- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04985747
Impact of Different Palatal Contour Designs on Patients' Satisfaction and Oral Health Related Quality of Life
The Impact of Different Palatal Contour Designs on Patients' Satisfaction and Oral Health Related Quality of Life; a Crossover Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Motasum Abu-Awwad
- Phone Number: +962795455536
- Email: motasum@gmail.com
Study Locations
-
-
-
Amman, Jordan, 11942
- University of Jordan Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Polished palate
Participants will receive maxillary complete dentures with smooth palatal surfaces without modification.
|
Roughening of the anterior palatal surface using a sandblaster
Opening of the anterior palatal surface using acrylic bur
|
Experimental: Roughened palate
Participants will receive maxillary complete dentures with roughened palatal surfaces
|
Opening of the anterior palatal surface using acrylic bur
Polishing of the anterior palatal surface using a polisher
|
Experimental: Open palate
Participants will receive maxillary complete dentures with opened palatal surfaces
|
Roughening of the anterior palatal surface using a sandblaster
Polishing of the anterior palatal surface using a polisher
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
100mm Visual analogue scale of patients' reported overall satisfaction with their dentures
Time Frame: 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').
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OHIP-EDENT Measure
Time Frame: 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.
|
90 days
|
100mm Visual analogue scale of patients' reported overall satisfaction with their dentures during speaking
Time Frame: 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').
|
90 days
|
100mm Visual analogue scale of patients' reported overall satisfaction with their ability to clean their dentures
Time Frame: 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').
|
90 days
|
100mm Visual analogue scale of patients' reported overall satisfaction with their phonetics
Time Frame: 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').
|
90 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UJordan2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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