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Compares treatment options for Denture Retention
Official title A Clinical Study to Assess the Effectiveness of Use of Three Experimental Denture Adhesives Compared to Using No-Adhesive
ClinicalTrials.gov ID: NCT07496164
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of...
- 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...
- A participant with a completely edentulous maxillary arch restored with a conventional maxillary full denture with an acrylic base.
You likely can't join if
- 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...
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to...
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.