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NCT Number: NCT07747545

Caffeine Intake and Periodontal Treatment Outcomes

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Caffeine Intake

Dietary Supplement

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.

Low Caffeine Intake

Dietary Supplement

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.

Moderate Caffeine Intake

Dietary Supplement

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.

Primary outcomes

  1. Mean Change From Baseline in Salivary Matrix Metalloproteinase-8 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months

    Time frame: 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.

  2. Mean Change From Baseline in Salivary Interleukin-1 Beta Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months

    Time frame: 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 outcomes

  1. Mean Change From Baseline in Salivary Interleukin-6 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months

    Time frame: 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.

  2. Mean Change From Baseline in the Shannon Diversity Index of the Salivary Microbiome at 2 Weeks, 1 Month, 3 Months, and 6 Months

    Time frame: 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.

  3. Mean Change From Baseline in the Relative Abundance of Porphyromonas gingivalis in Saliva at 2 Weeks, 1 Month, 3 Months, and 6 Months.

    Time frame: 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.

  4. Mean Change From Baseline in Full-Mouth Mean Probing Depth at 2 Weeks, 1 Month, 3 Months, and 6 Months

    Time frame: 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.

  5. Mean Change From Baseline in Full-Mouth Mean Clinical Attachment Level at 2 Weeks, 1 Month, 3 Months, and 6 Months

    Time frame: 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.

  6. Mean Change From Baseline in the Percentage of Periodontal Sites With Bleeding on Probing at 2 Weeks, 1 Month, 3 Months, and 6 Months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haoran Feng, BS

CONTACT

[email protected]

+86 13815309288

Lei Wang, BS

CONTACT

[email protected]

+86 19961910284

Sponsors and collaborators

Lead sponsor

Haoran Feng

Other

Collaborators

  • Affiliated Stomatological Hospital of Xuzhou Medical University

Registry information

Official study title

Effects of Dietary Caffeine Intake on Periodontal Treatment Outcomes: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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