Impact of Different Palatal Contour Designs on Patients' Satisfaction and Oral Health Related Quality of Life

Edentulous Jaw Clinical Trial

Official title:

The Impact of Different Palatal Contour Designs on Patients' Satisfaction and Oral Health Related Quality of Life; a Crossover Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04985747
• Other study ID #: UJordan2
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: July 2023
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous

Intervention

Other:
• Polished palatal surface
Polishing of the anterior palatal surface using a polisher
• Roughened palatal surface
Roughening of the anterior palatal surface using a sandblaster
• Opened palatal surface
Opening of the anterior palatal surface using acrylic bur

Locations

Country	Name	City	State
Jordan	University of Jordan Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	100mm Visual analogue scale of patients' reported overall satisfaction with their dentures	Patients overall satisfaction rate using visual analogue scale (a measurement instrument represented in a straight horizontal line of fixed length, 100 mm. The ends are defined as the extreme limits of the parameter to be measured (satisfied and unsatisfied). Orientated from the left 'best' to the right 'worst').	90 days
Secondary	OHIP-EDENT Measure	Patients reported oral health related quality of life using the Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) Questionnaire; The OHIP-EDENT index has 20 items and uses a 0-5 scale where 0 is never and 5 is always. The minimum overall score can be 20 and maximum 100.	90 days
Secondary	100mm Visual analogue scale of patients' reported overall satisfaction with their dentures during speaking	Patients overall satisfaction rate during speaking using visual analogue scale (a measurement instrument represented in a straight horizontal line of fixed length, 100 mm. The ends are defined as the extreme limits of the parameter to be measured (satisfied and unsatisfied). Orientated from the left 'best' to the right 'worst').	90 days
Secondary	100mm Visual analogue scale of patients' reported overall satisfaction with their ability to clean their dentures	Patients overall satisfaction rate with their ability to clean their dentures using visual analogue scale (a measurement instrument represented in a straight horizontal line of fixed length, 100 mm. The ends are defined as the extreme limits of the parameter to be measured (satisfied and unsatisfied). Orientated from the left 'best' to the right 'worst').	90 days
Secondary	100mm Visual analogue scale of patients' reported overall satisfaction with their phonetics	Patients' reported overall satisfaction with their phonetics using visual analogue scale (a measurement instrument represented in a straight horizontal line of fixed length, 100 mm. The ends are defined as the extreme limits of the parameter to be measured (satisfied and unsatisfied). Orientated from the left 'best' to the right 'worst').	90 days