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

NCT06881199 | Active Not Recruiting

• 1 other identifier: 10/2024/10664
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Complete Edentulism; Satisfaction, Patient; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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').

  60 days

Secondary Outcomes (6)

• Patients reported oral health related quality of life

  60 days

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

  60 days

• Patients' reported overall satisfaction with their dentures during eating

  60 Days

• Patients' reported overall satisfaction with their dentures during drinking

  60 Days

• Patients' reported overall satisfaction with their ability to clean their dentures

  60 Days

Study Arms (2)

Acrylic palate complete denture

EXPERIMENTAL

Participants will receive maxillary complete dentures with an acrylic palate

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

Other: Complete denture with an acrylic palate

Interventions

Complete denture with a metallic Co-Cr casted palate OTHER

Complete denture with a metallic Co-Cr casted palatal material

Also known as: Complete denture with an acrylic palate

Acrylic palate complete denture

Complete denture with an acrylic palate OTHER

Complete denture with an acrylic palatal material

Metal palate complete denture

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Patients with severe underlying medical conditions, including: Neuromuscular dysfunction, Auditory problems, Mental conditions, Oral pathology, Xerostomia, Tied tongue condition

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

University of Jordan Hospital

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Denture, Complete

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will not be aware of which group he/she is interviewing at the assessment session.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: March 18, 2025
• Study Start: January 16, 2024
• Primary Completion: February 20, 2025
• Study Completion: April 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)