A Pilot Clinical Study to Determine the Effect Denture Gel Has on the Prevention of Gum Abrasions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Mucosal Assessment
研究概览
简要总结
This is a parallel design study. Up to 40 subjects with a full mandibular and full maxillary dentures will be enrolled into the study. Subjects will use their current denture care +/- a treatment gel for 4 weeks. Subjects will have an Oral Soft Tissue exam, a Mucosa Condition Assessment, and a Pre-Gum Abrasion Evaluation followed by a peanut challenge and then have a Post-Gum Abrasion Evaluation at designated timepoints.
详细描述
This is a single center, two-treatment, parallel design study. Up to 40 subjects will be enrolled with a full mandibular and full maxillary denture with a history of food related abrasions.
At each visit, an Oral Soft Tissue exam, a Mucosa Condition Assessment and a Gum Abrasion Evaluation will be performed. At Baseline, the subjects will be randomized to a treatment group. At Baseline, Week 2, and Week 4 subjects will be asked to eat 20 grams of peanuts 4 times for a total consumption of 80 g of peanuts (subjects will be permitted to take breaks if needed and drink small sips of water). Following the peanut challenge, a licensed dental professional will re-evaluate the number and size of abrasions. Subjects will receive a consumer questionnaire to complete as well prior to the Baseline, Week 2, and Week 4 assessments.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be included in the study, each subject must:
- •Be 18 years of age;
- •Read, sign, and receive a copy of the Informed Consent prior to initiation of study procedures;
- •Have a full maxillary and mandibular denture and wear on a daily basis;
- •Have a history of food particles getting under their full denture and causing gum irritation;
- •Are willing to abstain from eating at least four hours prior to the visits;
- •Are willing to eat 4 X 20 grams of peanuts three times (Baseline, Week 2 and Week 4) without denture adhesive;
- •Clean their dentures on a daily basis;
- •Agree not to change their regular denture cleaning routine;
- •Agree to abstain from using denture adhesive during the study;
- •Agree to not participate in any other oral/dental product studies during the study.
排除标准
- •Exhibit evidence of obvious oral pathology, as determined by the Study Dentist, as a result of a mandatory OST examination on the first day of the study;
- •Are allergic to any of the ingredients contained in the study product gel;
- •Are allergic to peanuts;
- •Wear dentures overnight;
- •Are insulin-dependent and/or have any health condition(s) which would prevent compliance with study procedures;
- •Are routinely using denture adhesive;
- •Present with any disease or conditions that could be expected to increase their susceptibility to gum abrasion (like diabetes or xerostomia); or
- •Present with any disease or conditions that could be expected to interfere with examination procedures or the subject's safe completion of the study
结局指标
主要结局
Mucosal Assessment
时间窗: Week 4
The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score. The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy.
Abrasion Assessment (Number)
时间窗: Week 4
The total number of abrasions pre-food challenge
Abrasion Assessment (Size)
时间窗: Week 4
The average size/area (in mm) of the total number of abrasions pre-food challenge
次要结局
未报告次要终点