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The aim of this study is assessing the effect of provisionalization with a glass fiber composite framework on patients' quality of life and bone height changes before the insertion of a definitive PEKKTON framework of screw-retained maxillary implant-supported prosthesis at a one-year follow-up period.
Patient grouping:
Group I, (control): patients obtained an Implant-supported, full arch maxillary definitive prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization.
Group II, (intervention): Patients obtained an Implant-supported full arch maxillary provisional prosthesis protocol utilizing 6 implants for constructing a resin glass fiber composite framework followed by a definitive PEKKTON framework.
Preparation of a scan appliance:
Virtual planning, surgical guide fabrication, and Implant placement
Prosthetic procedures:
After 1 Month:
Group I (control gp): patients obtained an Implant-supported, full arch maxillary prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization.
A. Digital impressions Scan bodies will be tightened onto the multi-unit abutments and an intraoral digital impression will be made using an IOS system after one month of implant insertion.
B. Verification jigs fabrication (digitally) The milled PMMA jig will be constructed and checked for passive seating on implants by verifying proper contact at the PMMA jig interface and the multi-unit abutments.
C. Framework fabrication:
Accordingly, if the try-in is accepted, the assigned material (PMMA) will be milled and assembled to the framework.
Group two (intervention gp): will be rehabilitated by using a glass fiber composite as a temporary framework followed by PEKKTON definitive framework.
Framework fabrication:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Provisional Prosthesis (PEKKTON as Definitive Framework) | Active Comparator | Implant-supported full arch maxillary prosthesis utilising 6 implants, for constructing PEKKTON framework without provisionalization. |
|
| Glass Fiber Reinforced Composite Framework for Provisionalization Then PEKKTON Framework | Experimental | Implant-supported full arch maxillary prosthesis utilising 6 implants, then Glass fiber composite as a temporary framework followed by PEKKTON definitive framework. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROVSIONALIZATION | Procedure | glass fiber composite as a temporary framework followed by PEKKTON definitive framework. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oral health related to quality of life | A translated form from a validated questionnaire will be used to address the Egyptian population; all patients have to answer the same questionnaire. Each answer will be given a score from 0 to 4 where the lesser the score the better the quality of life, data will be collected, and privacy will be ensured. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Bone height changes assessments | Digital periapical radiographs (Digora System) at the time of implant loading, three months, six-months, one year post-operatively will be done utilizing periapical radiographs following the standardized long cone paralleling technique and evaluated. For further standardization, the same x-ray machine will be used at 8 milliamperes and 70 kilovolts for 0.6 seconds with a focal film distance of 35 cm. Marginal bone height changes around the implants will be evaluated using the measurement software system supplied with the Digora radiographs system. |
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Inclusion Criteria:
• Completely edentulous patients with Angle's Class I maxillomandibular relationship
Exclusion Criteria:
• Patients with recent extraction (less than three months).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheta | Contact | +201224552363 | nora.sheta@dentistry.cu.edu.eg | |
| Huda Fakhry, Lecturer | Contact | +201006229611 | huda.fakhry@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Haydi Issa, PhD | faculty of dentistry, Cairo University, Egypt | Principal Investigator |
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Group I, (control): patients obtained an Implant-supported, full arch maxillary definitive prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization.
Group II, (intervention): Patients obtained an Implant-supported full arch maxillary provisional prosthesis protocol utilizing 6 implants for constructing a resin glass fiber composite framework followed by a definitive PEKKTON framework.
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The study is based on different technical procedures of framework fabrication. Since these differences are visible, the operator and the patients involved in the study cannot be blinded. But the outcome assessor and the statistician will be blinded.
| 1 year |