"Acrylic Vs. Metal Palatal Coverage in Complete Dentures: Patient-Reported Outcomes"

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-16

Study Completion Date

2025-04-01

Brief Summary

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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.

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Detailed Description

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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

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Complete Edentulism Satisfaction, Patient Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 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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Acrylic palate complete denture

Participants will receive maxillary complete dentures with an acrylic palate

Group Type EXPERIMENTAL

Complete denture with a metallic Co-Cr casted palate

Intervention Type OTHER

Complete denture with a metallic Co-Cr casted palatal material

Metal palate complete denture

Participants will receive maxillary complete dentures with a metal palate

Group Type EXPERIMENTAL

Complete denture with an acrylic palate

Intervention Type OTHER

Complete denture with an acrylic palatal material

Interventions

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Complete denture with a metallic Co-Cr casted palate

Complete denture with a metallic Co-Cr casted palatal material

Intervention Type OTHER

Complete denture with an acrylic palate

Complete denture with an acrylic palatal material

Intervention Type OTHER

Other Intervention Names

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Complete denture with an acrylic palate

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes