Oral Health-related Quality of Life and Masticatory Function After Using Denture Adhesive and Denture Liner
Condition: Complete Denture; Complete Edentulism
Study type: Interventional
Phase: Phase 3

Summary: 
      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).
    

Detailed description: 
      Participants The eligible participants were CD wearers randomly recruited from patients who
      visited the Prosthodontic clinic at the Faculty of Dentistry, Chulalongkorn University from
      2015 to 2019. The inclusion criteria were patients who had worn removable maxillary and
      mandibular CDs for at least 6 months. The patients who wore a metal-based denture, had a
      history of DA use, had difficulty in responding to the interview, or were unwilling to follow
      the study protocol were excluded from the study.

      Outcomes The primary outcome was OHRQoL determined using the Thai-version of Oral Impacts on
      Daily Performances index. The participants were interviewed whether they had difficulties in
      performing the following 8 daily activities: eat, speak, clean denture and mouth, sleep,
      smile, emotional stability, social contact, and carry out work or housework. The frequency
      and severity of each impact were rated using a five-point Likert scale, and their
      multiplication gave a condition-specific impact score. The overall oral impact score was the
      sum of all 8 activity scores. The prevalence of an oral impact was categorized into absence
      (score = 0) or presence of an oral impact (score > 0). The changes in oral impact score from
      T0 to T1 were categorized into 3 types: decreased (T0 score > T1 score), increased (T0 score
      < T1 score), and remained absent (T0 score = T1 score = 0).

      The secondary outcome was masticatory performance assessed using the multiple sieve method of
      peanut mastication. The participants masticated 3 grams of roasted peanuts for 20 strokes in
      triplicate with a 15-minute resting interval between each test. The comminuted peanut
      particles were dried and sieved through 12 standard test sieves (Test sieve; Retcsh
      Technology GmbH) on a vibrating sieve shaker. A simple linear regression was plotted between
      the cumulative weight and diameter of each sieve test. The median peanut particle size (mm)
      was the sieve diameter through which 50% of the comminuted peanut particles passed. A smaller
      peanut particle size reflected a higher masticatory performance.

      Intervention An external prosthodontist provided a cream-type DA (Polident®, GlaxoSmithKline,
      Ireland), and instructed the participants to use the DA cream once a day in the morning and
      use it throughout the day. They applied the DA onto maxillary and mandibular dentures on the
      tissue surface using a spot method. The participants had to remove the DA and clean the
      denture every day after the last meal by soaking and brushing the CD with liquid soap and a
      soft toothbrush under running tap water. Two gauze pads were used to remove DA from the
      denture and oral mucosa.

      The OHRQoL, masticatory performance, and CD-quality were evaluated at 3-time points:

        1. T0, at baseline before using the DA. The baseline information regarding the outcomes was
           evaluated. Then, the participants underwent a daily 1-month trial of DA use,

        2. T1 (T0 + 1 month), after the 1-month trial period of DA use. The outcomes were evaluated
           with all participants using DA. The external prosthodontist asked the participants to
           choose whether they wanted to continue or discontinue using DA, and

        3. T2 (T0 + 2 months), at 1-month after continuing or discontinuing DA use. At this time,
           some participants used DA during the outcome evaluations, while some did not, depending
           on the patient's decision on DA use.

      A single-blind clinical trial protocol was created. One of the investigators (B.T.) performed
      the outcome assessment who did not notice whether the participants continue using DA.
    

Intervention name(s): denture adhesive (Polident®, GlaxoSmithKline, Ireland)
Intervention type(s): Drug
Intervention description(s): cream-type denture adhesive available as an over-the-counter product in Thailand
Other intervention name(s): Polident
Intervention model: Single Group Assignment
Intervention model description: Before and after intervention, and then allow the participants to decide whether to continue receiving the intervention
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: denture adhesive; oral impact; masticatory function; denture retention; denture stability