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This crossover clinical study will examine the impact of the framework material of implant-supported prostheses on patient satisfaction and Oral Health-Related Quality of Life (OHRQoL) with mandibular All-on-4 implant distribution. The trial will investigate subject satisfaction, OHRQoL as the primary outcome, and chewing efficiency and maximum bite force as secondary outcomes for different framework materials used in implant-supported screw-retained restorations. The first null hypothesis states no significant difference in patient satisfaction and OHRQoL between the tested prostheses. Additionally, the second null hypothesis states no significant difference in chewing efficiency and maximum bite force between the tested prostheses.
Prosthetic steps
Evaluation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | The first 9 patients will receive the PEEK prosthesis (PP) first. After 3 months, chewing efficiency, maximum bite force, patient satisfaction, and OHRQoL will be measured, and PP will be replaced by a Titanium prosthesis (TP). After another 3 months, the measurements will be repeated. |
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| study group 1 | Experimental | The second 9 patients will receive TP first, and after 3 months, measurements will be made. Then, TP was replaced by PP, and measurements will be repeated after another 3 months. This randomization will be made to reduce the effect of prosthesis type and bias |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEEK prosthesis | Device | For the PP, The PEEK framework will be constructed, the fit of the PEEK framework will be verified intraorally, and the final screw-retained prosthesis will be constructed of PMMA teeth and a visiolign pink composite estimating the gingival tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction | Patient satisfaction will be evaluated using a questionnaire based on a visual analog scale | 3 month |
| chewing efficiency | Chewing efficiency will be evaluated using the color mixing ability test | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Oral health-related quality of life (OHRQoL) | The oral health impact profile (OHIP-14) questionnaire was used to measure OHRQoL. | 3 month |
| maximum bite force (BF) | A digital BF transducer will be used to evaluate maximum BF in Newton (N) |
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Inclusion Criteria:
The inclusion criteria include
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khloud Ezzat, PhD | Lecturer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khloud Ezzat | Al Mansurah | 54790 | Egypt |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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All selected patients will receive maxillary complete dentures and mandibular screw-retained prosthesis either from PEEK or Titanium framework in a crossover design.
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| Titanium prosthesis | Device | For the TP, the framework will be milled from Ti blocks according to the virtual design of the final prosthesis framework. PMMA teeth then will be cemented, and the final prosthesis will be screwed. |
|
| 3 month |