A Clinical Study to Evaluate the Efficacy of an Experimental Oralbalance Gel, Oral Rinse and Spray Versus Water
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 422
- 主要终点
- Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)
研究概览
简要总结
This study assessed the efficacy of three dry mouth products (including an experimental Oralbalance gel, oral rinse, and moisturizing spray) to relieve the feeling of dry mouth compared to water, in dry mouth population over a period of 28 days.
详细描述
This was a multi-centered (two-sites), examiner-blinded, four treatment arms, stratified (by Modified Dry Mouth Inventory [DMI] score), randomized, parallel group study in participants with self-reported dry mouth symptoms as determined by participant responses to the DMI. Participants used their assigned dry mouth treatment at home for 28 days.
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
- Single (Outcomes Assessor)
盲法说明
The examiner and site staff reviewing the efficacy assessments were blinded to the treatment allocation of participants. All other study personnel (study statistician, data management staff and other employees of the Sponsor who may influence study outcomes) were blinded to the study treatments.
入排标准
- 年龄范围
- 35 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- •Understands and is willing, able and likely to comply with all study procedures and restrictions.
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination., b) Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements. Subjects with stable and controlled medical conditions with no overt medical conditions which would contraindicate participation (in the opinion of the Investigator or medically qualified designee) which would interfere with the conduct of the study.
- •Self reported feeling of a dry mouth according to the modified DMI questions. Subject must answer at least 3 out of 5 questions with 'agree a little', 'agree' or 'strongly agree'.
排除标准
- •Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- •Women who are breast-feeding.
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- •Previous participation in this study.
- •Recent history (within the last 1 year) of alcohol or other substance abuse.
- •An employee of the sponsor or the study site or members of their immediate family.
- •Subject works in one of the following: Advertising, Journalism, Public Relations, Manufacturing, retail or distribution of medicines, medical devices or healthcare products, Market Research or Marketing.
- •Use of prescription systemic parasympathetic medications (e.g. Pilocarpine), for the treatment of the feeling of dry mouth.
- •At the discretion of the examiner, subjects currently under the care of a dental/medical professional specifically for the treatment of dry mouth.
- •Evidence of gross intra-oral neglect or need for extensive dental therapy.
- •Denture wearer (partial or complete dentures).
- •Subject with dental implants.
- •Subjects with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration).
- •Subject is currently undergoing radiotherapy and/or chemotherapy treatment.
- •Any condition the investigator identifies that can confound the subject's ability to properly participate in the study e.g. Alzheimer's Disease.
研究组 & 干预措施
OralBalance moisturizing gel
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
干预措施: Experimental Oralbalance Moisturizing Gel (Device)
Oral rinse
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
干预措施: Biotene Original Oral Rinse (Device)
Moisturizing mouth spray
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
干预措施: Biotene Moisturizing Mouth Spray (Device)
Water only use
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
干预措施: Water (Other)
结局指标
主要结局
Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)
时间窗: At Day 29 of treatment (2 hours after supervised product use)
Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 2 hours after supervised product use on Day 29 of treatment.
次要结局
- Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29(At Day 29 of treatment (30 minutes, 1 hour and 4 hours after supervised product use))
- Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1(At Day 1 of treatment (30 minutes, 1 hour, 2 and 4 hours after supervised product use))
- Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)(At Day 1 and 29 (30 minutes, 1 hour, 2 and 4 hours after supervised product use))
- Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8(At Day 8 (2 hours after supervised product use))
- Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)(At Day 8 and 29)
- Area Under Curve (AUC) up to 4 Hours After Treatment- Response of All Question of the Modified Product Performance and Attributes Questionnaire I (PPAQ I)(At Day 1 and 29)