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NCT04942262

Oral Health-related Quality of Life and Masticatory Function After Using Denture Adhesive and Denture Liner

Completed Phase 3 Last updated 28 June 2021
What this trial tests

Phase 3 trial testing denture adhesive (Polident®, GlaxoSmithKline, Ireland) in Complete Denture in 80 participants. Completed in 30 April 2020.

Timeline
31 January 2019
Primary endpoint
17 January 2020
30 April 2020

Quick facts

Lead sponsorChulalongkorn University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment80
Start date31 January 2019
Primary completion17 January 2020
Estimated completion30 April 2020
Sites1 location across Thailand

Drugs / interventions tested

Conditions studied

Sponsor

Chulalongkorn University

Who can join

Adults 40 to 90, any sex, with Complete Denture or Complete Edentulism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

80 complete denture (CD) wearers participated in the quasi-experimental study. Two outcomes were: 1) oral health-related quality of life (OHRQoL) assessed using the Oral Impacts on Daily Performances index, and 2) masticatory performance, determined by a peanut particle size after 20-stroke mastication. Denture retention and stability were evaluated using the Chulalongkorn University (CU)-modified Kapur method to classify the CD into acceptable or unacceptable quality. Data were collected at 3-time points: 1) at baseline (T0), 2) after a 1-month trial of denture adhesive (DA) use (T1), at which time the participants decided whether to continue using DA, and 3) 1-month after continued or discontinued using DA (T2).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Decision to use denture adhesive in complete denture wearers after one-month run-in period: A quasi-experimental study.
    Limpuangthip N, Tumrasvin W, Thongyoi B. · · 2022 · PMID 36454894 · DOI 10.1371/journal.pone.0276760

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