Impact of Different Palatal Contour Designs on Patients' Satisfaction and Oral Health Related Quality of Life
Condition: Edentulous Jaw
MeSH terms: Jaw, Edentulous
Study type: Interventional

Summary: 
      The palatal rugae, refer to asymmetrical and irregular elevations of the mucosa located in
      the anterior third of the palate, on each side of the median palatal raphe and behind the
      incisive papilla. The lack of the rugae area on the polished areas of the dentures has been
      suggested to impact phonetics in denture patients due to lack of tactile feedback. Therefore,
      the aim of this randomized crossover clinical trial was to compare patients' reported
      satisfaction with their complete dentures and oral health related quality of life, when
      provided with a denture with a rough palatal surface in the rugae area compared with a
      polished palatal surface or an open palatal surface.
    

Detailed description: 
      The use of dentures could impact the patients' phonetics which could impact their speech.
      Phonetics could be affected by multiple factors such as having a proper occlusal vertical
      dimension, proper occlusal plane, correctly positioned anterior and posterior teeth, and
      adequate contouring of the palatal surface. The lack of the rugae area on the polished areas
      of the dentures has been also suggested to impact phonetics in denture patients.

      The palatal rugae, refer to asymmetrical and irregular elevations of the mucosa located in
      the anterior third of the palate, on each side of the median palatal raphe and behind the
      incisive papilla. In addition to enhancing phonetics, the precise reproduction of the rugae
      in the complete dentures has been suggested to enhance mastication, deglutition and better
      taste perception. However, these suggestions were based on empirical evidence.

      Many studies have described methods for replicating the patients rague on complete dentures
      or modifying the palatal area, however there are no clinical study to ascertain or negate the
      impact of this procedure. Therefore, the aim of this randomized crossover clinical trial was
      to compare patients' reported satisfaction with their complete dentures and oral health
      related quality of life, when provided with a denture with a rough surface in their rugae on
      the anterior palatal area as opposed to a polished palatal surface or an open palatal
      surface. The null hypothesis was that there would be no difference in patients' reported
      satisfaction rate using visual analogue scale (VAS) and Oral Health Impact Profile for
      Edentulous Patients (OHIP-EDENT) Questionnaire response between the three types of palatal
      contours after using each type for two month post-delivery.
    

Intervention name(s): Polished palatal surface; Roughened palatal surface; Opened palatal surface
Intervention type(s): Other; Other; Other
Intervention description(s): Polishing of the anterior palatal surface using a polisher; Roughening of the anterior palatal surface using a sandblaster; Opening of the anterior palatal surface using acrylic bur
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients will randomly be allocated to either group P/R/O. Group P: Patients receiving a smooth palatal surface. Group R: Patients receiving a rough surface in the rugae area. Group O: Patients receiving an open surface in the rugae area
After insertion, all participants will be followed up for a minimum of 1 week to correct any issues with the dentures and eliminate patient complaints.
All patients will be recalled at 2 month after insertion to answer questions using the VAS and to fill out the Oral Health Impact Profile-20 EDENT (OHIP-EDENT), and receive the other type of palatal contour.
After the second and third period the same process will be repeated.
Masking: Single (Outcomes Assessor)
Primary purpose: Other