontal Treatment Outcomes
ConditionPeriodontitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHaoran Feng
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
No Caffeine Intake
Dietary supplementParticipants will receive standard non-surgical periodontal treatment and will be instructed to avoid all dietary sources of caffeine throughout the 6-month study period.
Low Caffeine Intake
Dietary supplementParticipants will receive standard non-surgical periodontal treatment and will consume approximately 50 mg of dietary caffeine per day throughout the 6-month study period.
Moderate Caffeine Intake
Dietary supplementParticipants will receive standard non-surgical periodontal treatment and will consume approximately 100 mg of dietary caffeine per day throughout the 6-month study period.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: No Caffeine Intake GroupExperimental treatment 1 intervention
Group B: Low Caffeine Intake GroupExperimental treatment 1 intervention
Group C: Moderate Caffeine Intake GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Change From Baseline in Salivary Matrix Metalloproteinase-8 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
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.
Time frame
Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention2
Mean Change From Baseline in Salivary Interleukin-1 Beta Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
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.
Time frame
Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the interventionSecondary outcomes
1
Mean Change From Baseline in Salivary Interleukin-6 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
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.
Time frame
Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention2
Mean Change From Baseline in the Shannon Diversity Index of the Salivary Microbiome at 2 Weeks, 1 Month, 3 Months, and 6 Months
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.
Time frame
Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.3
Mean Change From Baseline in the Relative Abundance of Porphyromonas gingivalis in Saliva at 2 Weeks, 1 Month, 3 Months, and 6 Months.
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.
Time frame
Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.4
Mean Change From Baseline in Full-Mouth Mean Probing Depth at 2 Weeks, 1 Month, 3 Months, and 6 Months
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.
Time frame
Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Haoran Feng
Lead sponsor
Affiliated Stomatological Hospital of Xuzhou Medical University
Sponsor institution
Affiliated Stomatological Hospital of Xuzhou Medical University
Collaborator
Source ClinicalTrials.gov
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