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临床试验/NCT05470023
NCT05470023招募中不适用

Imaging-based Assessment of Oral Biofilm and Gingival Health

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
275
试验地点
2
主要终点
Plaque level at Month 3

研究概览

简要总结

The purpose of this research study is to develop a better way of measuring the health of patients' mouth using photographs and imaging software. The investigators will also study the specific effects of individual toothpastes and mouthwashes on oral health.

Participants who have volunteered to be in the study will be asked to use a toothpaste or over a period of 7 days to 6 months. The investigators will determine the participants' oral plaque levels, gum health, and saliva (spit) production with clinical exams as well as photographs of the participants' mouths. It is the hope of the study team to find better ways of assessing the health of patients' mouths and to identify whether gum health can be improved by specific toothpastes or mouthwashes.

详细描述

Participants will be asked whether they fulfill study inclusion/exclusion criteria. If recruited, they will be asked to sign the informed consent form. No professional dental cleaning will be performed before or during the trial in order to avoid the influence this would have on the data gathered. Participants will be randomly assigned to use one of the oral care products, which are all OTC products and will be used in the intended manner.

For toothpastes, participants will be asked to brush twice daily for the study duration with one of the following test dental gels: LivFresh Dental Gel (Livionex, Los Gatos, CA); LivFree Dental Gel (Los Gatos, CA); AIM (Church and Dwight, Ewing, NJ); Parodontax (GSK, Philadelphia, PA); Crest Prohealth (P&G, Cincinnati, OH); and Colgate Total (Colgate-Palmolive, New York, NY). A standard Oral B ProFlexR toothbrush will be provided to each volunteer, and participants will be trained in standard sulcular brushing technique. Participants will brush participants' teeth two hours prior to each visit and refrain from eating from that time onwards until after participants' visit. Participants allocated to mouthrinse use will continue with participants' usual oral hygiene protocol; additionally, the participants will be asked to rinse twice daily with 1 capful for 1 minute with the Lumineux Mouthrinse (Lumineux, Beverley Hills, CA) directly after brushing participants' teeth. Plaque levels (P.I.), gingival inflammation, and sulcus bleeding (mSBI) will be recorded.

A standardized periodontal probe will be used to measure pockets. Saliva production will be measured by asking participants to expectorate into a graduated cylinder for 5 minutes. Saliva will not be stored or analyzed in any way.

Volunteers will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images, thus automatically rendering the images unidentifiable with regard to each subject's facial appearance. These photos will not show the subject's face but will focus on the subject's mouth. Participants will be asked whether participants fulfill study inclusion/exclusion criteria inclusion/exclusion criteria.

Study duration will be 7 days or 1, 3, or 6 months. Each visit will last approximately 30 minutes. Initially, study duration will be 7 days as the investigators develop the imaging- based techniques. Once the techniques are finalized, study duration will be incrementally increased to 1 month, then 3 months, then 6 months to validate and refine the imaging-based techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

White tape over receptacle.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years of age or older
  • In good general health

排除标准

  • History of allergy or intolerance of oral hygiene products such as toothpastes and mouthrinses

结局指标

主要结局

Plaque level at Month 3

时间窗: 3 months

Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).

Gingival health (gingival index) at Month 3

时间窗: 3 months

Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).

Gingival health (sulcus bleeding index) at Month 1

时间窗: 1 month

Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

Gingival health (sulcus bleeding index) at Month 6

时间窗: 6 months

Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

Plaque level at Week 1

时间窗: 1 week

Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).

Plaque level at Month 6

时间窗: 6 months

Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).

Gingival health (gingival index) at Month 1

时间窗: 1 month

Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).

Gingival health (gingival index) at Month 6

时间窗: 6 months

Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).

Plaque level at Month 1

时间窗: 1 month

Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).

Gingival health (gingival index) at Week 1

时间窗: 1 week

Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).

Gingival health (sulcus bleeding index) at Week 1

时间窗: 1 week

Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

Gingival health (sulcus bleeding index) at Month 3

时间窗: 3 months

Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Petra E. Wilder-Smith

Professor of Surgery and Director of Dentistry

University of California, Irvine

研究点 (2)

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