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

Primary Purpose

Edentulous Jaw

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Polished palatal surface
Roughened palatal surface
Opened palatal surface
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Edentulous Jaw

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Jordan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Polished palate

Roughened palate

Open palate

Arm Description

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

Participants will receive maxillary complete dentures with roughened palatal surfaces

Participants will receive maxillary complete dentures with opened palatal surfaces

Outcomes

Primary Outcome Measures

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').

Secondary Outcome Measures

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.
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').
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').
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').

Full Information

First Posted
July 21, 2021
Last Updated
July 1, 2023
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT04985747
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaw

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will not be aware of which group he/she is interviewing at the assessment session.
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polished palate
Arm Type
Experimental
Arm Description
Participants will receive maxillary complete dentures with smooth palatal surfaces without modification.
Arm Title
Roughened palate
Arm Type
Experimental
Arm Description
Participants will receive maxillary complete dentures with roughened palatal surfaces
Arm Title
Open palate
Arm Type
Experimental
Arm Description
Participants will receive maxillary complete dentures with opened palatal surfaces
Intervention Type
Other
Intervention Name(s)
Polished palatal surface
Intervention Description
Polishing of the anterior palatal surface using a polisher
Intervention Type
Other
Intervention Name(s)
Roughened palatal surface
Intervention Description
Roughening of the anterior palatal surface using a sandblaster
Intervention Type
Other
Intervention Name(s)
Opened palatal surface
Intervention Description
Opening of the anterior palatal surface using acrylic bur
Primary Outcome Measure Information:
Title
100mm Visual analogue scale of patients' reported overall satisfaction with their dentures
Description
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').
Time Frame
90 days
Secondary Outcome Measure Information:
Title
OHIP-EDENT Measure
Description
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.
Time Frame
90 days
Title
100mm Visual analogue scale of patients' reported overall satisfaction with their dentures during speaking
Description
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').
Time Frame
90 days
Title
100mm Visual analogue scale of patients' reported overall satisfaction with their ability to clean their dentures
Description
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').
Time Frame
90 days
Title
100mm Visual analogue scale of patients' reported overall satisfaction with their phonetics
Description
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').
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
University of Jordan Hospital
City
Amman
ZIP/Postal Code
11942
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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