NCT05173974已完成3 期
A Randomized, Single-Blind Clinical Study Assessing the Maximum Maxillary Bite Force When Using Two Novel Denture Adhesives Compared to Using No-Adhesive
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- HALEON
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force
研究概览
简要总结
The purpose of this study is to investigate the hold properties of two experimental denture adhesives using established maximum incisal BF methodology.
详细描述
This will be a single-centre, controlled, randomized, single-blind (with respect to the examiner performing the incisal BF measurements), 4-treatment, 4- period, cross-over study to evaluate the maximum maxillary BF in a population of full maxillary denture wearers. A currently marketed denture adhesive will be used as a positive control, whilst use of no adhesive will be employed as a negative control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 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
- •Participant 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.
- •A participant who is willing and able to comply with scheduled visits, and other study procedures.
- •A participant 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.
- •A participant with a completely edentulous maxillary arch restored with a conventional maxillary full denture with an acrylic base. The maxillary denture prosthesis must fulfil all of the following:
- •At least moderately well-fitting (Kapur Index, Olshan Modification: retention score Greater than or equal to (>=)2, stability score >=2) at the Screening (V1) visit,
- •Is well made (according to the well-made assessment).
- •A participant with BF measurements which satisfy all the following criteria:
- •The qualifying BF measurements (without adhesive) at V1 (Screening) must be less than or equal to (=<) 9lbs.
- •At least 2 of the 4 qualifying BF measurements (without adhesive) at V1 (Screening) must be reproducible (within +-2lbs).
- •The Baseline BF measurement (without adhesive) at V2-5 must be <=9lbs.
- •The Baseline BF measurement (without adhesive) at V2-5 and at least 1 of the 3 practice BF measurements must be within +-2lbs of each other.
- •A participant who is dentate in the mandibular arch or has a partial or full denture in the mandibular arch that is:
- •sufficiently stable, in the opinion of the investigator, to enable the bite force determination to be performed.
- •well made (according to the well-made assessment).
排除标准
- •A participant who is 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 GlaxoSmithKline Consumer Healthcare (GSK CH) 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 Visit 1 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 experimental 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 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 the study materials (or closely related compounds) or any of their stated ingredients.
- •A participant unwilling or unable to comply with the Lifestyle Considerations.
- •A participant who is currently taking or has taken a bisphosphonate drug (that is (i.e.), Fosamax, Actonel, Boniva).
- •A participant who uses any medication or has a condition (e.g. insulin dependent diabetes) that, in the opinion of the investigator, would interfere with the conduct of the study.
- •A participant who has any clinically significant or relevant oral abnormality (for example (e.g.) temporomandibular joint [TMJ] problems or tooth abnormalities) that, in the opinion of the investigator, could affect the BF measurements or participant safety.
- •A participant who has any condition or medication which, in the opinion of the investigator, is currently causing xerostomia or which could interfere with the conduct of the study.
- •A participant with a recent history (within the last year) of alcohol or other substance abuse.
- •A participant with Oral soft tissue (OST) examination findings (at V1) such as stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling which in the opinion of the investigator, could interfere with the conduct of the study.
- •A participant who has previously been enrolled in this study.
- •A participant who is unable to comply with study requirements and/or who is not able to reliably perform a valid bite at the examiner's discretion.
- •A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
结局指标
主要结局
Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force
时间窗: Baseline and up to 12 hours
Natural logged incisal Bite Force (BF) measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-12 was used to assess the incisal BF and defined as (Area under the Curve \[AUC\]0-12) divided by 12 minus baseline BF (pounds \[lbs\]). AUC was calculated from 0 to 12 hours using the trapezoid method; denoted as AUC 0-12. This transformation was carried out to return the measurement to the same scale as the original observation. AOB 0-12 was analyzed for each of the three treatments in comparison to no denture adhesive treatment group. Higher values of AOB 0-12 demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment).
次要结局
- Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF(Baseline, at 0.5, 1, 3, 6 and 9 hours)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
To Evaluate Oral Health and Quality of Life Associated With Use of a Denture AdhesiveDenture RetentionNCT03807700GlaxoSmithKline119
已完成
不适用
A Study to Investigate a Method to Measure Food Occlusion by Denture Adhesives in Denture WearersDenture RetentionNCT03345108GlaxoSmithKline48
已完成
4 期
A Study to Investigate Food Occlusion Efficacy of a Denture Adhesive in Denture WearersDenture RetentionNCT03709810GlaxoSmithKline49
已完成
不适用
A Study to Determine the Efficacy of a Denture Adhesive to Seal Out Food Particles From Under the Mandibular Partial DenturePartial DentureNCT05908890Procter and Gamble29
已完成
不适用
Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical LesionsNon Carious Cervical LesionNCT04756349Universidade Federal do Para18