Clinical trial NCT04985747: Impact of Different Palatal Contour Designs on Patients' Satisfaction and Oral Health Related Quality of Life
Official title: The Impact of Different Palatal Contour Designs on Patients' Satisfaction and Oral Health Related Quality of Life; a Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Jaw
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 35
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patients seeking a set of conventional maxillary and mandibular complete dentures at the University of Jordan Hospital, for the first time or as a replacement of their previous dentures.
2. Patients aged between 45 and 80 years old.
3. Patients had been completely edentulous for at least 3 months
4. Patients without severe underlying medical conditions, neuromascular dysfunction, auditory problems, mental conditions, oral pathology, xerostomia, or tied tongue condition.
5. Patients who approved and consented to participation.

Primary outcomes:
measure: 100mm Visual analogue scale of patients' reported overall satisfaction with their dentures
timeFrame: 90 days
Secondary outcomes:
measure: OHIP-EDENT Measure
timeFrame: 90 days
measure: 100mm Visual analogue scale of patients' reported overall satisfaction with their dentures during speaking
timeFrame: 90 days
measure: 100mm Visual analogue scale of patients' reported overall satisfaction with their ability to clean their dentures
timeFrame: 90 days
measure: 100mm Visual analogue scale of patients' reported overall satisfaction with their phonetics
timeFrame: 90 days
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan Hospital
Study officials:
References: