Caffeine Intake and Periodontal Treatment Outcomes
14 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
90
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Haoran Feng, BS
- Numéro de téléphone: +86 13815309288
- E-mail: fenghaoran0611@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Lei Wang, BS
- Numéro de téléphone: +86 19961910284
- E-mail: 657952067@qq.com
Lieux d'étude
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Jiangsu
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Xuzhou, Jiangsu, Chine, 221000
- Affiliated Stomatological Hospital of Xuzhou Medical University
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Contact:
- Haoran Feng, BS
- Numéro de téléphone: +86 13815309288
- E-mail: fenghaoran0611@gmail.com
-
Contact:
- Lei Wang, BS
- Numéro de téléphone: +86 19961910284
- E-mail: 657952067@qq.com
-
Chercheur principal:
- Haoran Feng, BS
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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Expérimental: 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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Expérimental: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean Change From Baseline in Salivary Matrix Metalloproteinase-8 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
Délai: 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.
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Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
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Mean Change From Baseline in Salivary Interleukin-1 Beta Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Change From Baseline in Salivary Interleukin-6 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
Délai: 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
Délai: 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.
|
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Mean Change From Baseline in the Relative Abundance of Porphyromonas gingivalis in Saliva at 2 Weeks, 1 Month, 3 Months, and 6 Months.
Délai: 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.
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Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.
|
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Mean Change From Baseline in Full-Mouth Mean Probing Depth at 2 Weeks, 1 Month, 3 Months, and 6 Months
Délai: 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.
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Mean Change From Baseline in Full-Mouth Mean Clinical Attachment Level at 2 Weeks, 1 Month, 3 Months, and 6 Months
Délai: 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
|
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Mean Change From Baseline in the Percentage of Periodontal Sites With Bleeding on Probing at 2 Weeks, 1 Month, 3 Months, and 6 Months
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Haoran Feng, Affiliated Stomatological Hospital of Xuzhou Medical University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
31 décembre 2027
Achèvement de l'étude (Estimé)
31 décembre 2027
Dates d'inscription aux études
Première soumission
26 juillet 2026
Première soumission répondant aux critères de contrôle qualité
30 juillet 2026
Première publication (Réel)
5 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-KY-008-02
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
Beginning 6 months after publication and ending 5 years after publication.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .