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N/A N=83 Randomized Single-blind Supportive Care

Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress

Denture Retention

Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use — 0.06; 0.08 gram (g) — p=0.0987

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Experimental Denture Adhesive (Device); Reference (Marketed) Denture Adhesive (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Sep 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use
0.06; 0.08 0.0987
SECONDARY
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and on no Adhesive Use
0.07; 0.08
SECONDARY
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and Reference Denture Adhesive
0.07; 0.06
SECONDARY
Composite Kapur (Olshan Modification) Index Scores for Denture Retention and Stability
8.67; 8.84; 8.35; 7.42; 8.11; 6.36
SECONDARY
Kapur (Olshan Modification) Index Scores for Denture Retention
4.80; 4.90; 4.63; 4.05; 4.43; 3.46
SECONDARY
Kapur (Olshan Modification) Index Scores for Denture Stability
3.88; 3.94; 3.72; 3.37; 3.67; 2.90

Summary

In this clinical study, an experimental denture adhesive with a precision tip nozzle was tested to evaluate the relative efficacy to reduce the ingress of food under the denture compared to use of no adhesive or a standard marketed adhesive.

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 85 years inclusive
  • Understands and is willing, able and likely to comply with all study procedures and restrictions
  • Good general and mental health with, in the opinion of the investigator or medically qualified designee:No clinically significant and relevant abnormalities of medical or physical history; Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures
  • A qualifying full denture in both the upper and lower arch
  • Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability Index Sum Score ≥6)
  • Dentures are well made (according to the well-made assessment)
  • Participants must report that they get food trapped under their denture
  • A peanut particle migration rating >0 for both dentures at screening

Exclusion Criteria

  • Women who are known to be pregnant (participant-reported) or who are intending to become pregnant over the duration of the study
  • Women who are breast-feeding
  • Medications, which in the opinion of the investigator, would interfere with the conduct of the study
  • Taking or have taken a bisphosphonate drug for treatment of osteoporosis
  • A serious chronic disease requiring hospitalization
  • History of swallowing difficulties or choking
  • Any condition not previously mentioned that in the investigator's opinion may impair the study evaluation
  • Any condition or medication which, in the opinion of the investigator, is currently causing xerostomia
  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
  • Known allergy to peanuts or any other nut
  • Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
  • Previous participation in this study
  • Recent history (within the last year) of alcohol or other substance abuse
  • OST examination findings such as stomatitis, open sores, lesions, redness or swelling
  • An employee of the sponsor or the study site or members of their immediate family
  • Any participant who, in the opinion of the Investigator, should not participate in the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02928380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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