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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2023-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Edentulous Jaw

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

The outcomes assessor will not be aware of which group he/she is interviewing at the assessment session.

Study Groups

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Polished palate

Participants will receive maxillary complete dentures with smooth palatal surfaces without modification.

Group Type EXPERIMENTAL

Roughened palatal surface

Intervention Type OTHER

Roughening of the anterior palatal surface using a sandblaster

Opened palatal surface

Intervention Type OTHER

Opening of the anterior palatal surface using acrylic bur

Roughened palate

Participants will receive maxillary complete dentures with roughened palatal surfaces

Group Type EXPERIMENTAL

Polished palatal surface

Intervention Type OTHER

Polishing of the anterior palatal surface using a polisher

Opened palatal surface

Intervention Type OTHER

Opening of the anterior palatal surface using acrylic bur

Open palate

Participants will receive maxillary complete dentures with opened palatal surfaces

Group Type EXPERIMENTAL

Polished palatal surface

Intervention Type OTHER

Polishing of the anterior palatal surface using a polisher

Roughened palatal surface

Intervention Type OTHER

Roughening of the anterior palatal surface using a sandblaster

Interventions

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Polished palatal surface

Polishing of the anterior palatal surface using a polisher

Intervention Type OTHER

Roughened palatal surface

Roughening of the anterior palatal surface using a sandblaster

Intervention Type OTHER

Opened palatal surface

Opening of the anterior palatal surface using acrylic bur

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes