Caffeine Intake and Periodontal Treatment Outcomes

NCT07747545 | Not Yet Recruiting

• 1 other identifier: 2026-KY-008-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

Dietary caffeine; Non-surgical periodontal therapy; Oral microbiome; Salivary inflammatory biomarkers; Randomized controlled trial; Periodontitis

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention

• 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.

  Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention

Secondary Outcomes (6)

• 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

Study Arms (3)

No Caffeine Intake Group

EXPERIMENTAL

Participants will receive standard non-surgical periodontal treatment and will be instructed to avoid dietary caffeine intake throughout the 6-month study period.

Dietary Supplement: No Caffeine Intake

Low Caffeine Intake Group

EXPERIMENTAL

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 Supplement: Low Caffeine Intake

Moderate Caffeine Intake Group

EXPERIMENTAL

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.

Dietary Supplement: Moderate Caffeine Intake

Interventions

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.

No Caffeine Intake Group

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.

Low Caffeine Intake Group

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.

Moderate Caffeine Intake Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haoran Feng: lead
• Affiliated Stomatological Hospital of Xuzhou Medical University: collaborator

Study Sites (1)

Affiliated Stomatological Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Haoran Feng

  Affiliated Stomatological Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haoran Feng, BS

CONTACT

+86 13815309288; fenghaoran0611@gmail.com

Lei Wang, BS

CONTACT

+86 19961910284; 657952067@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Registered Nurse

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 5, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication and ending 5 years after publication.
• Access Criteria: De-identified individual participant data and supporting documents will be available to qualified researchers who submit a methodologically sound research proposal. Requests should be directed to the corresponding investigator. Access will be granted after review and approval of the proposal and execution of a data sharing agreement, in accordance with institutional policies and applicable ethical requirements.

Locations

CN (1)