The Impact of Rugae Reproduction on Complete Dentures Patients' Satisfaction

University of Jordan

Status: Completed

Conditions: Edentulous Jaw

Treatments: Other: Addition of palatal rugae to the complete denture surface; Other: The removal of the palatal rugae from the complete denture surface

Study type: Interventional

Funder types: Other

Identifiers

NCT03879083

10/2019/27400

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.
• Patients aged between 45 and 80 years old.
• Patients had been completely edentulous for at least 3 months
• Patients without severe underlying medical conditions, neuromascular dysfunction, auditory problems, mental conditions, oral pathology, xerostomia, or tied tongue condition.
• Patients who approved and consented to participation.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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44 participants in 2 patient groups

With reproduction of palatal rugae

Experimental group

Description:

Participants will receive maxillary complete dentures with a reproduction of the patients's own palatal rugae to the palatal surface.

Treatment:

Other: The removal of the palatal rugae from the complete denture surface

Without reproduction of palatal rugae (smooth surface)

Active Comparator group

Description:

Participants will receive maxillary complete dentures with smooth palatal surfaces without a reproduction of the patients's own palatal rugae to the palatal surface.

Treatment:

Other: Addition of palatal rugae to the complete denture surface