Last updated: 09/28/2021 05:40:04
Efficacy evaluation of Denture Adhesive creams for Denture Retention and Bite Force improvement using pooled data from GSKCH clinical studies
GSK study ID
213380
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A Post-hoc Pooled Analysis of GSK CH Clinical Data Investigating the Efficacy of Denture Adhesive creams containing PMV/MA &CMC on Denture Retention and Bite Force
Trial description: The aim of this study is to compile aggregate data from GSK CH clinical studies to evaluate efficacy of denture adhesive creams containing 30 percent (%) poly methyl vinyl /maleic anhydride (PMV/MA) & 24% carboxymethylcellulose (CMC) on denture hold and bite force overall and within sub-groups, over 12-hour period. The pooled analysis was planned and conducted after completion of nine independent studies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force (BF) Until Maxillary Denture Dislodgement
Timeframe: Up to 12 hours
Secondary outcomes:
Area Over Baseline (AOB) at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal Bite Force (BF) Until Maxillary Denture Dislodgement
Timeframe: At 0.5, 1, 3, 6 and 9 hours
Raw Mean Bite Force (BF) Measurement at 0.5, 1, 3, 6, 9 and 12 Hours
Timeframe: At 0.5, 1, 3, 6, 9 and 12 hours
Change From Baseline in Raw Bite Force (BF) Measurement up to 0.5, 1, 3, 6, 9 and 12 Hours
Timeframe: Up to 0.5, 1, 3, 6, 9 and 12 Hours
Interventions:
Other: 30% PVM/MA & 24% CMC denture adhesive cream
Enrollment:
322
Observational study model:
Other
Primary completion date:
2021-19-05
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Denture Retention
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2020 to May 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Clinical studies conducted by GSK CH, including: Access to study protocols, study reports, and access to anonymized individual information sources/ study data.
- Study design and participant inclusion criteria in agreement with pre-defined study selection criteria:
- Studies that do not meet pre-defined study inclusion criteria.
Inclusion and exclusion criteria
Inclusion criteria:
- Clinical studies conducted by GSK CH, including: Access to study protocols, study reports, and access to anonymized individual information sources/ study data.
- Study design and participant inclusion criteria in agreement with pre-defined study selection criteria:
- a) Participant eligibility based on study inclusion criteria: 1. Completely edentulous maxillary arch. 2. Well-made complete dentures according to the de-sign and construction criteria used in GSK studies. 3. Qualifying maxillary incisal bite readings (without adhesive) less than or equal to 9 lbs. at the Screening and subsequent pre-treatment baseline bites.
- b) Raw bite force data available.
- c) Comparable treatment (30% PVM/MA & 24% CMC denture adhesive creams).
Exclusion criteria:
- Studies that do not meet pre-defined study inclusion criteria.
Trial location(s)
Location
GSK Investigational Site
Weybridge, Surrey, United Kingdom
Status
Recruitment Complete
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2021-19-05
Actual study completion date
2021-19-05
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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