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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05904756
Enrollment
10
Registered
2023-06-15
Start date
2023-05-15
Completion date
2024-05-15
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Satisfaction

Brief 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.

Interventions

DEVICEframework for implant supported prosthesis, fabricated from metal of polyetherketoneketone

evaluation of patient satisfaction and oral healty related quality of life

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Sufficient available restorative space (from the proposed occlusal plane to soft tissue • covering residual ridge) of at least 20 mm to accommodate all types of tested prosthesis. * They had completely edentulous maxilla and mandible at least six months after the last extraction. * Sufficient residual alveolar ridge quantity and quality (D2-D3) * Maxillary and mandibular residual alveolar ridges covered by healthy non-inflamed mucosa with even compressibility. * Normal maxillo-mandibular relationship.

Exclusion criteria

All diseases or syndromes are contraindicated with implant surgery such as: * General contraindications for surgical procedures such as patients with head and neck radio therapy, patients with bleeding disorders, hepatic patients. * Patients with metabolic disorders that affect Osseo integration such as diabetes mellitus, and osteoporosis. * Long term immunosuppressive and corticosteroid drug therapy. * Abnormal detrimental habits, e.g. bruxism and clenching. * Heavy smokers and alcoholic patients. * All patients will be informed about the steps involved in this research and they will sign a written consent form of the ethical committee of faculty of dentistry Mansoura University for approval to take part in this research and come to the follow up visits.

Design outcomes

Primary

MeasureTime frameDescription
The patients' satisfaction using a visual analog scale (VAS)1 yearVAS score include, comfort with prosthesis, ease of cleaning appearance, decreased embarrassment, ease of speaking, general satisfaction of mandibular prosthesis compared to teeth and prosthesis apart of you, and decreased embracing. Higher score indicating increase satisfaction, and lower scores indicating less satisfaction.

Secondary

MeasureTime frameDescription
Oral healthy related quality of life (OHRQoL)1 yearThe arabic version of OHRQoL such as, functional limitation, physical pain, psychologic discomfort, psychologic disability, and social disability. For each item of the 14 items were never (= 1), hardly ever (= 2), occasionally (= 3), fairly often (= 4), and very often (= 5). Lower scores indicated higher OHRQoL, vice versa

Countries

Egypt

Contacts

Primary ContactMohammed E Sawy, PhD
Dr_sawy@windowslive.com+201061314522
Backup ContactSalah A Hegazy, PhD
salahhegazy@yahoo.com01227690209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026