Denture Retention Clinical Trial
Official title:
A Clinical Study Assessing Maximum Maxillary Bite Force When Using a Novel Denture Adhesive Compared to Using No-adhesive
The purpose of this study is to investigate the hold properties of an investigational denture adhesive using an established methodology called the maximum incisal bite force (BF), and Kapur-Olshan (KO) index for denture retention and stability. The effects of hot drinks and two questionnaires relating to participants' perception will also be assessed for the investigational denture adhesive.
This study will be a single-centre, controlled, randomized, single blind, 4-treatment, 4-period, cross-over study to evaluate maximum maxillary bite force in a population of full maxillary denture wearers. This study consists of 5 visits (1 screening visit and 4 treatment periods including minimum washout period of 2 days between treatment visits). Participant's maxillary and mandibular dentures will be assessed for retention and stability using KO index and whether they are well made. Participants will be randomized to one of the 4 treatment groups i.e. No adhesive, Super Poligrip Free (SPF), Investigational Adhesive and Investigational Adhesive + Hot drink arm group and will undergo an oral soft tissue (OST) and Oral Hard Tissue (OHT) examination. Participants who will meet all the inclusion and no exclusion criteria will continue the study. Participants will complete the BF measurement, KO assessment, OST, OHT examination and participants 'perception questionnaire as per the schedule. ;
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