Caffeine Intake and Periodontal Treatment Outcomes
2026년 8월 14일 업데이트: Haoran Feng
Effects of Dietary Caffeine Intake on Periodontal Treatment Outcomes: A Randomized Controlled 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
90
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Haoran Feng, BS
- 전화번호: +86 13815309288
- 이메일: fenghaoran0611@gmail.com
연구 연락처 백업
- 이름: Lei Wang, BS
- 전화번호: +86 19961910284
- 이메일: 657952067@qq.com
연구 장소
-
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Jiangsu
-
Xuzhou, Jiangsu, 중국, 221000
- Affiliated Stomatological Hospital of Xuzhou Medical University
-
연락하다:
- Haoran Feng, BS
- 전화번호: +86 13815309288
- 이메일: fenghaoran0611@gmail.com
-
연락하다:
- Lei Wang, BS
- 전화번호: +86 19961910284
- 이메일: 657952067@qq.com
-
수석 연구원:
- Haoran Feng, BS
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
3
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
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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.
|
|
실험적: 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.
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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.
|
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실험적: 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.
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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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Change From Baseline in Salivary Matrix Metalloproteinase-8 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
기간: 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.
|
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
기간: 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.
|
Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Change From Baseline in Salivary Interleukin-6 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
기간: 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.
|
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
기간: 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.
|
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.
기간: 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.
|
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
기간: 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.
|
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
기간: 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.
|
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
기간: 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.
|
Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Haoran Feng, Affiliated Stomatological Hospital of Xuzhou Medical University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 8월 1일
기본 완료 (추정된)
기본 완료
2027년 12월 31일
연구 완료 (추정된)
연구 완료
2027년 12월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 26일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 30일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 18일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 14일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- 2026-KY-008-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
De-identified individual participant data used for the published results will be shared, including demographic information, periodontal clinical parameters, salivary inflammatory biomarker measurements (MMP-8, IL-1β, and IL-6), and oral microbiome sequencing data.
The study protocol and statistical analysis plan will also be available upon reasonable request.
IPD 공유 기간
Beginning 6 months after publication and ending 5 years after publication.
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .