An 8-Week, Randomised, Controlled, Double-Blind, Clinical Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- HALEON
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Change from Baseline in Schiff Sensitivity Score at Week 8
研究概览
简要总结
The primary purpose of this study is to demonstrate the clinical efficacy of Test Toothpaste in reducing dentin hypersensitivity (DH) to an evaporative (air) stimulus, compared to a sodium fluoride reference toothpaste, after 8 weeks twice daily use.
详细描述
This will be a single centre, 8-week, randomised, controlled, double-blind, 2-treatment arm, parallel group, stratified study in healthy participants with DH. Participants who meet the required study criteria at Screening and Baseline will be randomised to one of two treatments: a 5% CSPS toothpaste (Test Toothpaste) or a regular sodium fluoride toothpaste (Reference Toothpaste). Sufficient participants will be screened to ensure approximately 192 participants are randomised to investigational products (approximately 96 participants per treatment group) and approximately 172 participants complete the study (approximately 86 participants per treatment group).
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
- Double (Participant, 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
- •Participant provision of signed and dated informed consent before any study procedures are performed.
- •Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions, and other study procedures.
- •Participant is in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in self-reported medical history, or upon oral examination, that would impact their safety or wellbeing, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements.
- •Screening (Visit 1): Participant must have
- •History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
- •Good general oral health, with a minimum of 20 natural teeth.
- •Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all the following criteria:
- •Exposed dentine due to facial/cervical erosion, abrasion, or gingival recession (EAR).
- •Modified Gingival Index (MGI)= 0 directly adjacent to the exposed dentine (i.e., the test area only).
- •Clinical mobility=
- •Clinically confirmed DH to both tactile and evaporative (air) stimuli: Qualifying tactile threshold less than or equal to (<=) 20g and Qualifying Schiff sensitivity score more than or equal to (>=)
- •Baseline (Visit 2, Pre-Treatment)
- •Participant must have a minimum of two non-adjacent, accessible teeth (incisors, canines, premolars), in different quadrants, with clinically confirmed DH to both tactile and evaporative (air) stimuli at both Screening (Visit 1) and Baseline (Visit 2).
- •Tactile threshold <= 20g at Screening and Baseline.
- •Schiff sensitivity score >= 2 at Screening and Baseline.
- •The clinical examiner will select two 'test teeth' from those which meet the tactile threshold and Schiff sensitivity score inclusion criteria at both Screening and Baseline.
排除标准
- •Participant is an employee of the investigator site directly involved in the conduct of the study, or an employee of the investigator site otherwise supervised by the investigator, or a member of their immediate family.
- •Participant is an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
- •Female participant who is pregnant or intending to become pregnant during the study (self-reported).
- •Female participant who is breastfeeding (self-reported).
- •Participant with known or suspected intolerance or hypersensitivity to the study products, any of their stated ingredients or closely related compounds (self-reported).
- •Participant with a recent history (within the last year) of alcohol or other substance abuse (self-reported).
- •Participant is participating in or has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of Screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study.
- •Participant has participated in a tooth sensitivity study within 8 weeks of Screening (Visit 1).
- •Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used such a product within 8 weeks of Screening (Visit 1).
- •Participant takes daily doses of medications/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (for example, analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
- •Screening (Visit 1): Participant has taken antibiotics in the 2 weeks prior to Screening (Visit 1).
- •Baseline (Visit 2): Participant has taken antibiotics in the 2 weeks prior to Baseline (Visit 2), that is, during the acclimatization period.
- •Participant takes daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
- •Participant requires antibiotic prophylaxis for dental procedures.
- •Participant has had professional tooth de-sensitizing treatment within 8 weeks of Screening (Visit 1).
- •Participant has had a tooth bleaching procedure within 8 weeks of Screening (Visit 1).
- •Participant has had dental prophylaxis or supragingival professional mechanical plaque removal (PMPR) within 4 weeks of Screening (Visit 1).
- •Participant has had treatment for periodontal disease (including surgery) within 12 months of Screening (Visit 1).
- •Participant has had subgingival instrumentation within 3 months of Screening (Visit 1).
- •Participant with gross periodontal disease.
- •Participant with a tongue or lip piercing in the area of the test teeth.
- •Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy.
- •Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
- •Participant with multiple dental implants which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
- •Participant has had orthodontic treatment (fixed or removable orthodontic braces/bands) within 6 months of Screening (Visit1).
- •Participant with a fixed or removable orthodontic retainer which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes (e.g., Participant who is an intermittent user of a removable orthodontic retainer). Note: Teeth involved in a fixed orthodontic retainer may be used as 'test teeth' if, in the opinion of the investigator or dentally qualified designee, their selection would not impact study outcomes.
- •Specific Dentition Exclusions for 'Test teeth':
- •Tooth with evidence of current/recent caries.
- •Tooth with (self-reported) treatment for decay within 12 months of Screening (Visit 1).
- •Tooth with exposed dentine and deep, defective, or facial restorations.
- •Tooth with a full crown or veneer.
- •Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
- •Sensitive tooth with contributing etiologies other than EAR to exposed dentine.
- •Sensitive tooth not expected to benefit from use of an anti-sensitivity toothpaste, in the opinion of the investigator or dentally qualified designee.
- •Participant has previously been enrolled in this study.
- •Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
研究组 & 干预措施
Test Toothpaste
Participants will dose the toothbrush with a ribbon of Test Toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning & evening), for approximately 56 days.
干预措施: Test Toothpaste (Device)
Reference Toothpaste (Negative Control)
Participants will dose the toothbrush with a ribbon of Reference Toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning & evening), for approximately 56 days.
干预措施: Regular Fluoride Toothpaste (Other)
结局指标
主要结局
Change from Baseline in Schiff Sensitivity Score at Week 8
时间窗: Baseline and Week 8
Evaporative (air) sensitivity will be assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0 to 3, where 0 equal to (=) Did not respond to air stimulation; 1= Responded to air stimulus but did not request discontinuation of stimulus; 2= Responded to air stimulus and requested discontinuation or moved from stimulus; 3= Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score will be derived as mean score for the two 'Test Teeth' selected at Baseline by the examiner. Change from Baseline will be calculated by subtracting Baseline score from Week 8 score. Lower score indicates improvement.
次要结局
- Change from Baseline in Tactile Threshold gram (g) at Week 8(Baseline and Week 8)
- Change from Baseline in Schiff Sensitivity Score at Weeks 2 and 4(Baseline, Week 2 and Week 4)
- Change from Baseline in Tactile Threshold (g) at Weeks 2 and 4(Baseline, Week 2 and Week 4)