Status:
WITHDRAWN
A Clinical Study to Assess Force Required to Dislodge Upper Denture With and Without Use of a Novel Denture Adhesive
Lead Sponsor:
GlaxoSmithKline
Conditions:
Denture Retention
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the hold properties of an investigational denture adhesive using an established methodology called the maximum incisal bite force (BF), and Kapur-Olshan (KO...
Detailed Description
This study will be a single-centre, controlled, randomized, single blind, 4-treatment, 4-period, cross-over study to evaluate maximum maxillary bite force in a population of full maxillary denture wea...
Eligibility Criteria
Inclusion
- 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.
- 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,
- Are well made (according to the well-made assessment).
- Participant with BF measurements which satisfy the following criteria:
- The "qualifying" BF measurements (without adhesive) at V1 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).
Exclusion
- 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 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 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 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 who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
- 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 (i.e., Fosamax, Actonel, Boniva).
- Use of any medication or 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 (e.g. temporomandibular joint \[TMJ\] problems) that, in the opinion of the investigator, could affect the participant's participation in the study.
- A participant clinically identified as having an incisal bite relation or any other tooth abnormality which 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 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 with OST examination findings (at V1) such as stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling which in the opinion of the investigator, would interfere with the conduct of the study.
- A participant who has previously been enrolled in this study.
- Any participant who can't comply with study requirements and/or who would not be able to reliably perform a valid bite at the examiner's discretion.
Key Trial Info
Start Date :
October 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04473521
Start Date
October 4 2020
End Date
January 10 2021
Last Update
January 22 2021
Active Locations (1)
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1
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202