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Active, Not Recruiting

NCT Number: NCT06881199

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Complete Edentulism Behavior Health Behavior Patient Satisfaction Quality of Life Satisfaction, Patient Treatment Adherence and Compliance

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Jordan Hospital

Amman, 11942, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complete denture with a metallic Co-Cr casted palate

Other

Complete denture with a metallic Co-Cr casted palatal material

Other names: Complete denture with an acrylic palate

Complete denture with an acrylic palate

Other

Complete denture with an acrylic palatal material

Primary outcomes

  1. 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').

Secondary outcomes

  1. Patients reported oral health related quality of life

    Time frame: 60 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.

  2. Patients' reported overall satisfaction with their dentures during speaking.

    Time frame: 60 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').

  3. Patients' reported overall satisfaction with their dentures during eating

    Time frame: 60 Days

    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').

  4. Patients' reported overall satisfaction with their dentures during drinking

    Time frame: 60 Days

    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').

  5. Patients' reported overall satisfaction with their ability to clean their dentures

    Time frame: 60 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').

  6. Patients' reported overall satisfaction with their phonetics

    Time frame: 60 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').

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

Complete Denture Palatal Material Impact on Patients' Satisfaction and Oral Health-Related Quality of Life: a Randomized Crossover Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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