Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT02780661
Eligibility Criteria:
Inclusion Criteria:
* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
* Aged between 18 and 84 years inclusive.
* Good general and mental health with, in the opinion of the Investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination; Absence of any condition that could affect the participant's safety or wellbeing or their ability to understand and follow study procedures and requirements.
* Maxillary Arch: Completely edentulous maxillary arch restored with a conventional full acrylic based upper complete denture.
* Mandibular Arch: Dentate, partial or full edentulous mandibular arch. Partial or full edentulous arch may be restored with a stable complete, partial or implant supported denture. (Mandibular dentures are not used for assessments or measures).
* Maxillary dentures must be considered to be moderately well-fitting at the screening visit. (Kapur Index, Olshan Modification: retention score \>2, stability score \>2).
* Maxillary dentures must be considered to be well-made based on design and construction criteria specified in the protocol.
Exclusion Criteria:
* Women who are breast-feeding, are known to be pregnant or who are intending to become pregnant over the duration of the study.
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
* Previous participation in this study or in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
* Recent history (within the last year) of alcohol or other substance abuse.
* Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participant or undermines the data validity.
* Implanted with a cardiac pacemaker.
* Daily doses of medication (example Antibiotics, Inhaled steroids etc.) that might interfere with ability to perform the study according to protocol or might affect the efficacy assessments (as determined by the Investigator/ Examiner).
* Any clinically significant or relevant oral abnormality that, in the opinion of the Investigator, could affect the participant's participation in the study.
* Any pre-existing oral irritations.
* Any recent (within 30 days) gingival /oral surgery.
* Participants who are unwilling to refrain from smoking, including e-cigarettes and the use of chewing tobacco or other tobacco products for the duration of the study.
* An employee of the sponsor or the study site or members of their immediate family.
* An employee of any toothpaste manufacturer or their immediate family.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT02780661
Study Brief:
Protocol Section:
NCT02780661