The Impact of Rugae Reproduction on Complete Dentures Patients' Satisfaction
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. 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
      reproduction of their rugae on the anterior palatal area as opposed to a polished 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,
      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 reproduction of their rugae on the anterior palatal area
      as opposed to a polished 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
      two types of palatal contours after using each type for one month post-delivery.
    

Intervention name(s): Addition of palatal rugae to the complete denture surface; The removal of the palatal rugae from the complete denture surface
Intervention type(s): Other; Other
Intervention description(s): The addition and reproduction of the patient's own palatal rugae to the complete maxillary denture palatal surface.; The removal of the palatal rugae from the complete maxillary denture palatal surface to become a smooth surface
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients will randomly be allocated to either group A/B or B/A. Group A: Patients receiving a reproduction of their palatal rugae Group B: Patients receiving a smooth palatal surface.
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 periodthe same process will be repeated.
Masking: Single (Outcomes Assessor)
Primary purpose: Other