Complete EdentulismNCT06881199
"Acrylic Vs. Metal Palatal Coverage in Complete Dentures: Patient-Reported Outcomes"
A study testing Complete denture with a metallic Co-Cr casted palate and Complete denture with an acrylic palate in people with Complete Edentulism and Satisfaction, Patient, run by University of Jordan at 1 site in Jordan.
Trial summary
Conventional dentures can be uncomfortable and limit oral functionality due to the polished surfaces covering the palate and rugae areas. A randomized crossover clinical trial was conducted to compare patients' satisfaction and oral health-related quality of life when using dentures with an acrylic or metal palate. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism, Satisfaction, Patient, Quality of Life
- What is being tested?
- Complete denture with a metallic Co-Cr casted palate and Complete denture with an acrylic palate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJordan
- Study dates
- 16 Jan 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients seeking a set of conventional maxillary and mandibular complete dentures at the University of Jordan Hospital, either for the first time or as a replacement for previous dentures
- Patients aged between 45 and 80 years old
- Completely edentulous for at least 3 months
- Patients who approved and consented to participation
Who cannot join
- Patients with severe underlying medical conditions, including: Neuromuscular dysfunction, Auditory problems, Mental conditions, Oral pathology, Xerostomia, Tied tongue condition
- Patients who met the inclusion criteria but failed to sign a consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complete Denture Palatal Material Impact on Patients' Satisfaction and Oral Health-Related Quality of Life: a Randomized Crossover Clinical Trial
Conventional dentures can be uncomfortable and limit oral functionality due to the polished surfaces covering the palate and rugae areas. A randomized crossover clinical trial was conducted to compare patients' satisfaction and oral health-related quality of life when using dentures with an acrylic or metal palate. The study aimed to determine whether an acrylic palate would provide better sensory feedback and improved oral function. Participants wore each denture and completed a questionnaire. The study's results have implications for the design of complete dentures, as they highlight the importance of considering patient experiences and feedback when selecting materials. By prioritizing patient satisfaction and oral health-related quality of life, dental professionals can enhance denture treatments' effectiveness and improve patients' quality of life.
Read the detailed description
Conventional dentures have long been criticized for their discomfort and limitations in oral functionality, primarily attributed to the polished surfaces covering the palate and rugae areas. To address these concerns, a rigorous randomized crossover clinical trial was meticulously conducted to compare the subjective experiences of patients wearing dentures with either an acrylic or metal palate.
The primary objective of this study was to evaluate patients' satisfaction and oral health-related quality of life while wearing dentures with different palate materials. Specifically, researchers sought to ascertain whether the use of an acrylic palate could offer superior sensory feedback and enhance overall oral function compared to traditional metal palates.
Participants enrolled in the study were required to wear both types of dentures consecutively and subsequently complete a comprehensive questionnaire designed to capture their subjective experiences and perceptions. The questionnaire encompassed various aspects, including comfort, ease of speech, ability to chew and swallow, and overall satisfaction with the dentures.
- Conditions
- Complete Edentulism, Satisfaction, Patient, Quality of Life
- Being tested
- Complete denture with a metallic Co-Cr casted palate, Complete denture with an acrylic palate
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete denture with a metallic Co-Cr casted palateOther
Also called Complete denture with an acrylic palate
Complete denture with a metallic Co-Cr casted palatal material
Complete denture with an acrylic palateOther
Complete denture with an acrylic palatal material
| Study group | Role | What they receive |
|---|---|---|
| Acrylic palate complete denture | Experimental | Participants will receive maxillary complete dentures with an acrylic palate Receives: Other: Complete denture with a metallic Co-Cr casted palate |
| Metal palate complete denture | Experimental | Participants will receive maxillary complete dentures with a metal palate Receives: Other: Complete denture with an acrylic palate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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').
Measured: 60 days
Secondary outcomes (6)
Patients reported oral health related quality of life
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.
Measured: 60 days
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').
Measured: 60 days
Patients' reported overall satisfaction with their dentures during eating
Patients overall satisfaction rate during eating 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').
Measured: 60 Days
Patients' reported overall satisfaction with their dentures during drinking
Patients overall satisfaction rate during drinking 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').
Measured: 60 Days
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').
Measured: 60 Days
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').
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start16 Jan 2024
- Primary completion20 Feb 2025
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will randomly be allocated to either group A/B or B/A. Group A: Patients receiving an acrylic complete denture Group B: Patients receiving a metal palate complete denture 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 material. After the second period the same process will be repeated.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Motasum Abu-Awwad, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881199
- Sponsor's protocol ID
- 10/2024/10664
- Status last verified
- Mar 2025
- First submitted
- 3 May 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study data will not be made publicly available due to ethical considerations, patient privacy concerns, and institutional policies. However, aggregate results may be published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Denture Palatal Material Impact on Patients' Satisfaction and Oral Health-Related Quality of Life: a Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT06881199
- Acronym / sponsor ID
- 10/2024/10664
- Conditions
- Complete Edentulism, Satisfaction, Patient, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conventional dentures can be uncomfortable and limit oral functionality due to the polished surfaces covering the palate and rugae areas. A randomized crossover clinical trial was conducted to compare patients' satisfaction and oral health-related quality of life when using dentures with an acrylic or metal palate. The study aimed to determine whether an acrylic palate would provide better sensory feedback and improved oral function. Participants wore each denture and completed a questionnaire. The study's results have implications for the design of complete dentures, as they highlight the importance of considering patient experiences and feedback when selecting materials. By prioritizing patient satisfaction and oral health-related quality of life, dental professionals can enhance denture treatments' effectiveness and improve patients' quality of life.
Detailed description
Conventional dentures have long been criticized for their discomfort and limitations in oral functionality, primarily attributed to the polished surfaces covering the palate and rugae areas. To address these concerns, a rigorous randomized crossover clinical trial was meticulously conducted to compare the subjective experiences of patients wearing dentures with either an acrylic or metal palate.
The primary objective of this study was to evaluate patients' satisfaction and oral health-related quality of life while wearing dentures with different palate materials. Specifically, researchers sought to ascertain whether the use of an acrylic palate could offer superior sensory feedback and enhance overall oral function compared to traditional metal palates.
Participants enrolled in the study were required to wear both types of dentures consecutively and subsequently complete a comprehensive questionnaire designed to capture their subjective experiences and perceptions. The questionnaire encompassed various aspects, including comfort, ease of speech, ability to chew and swallow, and overall satisfaction with the dentures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will randomly be allocated to either group A/B or B/A. Group A: Patients receiving an acrylic complete denture Group B: Patients receiving a metal palate complete denture 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 material. After the second period the same process will be repeated.
| Arm | Type | Receives |
|---|---|---|
| Acrylic palate complete denture | Experimental | Other: Complete denture with a metallic Co-Cr casted palateParticipants will receive maxillary complete dentures with an acrylic palate |
| Metal palate complete denture | Experimental | Other: Complete denture with an acrylic palateParticipants will receive maxillary complete dentures with a metal palate |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients seeking a set of conventional maxillary and mandibular complete dentures at the University of Jordan Hospital, either for the first time or as a replacement for previous dentures
- Patients aged between 45 and 80 years old
- Completely edentulous for at least 3 months
- Patients who approved and consented to participation
Key exclusion criteria (2 listed)
- Patients with severe underlying medical conditions, including: Neuromuscular dysfunction, Auditory problems, Mental conditions, Oral pathology, Xerostomia, Tied tongue condition
- Patients who met the inclusion criteria but failed to sign a consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete denture with a metallic Co-Cr casted palateAlso: Complete denture with an acrylic palateComplete denture with a metallic Co-Cr casted palatal material | Other | Acrylic palate complete denture |
| Complete denture with an acrylic palateComplete denture with an acrylic palatal material | Other | Metal palate complete denture |
Primary outcome
Patients' reported overall satisfaction with their dentures
Time frame: 60 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').
6 secondary outcomes
Patients reported oral health related quality of life
Time frame: 60 days
Patients' reported overall satisfaction with their dentures during speaking.
Time frame: 60 days
Patients' reported overall satisfaction with their dentures during eating
Time frame: 60 Days
Patients' reported overall satisfaction with their dentures during drinking
Time frame: 60 Days
Patients' reported overall satisfaction with their ability to clean their dentures
Time frame: 60 Days
Patients' reported overall satisfaction with their phonetics
Time frame: 60 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No. The study data will not be made publicly available due to ethical considerations, patient privacy concerns, and institutional policies. However, aggregate results may be published in peer-reviewed journals.
Related trials for Complete Edentulism
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Recruiting
Accuracy of Complete-Arch Implant Scans Using Non Calibrated Splinting Scanbodies
Edentulism Complete
Active, not recruiting
Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis.
Complete Edentulism
Not yet recruiting
Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures
Edentulism
Recruiting
Nutritional Intervention for Older Adults With Complete Dentures
Edentulism Complete, Denture, Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete denture with a metallic Co-Cr casted palate and Complete denture with an acrylic palate in people with Complete Edentulism and Satisfaction, Patient, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' reported overall satisfaction with their dentures (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.