Comparing patient satisfaction with different dental implant frameworks
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.
This study is testing whether people who get dental implants feel more satisfied and have a better quality of life with either plastic or metal frameworks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | Female |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Mansoura) |
| Trial ID | NCT05904756 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate patient satisfaction and oral health-related quality of life (OHRQL) in individuals receiving dental implants with either polyetherketoneketone (PEKK) or metal frameworks. Ten completely edentulous patients aged 50-60 will participate, receiving a complete denture followed by an All-on-4 implant procedure. After a three-month adaptation period, patients will be assessed for satisfaction and quality of life before switching to the alternative framework for another three months. This crossover design allows for direct comparison of the two materials within the same individuals.
Who should consider this trial
Good fit: Ideal candidates are completely edentulous individuals aged 50-60 with sufficient restorative space and healthy oral conditions.
Not a fit: Patients with contraindications for implant surgery, such as those with bleeding disorders or metabolic disorders affecting osseointegration, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which framework material provides better patient satisfaction and quality of life for dental implant recipients.
How similar studies have performed: While studies comparing different dental implant materials exist, this specific crossover approach focusing on PEKK versus metal frameworks is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Mansoura
- Faculty of dentistry , Mansoura University — Mansoura, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammed E Sawy, PhD
- Email: Dr_sawy@windowslive.com
- Phone: +201061314522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.