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NCT05689814
Retention, Stability and Performance Assessment of Denture Fixatives Versus no Fixative Control
Conditions: Dentures
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 90
Sponsor: Reckitt Benckiser Healthcare (UK) Limited
Location: United Kingdom
Summary
This clinical investigation will evaluate the effectiveness, tolerability and safety of two denture fixative creams versus no fixative control
Eligibility Criteria
Inclusion Criteria:Participants with a completely edentulous maxillary [UPPER] arch restored with a conventional full acrylic-based complete denture and dentate, partial, or full edentulous mandibular [LOWER], which may be restored with a stable complete, partial or implant supported dentureFor complete denture wearers, maxillary [UPPER] dentures must be completely removable standard acrylic dentures, which are at least moderately well-fitting at the screening visit (modified (Olshan) Kapur Index: retention score ≥2, stability score ≥2)Male or female participants aged between 18 and 85 years at the time of signing the informed consent formParticipants must have been using dentures daily for at least 6 months prior to the screening visitDentures must have been made in the last 5 years;Dentures must be well-made based on design and construction in the opinion of the clinicianNo clinically significant and relevant abnormalities in medical history or upon oral examinationExclusion Criteria:Female participants who are pregnant as confirmed by a positive pregnancy test (urine) or are lactating (applicable to female participants of childbearing potential)Daily doses of medication that might interfere with the ability to perform the study according to protocol or affect study assessments, for example, bisphosphonates (oral or intravenous) (as determined by the Investigator)Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredientsAny clinically significant or relevant oral abnormality (e.g., temporomandibular joint [TMJ] problems), or recent (within last 6 months) oral surgery / intervention, or oral health concern that, in the opinion of the investigator, could affect the participant's participation in the studyParticipants with maxillofacial defects covered by prostheticsSelf-reported and/or visual manifestations of severe dry mouth (xerostomia) that may affect denture retention in the opinion of the InvestigatorParticipants with oral soft tissue examination findings such as stomatitis, open sores, ulcers, lesions, redness or swelling or associated lymphadenopathy
Source: ClinicalTrials.gov (NCT05689814). StuddyBuddy aggregates publicly available trial information.