A Proof-of-principle Clinical Study Investigating the Efficacy of a Dissolvable Strip in Providing Rapid Relief From Dentinal Hypersensitivity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Change From Baseline in Schiff Sensitivity Score After 10 Minutes
研究概览
简要总结
A proof of principle single-centre, randomized-controlled, examiner-blind, two treatment group study to investigate the efficacy of an experimental 15% w/w dissolvable strip in relieving dentine hypersensitivity (DH) after a single application and up to 4 hours after application compared to no treatment.
详细描述
This was a single-centre, randomized-controlled, examiner-blind, two treatment group (test and no treatment), parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth) study, in healthy participants with at least two sensitive teeth that meet all the criteria at the screening and the baseline pre-treatment visit. Participants were screened for study suitability at screening visit (Visit 1). At Visit 2 (baseline; pre-treatment) 2 non-adjacent accessible teeth (incisors, canines, premolars) in different quadrants of the mouth and separated by at least 2 teeth (or equivalent edentulous space) were identified that demonstrated signs of sensitivity as measured by a qualifying tactile stimulus (Yeaple ≤ 20 gram [g]) and evaporative air assessment (Schiff sensitivity score ≥ 2) on the facial/cervical (ie, labial/buccal) tooth surface. Once the 2 test teeth were selected, the subjects were stratified (by maximum baseline Schiff sensitivity score of the 2 selected test teeth) and randomized to treatment or no treatment. DH was assessed at baseline (pre-treatment), and 10mins, 2 & 4 hours post-treatment.
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)
入排标准
- 年龄范围
- 18 Years 至 65 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 assigned and dated copy of the informed consent form.
- •Aged 18-65 years.
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities of medical history or oral Examination and absence of any condition that would impact on the participants safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- •Understands and is willing, able and likely to comply with all study procedures and restrictions.
- •At Visit 1 (Screening): a) Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years. b) Minimum of 20 natural teeth. c) Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), in different quadrants and separated by at least two teeth (or equivalent edentulous space), that meet all of the following criteria: Signs of facial/ cervical (i.e. labial/ buccal) gingival recession and/or signs of erosion or abrasion (EAR), tooth with MGI score = 0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response) on the facial/ cervical (i.e. labial/ buccal) tooth surface.
- •At Visit 2, Baseline (Pre-treatment): Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) in different quadrants of the mouth and separated by at least two teeth (or equivalent edentulous space), that meet all of the following criteria: Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2) on the facial/ cervical (i.e. labial/ buccal) tooth surface.
排除标准
- •A woman who is known to be pregnant or who are intending to become pregnant over the duration of the study.
- •A women who is 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 (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit and previous participation in this study.
- •Recent history (within the last year) of alcohol or other substance abuse.
- •An employee of the sponsor or the study site or members of their immediate family.
- •Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes and any condition which, in the opinion of the investigator, causes xerostomia (dry mouth).
- •Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing, desensitizing treatment within 8 weeks of Screening (professional sensitivity treatments and non-dentifrice sensitivity treatments), gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening and teeth bleaching within 8 weeks of screening.
- •Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of screening and tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, dental implants, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine. Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator.
- •Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening (Participants will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients).
- •Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs, currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline and daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
- •Any participant who, in the judgment of the investigator, should not participate in the study.
研究组 & 干预措施
Test Product: Dissolvable polymer strip containing Novamin
In this arm, participants received an experimental dissolvable polymer strip containing 15 % weight/weight (w/w) calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
干预措施: Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate) (Device)
Reference Product: No treatment/product
In this arm, participants did not receive any treatment/product.
结局指标
主要结局
Change From Baseline in Schiff Sensitivity Score After 10 Minutes
时间窗: At baseline (pre-treatment) and 10 minutes post-treatment: Day 1 of the study
The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test tooth, using the Schiff Sensitivity Scale as follows: 0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
次要结局
- Change From Baseline in Schiff Sensitivity Score After 2 and 4 Hours(At Baseline (pre-treatment), 2 and 4 hours post-treatment: Day 1 of the study)
- Change From Baseline in Tactile Threshold After 10 Minutes, 2 Hours and 4 Hours(At Baseline (pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study)
- Change From Baseline in Numerical Rating Scale (NRS) Scores After 10 Minutes, 2 Hours and 4 Hours(At baseline(pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study)