Clinical Trials Directory

Trials / Unknown

UnknownNCT05904756

Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework.

Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework for All-on-four Implant Supported Fixed Detachable Prosthesis: A Crossover Study.

Status
Unknown
Phase
Study type
Observational
Enrollment
10 (estimated)
Sponsor
Mansoura University · Academic / Other
Sex
Female
Age
50 Years – 70 Years
Healthy volunteers
Accepted

Summary

The patients' satisfaction and oral health related quality of life (OHRQL) of different framework material remains uncertain. Thus, the aim of this clinical cross over study was to compare patient satisfaction and OHRQL OF polyetherketoneketone and metal framework for All-on-four implant supported fixed prosthesis

Detailed description

10 completely edentulous patients around age of 50-60 years will be selected for this study from the Outpatient Clinic, Faculty of Dentistry, Mansoura University. All selected participants will receive a new complete dentures (CD) fabricated with bilateral balanced occlusion utilizing semi-anatomical acrylic teeth. The patients were instructed to wear the dentures for 3 months to develop adequate neuromuscular control, and then, clinical performance and patient satisfaction will be evaluated. Each participant will receive 4 implants according to the "All-on-4 concept," and the implants will be immediately loaded with mandibular denture. Three months after osseointegration, patients received a definitive fixed detachable prosthesis either from PEKK or metal with composite teeth in a crossover designs. Two sets of patients will be made (10 patients/set) using random-generated numbers created by a computer program (Excel sheet). The first 10 participants will recieve metal framework first. After 3 months, patient satisfaction and OHRQoL will be measured and metal framework will be replaced by PEKK framework. After another 3 months, measurements will be repeated. The second 10 patients received PEKK first, and after 3 months, measurements will be made. Then, PEKK framework was replaced by Metal framework and measurements were repeated after another 3 months.

Conditions

Interventions

TypeNameDescription
DEVICEframework for implant supported prosthesis, fabricated from metal of polyetherketoneketoneevaluation of patient satisfaction and oral healty related quality of life

Timeline

Start date
2023-05-15
Primary completion
2024-01-04
Completion
2024-05-15
First posted
2023-06-15
Last updated
2023-10-23

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05904756. Inclusion in this directory is not an endorsement.