Clinical trial NCT06881199: "Acrylic Vs. Metal Palatal Coverage in Complete Dentures: Patient-Reported Outcomes"
Official title: Complete Denture Palatal Material Impact on Patients' Satisfaction and Oral Health-Related Quality of Life: a Randomized Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Complete Edentulism
Satisfaction, Patient
Quality of Life
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Eligibility Minimum Age: 45 Years Maximum Age: 80 Years Sex: All Gender-Based Inclusion: No Accepts Healthy Volunteers: Yes (if completely edentolous)

Inclusion Criteria:

* 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

Exclusion Criteria:

- 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

Primary outcomes:
measure: Patients' reported overall satisfaction with their dentures
timeFrame: 60 days
Secondary outcomes:
measure: Patients reported oral health related quality of life
timeFrame: 60 days
measure: Patients' reported overall satisfaction with their dentures during speaking.
timeFrame: 60 days
measure: Patients' reported overall satisfaction with their dentures during eating
timeFrame: 60 Days
measure: Patients' reported overall satisfaction with their dentures during drinking
timeFrame: 60 Days
measure: Patients' reported overall satisfaction with their ability to clean their dentures
timeFrame: 60 Days
measure: Patients' reported overall satisfaction with their phonetics
timeFrame: 60 Days
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan Hospital
Study officials:
References: