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

Not Applicable

Completed

• Conditions: Edentulous Jaw
• Interventions: Other: Polished palatal surface; Other: Roughened palatal surface; Other: Opened palatal surface

• Registration Number: NCT04985747
• Lead Sponsor: University of Jordan

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.

Study Timeline

• Study Start: 2021-04-15
• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-08-02
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-01
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Open palate	Polished palatal surface	Participants will receive maxillary complete dentures with opened palatal surfaces
Polished palate	Roughened palatal surface	Participants will receive maxillary complete dentures with smooth palatal surfaces without modification.
Open palate	Roughened palatal surface	Participants will receive maxillary complete dentures with opened palatal surfaces
Roughened palate	Polished palatal surface	Participants will receive maxillary complete dentures with roughened palatal surfaces
Polished palate	Opened palatal surface	Participants will receive maxillary complete dentures with smooth palatal surfaces without modification.
Roughened palate	Opened palatal surface	Participants will receive maxillary complete dentures with roughened palatal surfaces

Primary Outcome Measures

Name	Time	Method
100mm Visual analogue scale of patients' reported overall satisfaction with their dentures	90 days	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').

Secondary Outcome Measures

Name	Time	Method
100mm Visual analogue scale of patients' reported overall satisfaction with their ability to clean their dentures	90 days	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').
OHIP-EDENT Measure	90 days	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.
100mm Visual analogue scale of patients' reported overall satisfaction with their dentures during speaking	90 days	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').
100mm Visual analogue scale of patients' reported overall satisfaction with their phonetics	90 days	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').

Trial Locations

Locations (1)

University of Jordan Hospital; 🇯🇴 Amman, Jordan