This clinical investigation will evaluate the effectiveness, tolerability and safety of two denture fixative creams versus no fixative control
A single-centre, randomised, 3-way cross-over, clinical investigation comparing the performance of two denture fixative versus no denture fixative control in full denture wearers and an exploratory sub study in partial denture wearers. The study will assess the performance and tolerance of two denture fixative cream formulations (Paraffin based and Polydecene based) when applied to full dentures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
71
Denture fixative applied in strips to secure dentures in place
Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds
Leeds, West Yorkshire, United Kingdom
Denture Retention Assessment at 1hour
To assess denture retention of full maxillary arch after 1 hour with and without denture fixative using the Modified (Olshan) Kapur Index. Retention will be measured on score of 0-5 to assess the nature of resistance offered by the denture/denture fixative to vertical force. The higher the score, the higher the retention ability of the denture and fixative.
Time frame: 1 hour after denture fixative application or no fixative control
Denture Retention Assessment at 5minutes and 30minutes
To assess denture retention in full maxillary arch (and mandibular arch in fully edentulous participants) using the Modified (Olshan) Kapur Index at 5 and 30 minutes. Retention will be measured on score of 0-5 to assess the nature of resistance offered by the denture/denture fixative to vertical force. The higher the score, the higher the retention ability of the denture and fixative.
Time frame: 5mins and 30 mins after denture fixative application or no fixative control
Denture Stability at 5minutes, 30minutes and 1hour
To assess denture stability in full mandibular arch (if present) using the Modified (Olshan) Kapur Index as separate scores at 5minutes, 30 minutes and 1 hour.
Time frame: 5mins and 30 mins after denture fixative application or no fixative control
Denture Hold Assessment
To assess denture hold (retention and stability) at ≤2 hours, 2 to 4 hours, 4 to 6 hours and 6 to 12 hours using the Modified (Kulak) Kelsey questionnaire compared to no fixative control
Time frame: ≤2 hours, 2 to 4 hours, 4 to 6 hours and 6 to 12 hours after denture fixative application or no fixative control
Gum Comfort Assessment
To assess gum comfort using the Gum Comfort questionnaire comparing denture fixative to no fixative control over periods of 4 days (change in overall mean score and individual responses)
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Time frame: At the end of each participant's day during the 4-day treatment period for each arm
Participant Satisfaction Assessment
To assess participant satisfaction of the denture fixatives using the Modified (Kulak) Kelsey questionnaire compared to no fixative control
Time frame: At the end of each participant's day during the 4-day treatment period for each arm
Oral Health Assessment
To make a clinical assessment of the oral health impact profile of participants using the Oral Health Impact Profile-Edentulous (OHIP-EDENT) questionnaires after 4 days use of each of the dental fixatives administered and no fixative control.
Time frame: To be completed once during the participant's clinic visit on days 2,3,4,5,6,7 and 8 comparing with and without fixative
Bite Force Assessment
To measure Bite force by means of a digital gnathometer to compare the denture fixatives to no fixative control
Time frame: To be completed once during the participant's clinic visit on days 3, 5 and 7