A Clinical Study to Assess the Effectiveness of Use of Three Experimental Denture Adhesives Compared to Using No-Adhesive

Официальное название

A Randomized, Controlled, Single-Blind, Cross Over Clinical Study Assessing the Maximum Maxillary Bite Force When Using Three Denture Adhesives Compared to Using No-Adhesive

Обзор

The aim of the proposed clinical study is to investigate the efficacy of three experimental denture adhesive creams to improve denture hold over a period of 13 hours.

Подробное описание

This will be a single-center, controlled, randomized, single blind, 5 treatment-period, cross-over study to evaluate maximum maxillary bite force in a population of full maxillary denture wearers. A sufficient number of participants will be screened to randomize up to 60 participants to ensure at least 54 evaluable participants complete the entire study.

Вмешательства

• Устройство Experimental Denture Adhesive 1
  Denture adhesive cream
• Устройство Experimental Denture Adhesive 2
  Denture adhesive cream
• Устройство Experimental Denture Adhesive 3
  Denture adhesive cream
• Устройство Poligrip Power Hold + Seal
  Denture adhesive cream

Первичные конечные точки

• Area Over Baseline (AOB) in Bite Force Over 13 Hours (AOB0-13) to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Versus [Vs] No Denture Adhesive) [Срок оценки: Baseline and up to 13 hours]

Вторичные конечные точки (3)

• AOB0-13 to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control) [Срок оценки: Baseline and up to 13 hours]
• AOB in Bite Force to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs No Adhesive) [Срок оценки: Baseline and up to 1, 3, 6, 9, 12 hours]
• AOB in Bite Force to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control) [Срок оценки: Baseline and up to 1, 3, 6, 9, 12 hours]

Критерии участия

Критерии включения

• 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 male or female participant who, at the time of screening, is aged 18+ years.
• 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.
• 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).

Критерии исключения

• 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 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 Visit 1 and/or during study participation.
• A participant who is pregnant (self-reported) or intending to become pregnant or who is breastfeeding over the duration of the study.
• 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 described in this protocol.
• A participant who is currently taking or has taken a bisphosphonate drug.
• A participant who uses any medication or has a condition that, in the opinion of the investigator, would 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 who has previously been enrolled in this study.
• A participant who, in the opinion of the investigator, is unable to comply with study requirements and/or who is not able to reliably perform a valid bite.
• A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• Oral Health Research Institute (OHRI) — Indianapolis

Идентификаторы

NCT: NCT07496164 · 400325

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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