Clinical Efficacy of Three Experimental Toothpastes Using an in Situ Caries Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks
研究概览
简要总结
This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period crossover, incomplete block design, in situ caries study in healthy adults who wear a removable bilateral mandibular partial denture. The denture will be modified to accommodate 4 gauze-covered specimens of human dental enamel (4x3mm) that have been previously demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type will be used with each participant). After 14 days of twice daily product use off-site, the 2 S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion specimens removed at the study site after a further 14 days of product use. To determine the remineralization ability of the treatments, all specimens will be analyzed by transverse microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by quantitative light fluorescence (QLF).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Demonstrates understanding of the study.
- •Aged 18 to 85 years.
- •Understands and is willing, able and likely to comply with all study procedures and restrictions.
- •Has good general health (in the opinion of the investigator or medically qualified designee).
- •A salivary flow-rate in the range of normal values (unstimulated whole saliva flow- Rate ≥ 0.2 g/minute (min); gum base stimulated whole saliva flow-Rate ≥ 0.8 g/min).
- •Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.
- •Have no current active caries or periodontal disease and all restorations in a good state of repair.
- •Willing and capable of brushing their natural teeth with the lower partial denture in place.
排除标准
- •Pregnant or breast feeding women.
- •Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
- •Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
- •Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
- •Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- •Have received a professional fluoride treatment within 14 days of randomization to the first treatment.
- •Recent history (within the last year) of alcohol or other substance abuse.
研究组 & 干预措施
Experimental Dentifrice1
Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.
干预措施: 0.425 % w/w phytate,1150ppm F (Drug)
Experimental Dentifrice 2
Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.
干预措施: 0.85 % w/w phytate,1150ppm F (Drug)
Experimental Dentifrice 3
Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.
干预措施: 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F (Drug)
Reference Product 1
Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.
干预措施: 0 ppm F (Other)
Reference Product 2
Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.
干预措施: 1150ppm F (Drug)
Reference Product 3
Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.
干预措施: 0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F (Drug)
结局指标
主要结局
Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks
时间窗: Baseline upto 2 weeks
SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): \[D-R/D-B\]\*100.
次要结局
- % SMHR of 0.85% Phytate Compared to 0% Phytate, in Presence of 1150ppm Fluoride and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.85% Phytate(Baseline upto 2 weeks)
- Enamel Fluoride Uptake (EFU) of All Study Formulation Variables(At Week 4)
- Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks(Baseline upto 4 weeks)
- TMR Δm Value of 0.85% Phytate Compared to 0% Phytate, in the Presence of 1150ppm F and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.85% Phytate(Baseline upto 4 weeks)