A Method Development Clinical Study to Investigate the Efficacy of the Different Frequencies of Use of a Denture Cleanser
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change From Baseline in Anaerobic Bacteria Microbial Count on Day 7
研究概览
简要总结
This method development study will be a two treatment arm, randomized, cross over study in a population with edentulous upper arch restored with a maxillary complete denture. The lower may be a partial or full edentulous mandibular arch that may be restored with a stable complete, partial or implant supported denture.
详细描述
This is a single-center, 2 treatment periods, examiner-blind, randomized, 7 day crossover study in adult participants with a complete maxillary denture. This is a method development study to investigate the changes in the level of denture plaque, microbial counts, microbial composition and stain on the maxillary dentures after daily denture cleanser use versus dentures that are cleaned weekly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 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 procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- •Aged between 18 and 84 years inclusive.
- •Good general and mental health with, in the opinion of the Investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination; Absence of any condition that could affect the participant's safety or wellbeing or their ability to understand and follow study procedures and requirements.
- •Maxillary Arch: Completely edentulous maxillary arch restored with a conventional full acrylic based upper complete denture.
- •Mandibular Arch: Dentate, partial or full edentulous mandibular arch. Partial or full edentulous arch may be restored with a stable complete, partial or implant supported denture. (Mandibular dentures are not used for assessments or measures).
- •Maxillary dentures must be considered to be moderately well-fitting at the screening visit. (Kapur Index, Olshan Modification: retention score >2, stability score >2).
- •Maxillary dentures must be considered to be well-made based on design and construction criteria specified in the protocol.
排除标准
- •Women who are breast-feeding, are known to be pregnant or who are intending to become pregnant over the duration of the study.
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •Previous participation in this study or in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- •Recent history (within the last year) of alcohol or other substance abuse.
- •Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participant or undermines the data validity.
- •Implanted with a cardiac pacemaker.
- •Daily doses of medication (example Antibiotics, Inhaled steroids etc.) that might interfere with ability to perform the study according to protocol or might affect the efficacy assessments (as determined by the Investigator/ Examiner).
- •Any clinically significant or relevant oral abnormality that, in the opinion of the Investigator, could affect the participant's participation in the study.
- •Any pre-existing oral irritations.
- •Any recent (within 30 days) gingival /oral surgery.
- •Participants who are unwilling to refrain from smoking, including e-cigarettes and the use of chewing tobacco or other tobacco products for the duration of the study.
- •An employee of the sponsor or the study site or members of their immediate family.
- •An employee of any toothpaste manufacturer or their immediate family.
研究组 & 干预措施
Denture Cleanser Daily Use Period
Participants will be instructed to soak upper arch dentures in the evening in cup of very warm water (150 millilitre [ml]) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 minutes (mins). Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds. Cleaning of upper arch dentures in the morning is not permitted. Lower arch dentures will be cleaned using the participant's normal oral hygiene procedures in the morning and evening. If the participants will have lower removable partial or complete dentures, the soaking of these dentures will be done in a separate cup from the cup provided for soaking the upper denture.
干预措施: Water (Other)
Denture Cleanser Daily Use Period
Participants will be instructed to soak upper arch dentures in the evening in cup of very warm water (150 millilitre [ml]) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 minutes (mins). Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds. Cleaning of upper arch dentures in the morning is not permitted. Lower arch dentures will be cleaned using the participant's normal oral hygiene procedures in the morning and evening. If the participants will have lower removable partial or complete dentures, the soaking of these dentures will be done in a separate cup from the cup provided for soaking the upper denture.
干预措施: Denture Cleanser Daily Use Period (Device)
Denture Cleanser Weekly Use Period
Participants will be instructed to soak upper arch dentures in the evening in cup of very warm water (150 ml) from Day 0 to Day 6 for 15 mins; and in cup of very warm water (150 ml) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds. Cleaning of upper arch dentures in the morning is not permitted. Lower arch dentures will be cleaned using the participant's normal oral hygiene procedures in the morning and evening. If the participants will have lower removable partial or complete dentures, the soaking of these dentures will be done in a separate cup from the cup provided for soaking the upper denture.
干预措施: Denture Cleanser Weekly Use Period (Device)
Denture Cleanser Weekly Use Period
Participants will be instructed to soak upper arch dentures in the evening in cup of very warm water (150 ml) from Day 0 to Day 6 for 15 mins; and in cup of very warm water (150 ml) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds. Cleaning of upper arch dentures in the morning is not permitted. Lower arch dentures will be cleaned using the participant's normal oral hygiene procedures in the morning and evening. If the participants will have lower removable partial or complete dentures, the soaking of these dentures will be done in a separate cup from the cup provided for soaking the upper denture.
干预措施: Water (Other)
结局指标
主要结局
Change From Baseline in Anaerobic Bacteria Microbial Count on Day 7
时间窗: Baseline (Day 0 pre-treatment), Day 7 (post-treatment)
Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated anaerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.
Change From Baseline in Aerobic Bacteria Microbial Count on Day 7
时间窗: Baseline (Day 0 pre-treatment), Day 7 (post-treatment)
Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10-millimeter (mm) filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.
Change From Baseline in Candidal Microbial Count on Day 7
时间窗: Baseline (Day 0 pre-treatment), Day 7 (post-treatment)
Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.
次要结局
- Change From Baseline in Anaerobic Bacteria Microbial Count on Day 3(Baseline (Day 0 pre-treatment), Day 3 (post-treatment))
- Change From Baseline in Aerobic Bacteria Microbial Count on Day 3(Baseline (Day 0 pre-treatment), Day 3 (post-treatment))
- Change From Baseline in Candidal Microbial Count on Day 3(Baseline (Day 0 pre-treatment), Day 3 (post-treatment))