A 4-Week Randomised, Controlled, Examiner-blind, Clinical Study Investigating the Efficacy of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health
概览
- 阶段
- 不适用
- 干预措施
- Test toothpaste
- 疾病 / 适应症
- Dental Plaque
- 发起方
- HALEON
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Mean Bleeding Index (BI) at Week 4
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
The aim of this 4-week clinical study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2), 0.3% Zinc Chloride (ZnCl2) and 1% Alumina, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste (negative control) in participants with plaque-induced mild to moderate gingivitis.
详细描述
This will be a single-center, 4 weeks, randomized, controlled, examiner-blind, 2 treatment arms, stratified, parallel group design clinical study, investigating gingival health and supra-gingival plaque reduction on healthy participants after using an experimental toothpaste containing 0.454% SnF2, 0.3% ZnCl2 and 1% Alumina. Sufficient participants will be screened so that at least 160 participants are randomized (approximately 80 per group) to ensure approximately 144 (approximately 72 per group) evaluable participants complete the entire study.
研究者
入排标准
入选标准
- •Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- •Biological sex at birth was male or female.
- •Aged 18 to 70 years inclusive, at the signing of the informed consent.
- •Willing and able to comply with scheduled visits, treatment plan, saliva sample collection, study restrictions, Lifestyle Considerations and other study procedures.
- •In good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- •Participant oral health that meets all the following:
- •At Screening (Visit 1):
- •Participant with at least 20 natural, permanent teeth, (excluding 3rd molars).
- •Participant with at least 40 evaluable surfaces for MGI, BI, and TPI.
- •A healthy participant with mild to moderate plaque-induced gingivitis in the opinion of the clinical examiner.
排除标准
- •An employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
- •A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- •A participant with, in the opinion of the investigator (or medically qualified designee), an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- •A participant who has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study outcomes and/or participant safety.
- •A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
- •A participant who is breastfeeding.
- •A participant with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients.
- •A participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
- •A participant who is a current smoker or an ex-smoker (including vaper) who stopped within 6 months of Screening.
- •A participant who is using smokeless forms of tobacco (for example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
研究组 & 干预措施
Test Toothpaste
Participants will brush their teeth with full ribbon of test toothpaste on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
干预措施: Test toothpaste
Reference Toothpaste (Negative Control)
Participants will brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
干预措施: Colgate Cavity Protection Toothpaste
结局指标
主要结局
Mean Bleeding Index (BI) at Week 4
时间窗: Week 4
The BI is an invasive assessment of gingival bleeding. To perform the bleeding assessment, a round-end probe is inserted approximately 1 millimeter (mm) into the gingival sulcus (at approximately 60 degrees) and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. Presence/absence of gingival bleeding is assessed for 30 seconds after probing. BI will be assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, six sites per tooth and scored on 3-points scale ranging from 0 to 2, where 0= Absence of bleeding on probing, 1= Bleeding observed within 30 seconds of probing, 2= Bleeding observed immediately on probing. Mean BI will be calculated by taking the average over all tooth sites assessed for a participant. Lower score indicates improvement in the symptoms.
次要结局
- Mean Number of Bleeding Sites (NBS) at Week 4(Week 4)
- Mean Modified Gingival Index (MGI) at Week 4(Week 4)
- Mean Overall Turesky Plaque Index (TPI) at Week 4(Week 4)
- Mean Interproximal TPI at Week 4(Week 4)