NCT07755800Enrolling By Invitation不适用
Impact of an Arginine-containing Toothpaste on the Subgingival Microbiota in Patients in Supportive Periodontal Care
Sukirth M Ganesan, BDS, PhD1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2026年8月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Changes in the abundance of microbial strains will be evaluated in all enrolled participants by collecting subgingival dental plaque, followed by genomic profiling of the samples.
研究概览
简要总结
This study aims to see how a toothpaste with arginine affects bacteria below the gum line compared to a regular fluoride toothpaste. It focuses on people with gum disease who are already getting ongoing dental care.
The main questions it aims to answer are:
- How does an arginine toothpaste affect the bacteria below the gumline?
- How does a fluoride toothpaste affect the bacteria below the gumline?
Participants will:
- Use fluoride toothpaste or arginine toothpaste twice daily for 6 months
- After receiving the toothpaste at the baseline visit, subjects will visit the clinic at 3 months and 6 months for additional data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understands and is willing to sign an Informed Consent, approved by the local Ethics Committee.
- •Female or male, ages 18-95 years old (inclusive)
- •Systemically healthy.
- •Presence of at least three evaluable teeth in each quadrant.
- •Moderate gingival inflammation, with at least a 10% of bleeding on probing (BOP) will be required together with moderate level of plaque.
- •No Grade 3 Tooth Mobility
- •Treated stage II or III periodontitis patients, whose active treatment has finalized more than 6 months before. Stage II - Interdental clinical attachment level (CAL) at the site of greatest loss equal to 3 to 4 millimeters with maximum probing depth of less than or equal to 5 millimeters. Stage III - Interdental CAL at the site of greatest loss greater than equal to 5 millimeters, probing depth (PD) greater than or equal to 6 millimeters, and radiographic vertical bone loss
- •Enrolled in a periodontal maintenance treatment program
- •No orthodontic banding (no permanent retainers, no orthodontic appliances (i.e., no removable plastic/metal retainer) or removable prosthesis (no removable partial and/or full denture).
- •Subjects willing to participate and comply with the requirements of the study.
- •Subjects that brush their teeth regularly (once or twice daily).
- •Able to travel to and attend 4 research study visits over the span of the next 6 months.
- •Able to independently provide consent for oneself.
- •Fluent in reading, comprehending, and speaking English without assistance from a translator.
- •If a patient is using prevident, they must be willing to stop using it.
排除标准
- •Untreated or uncontrolled periodontitis or advanced (advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss)
- •Antibiotics intake within the previous month.
- •Pregnant women and/or breastfeeding women
- •Any adverse medical history (controlled and uncontrolled diabetes, osteoporosis, immunosuppression…) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions.
- •Conditions which require antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).
- •Not willing to comply with the study protocol recommendation and visit schedule.
- •Current smokers or those using tobacco or vaping products.
- •Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care
- •Currently participating in another clinical research study now and/or within the past month.
- •Has a history of allergies to oral care or personal care consumer products or their ingredients
- •Has an existing medical condition that prohibits eating or drinking for periods up to 4 hours.
- •Any ongoing medical condition that makes a subject unsuitable for enrollment-or any new diagnosis that arises during the study that makes the subject unsuitable to continue-may lead to exclusion, as determined by the Principal Investigator on a case by case basis. Conditions that may result in exclusion include, but are not limited to:
- •Recent myocardial infarction
- •Recent cerebrovascular accident
- •Recent placement of a cardiac valvular prosthesis
- •Severe liver dysfunction
- •Known or suspected current malignancy
- •New antibiotic use
- •Note: The Principal Investigator will review all available information about the subject and make decisions regarding both enrollment and/or continued participation.
研究组 & 干预措施
Arginine Toothpaste Use for Two Times Per Day for 6 Months
Experimental
干预措施: Arginine Toothpaste (Device)
Fluoride Toothpaste Use for Two Times Per Day for 6 Months
Active Comparator
干预措施: Fluoride Toothpaste (Device)
结局指标
主要结局
Changes in the abundance of microbial strains will be evaluated in all enrolled participants by collecting subgingival dental plaque, followed by genomic profiling of the samples.
时间窗: Baseline, 3 months, and 6 months
次要结局
未报告次要终点
研究者
Sukirth M Ganesan, BDS, PhD
Principal Investigator
University of Iowa
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Evaluation of the Effect of the Toothpaste on Delicate GumsGingivitisNCT07494747Lacer S.A.60
已完成
不适用
Touch-to-Teach Interdental Brush Instruction Versus Conventional Guidance on Gingival Health in Patients With Fixed Dental ProsthesesGingivitisPeriodontal DiseaseFixed Dental ProsthesisDental PlaqueNCT07636954Gulf Medical University32
尚未招募
3 期
After professional cleaning for gum disease, does probiotic (good bacteria) toothpaste or regular fluoride toothpaste work better in reducing harmful bacteria.Chronic periodontitis,CTRI/2026/04/108533Dr Anoop S102
尚未招募
不适用
Is Black Raisin Toothpaste as Effective as Fluoride Toothpaste in Preventing Cavities in Children?NORMALCTRI/2025/03/082637Dr VVN Karthik392
已完成
不适用
Evaluation of Toothpaste Effect in Volunteers With Dental SensitivityDental SensitivityNCT07593755Lacer S.A.71