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This study aims to evaluate the effect of provisionalization with a glass fiber composite framework on patient satisfaction and prosthetic complications before the insertion of a definitive PEKKTON framework when used under the screw-retained maxillary implant-supported prostheses at a one-year follow-up period.
Patient grouping:
Group I: (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.
Group II: (control) patients obtained an Implant-supported, full arch maxillary definitive prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization.
Preparation of a scan appliance:
Virtual planning, surgical guide fabrication, and Implant placement
Prosthetic procedures: After 1 Month:
Framework fabrication:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no provisional prosthesis, pekkton is a definitive framework. | Active Comparator | Implant-supported, full-arch maxillary prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization |
|
| Glass fiber composite framework for provisionalization then pekkton framework. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROVISIONALIZATION | Procedure | glass fiber composite as a temporary framework followed by PEKKTON definitive framework. |
|
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction | During the 12-month follow-up period as follows (3 months after delivery, 6 months after delivery, and 12 months after delivery), Patient satisfaction for Implant-supported screw-retained full arch maxillary provisional prosthesis with early loading protocol utilizing 6 implants for constructing a resin glass fiber composite followed by (PEKKTON) framework will be registered and calculated by Questionnaire | one year |
| Measure | Description | Time Frame |
|---|---|---|
| prosthetic complications | During the 12-month follow-up period as follow( 3 months after delivery, 6 months after delivery, and 12 months after delivery), Prosthetic complications for Implant-supported screw-retained full arch maxillary provisional prosthesis with early loading protocol utilizing 6 implants for constructing a (PEKKTON) framework will be registered and calculated according to the following events: screw loosening of the abutment, screw loosening of the prosthesis, fracture of the screw of the abutment, fracture of the screw of the prosthesis, abutment fracture, framework fracture, fracture of acrylic resin denture, loss of cover of access hole, prosthetic teeth fracture and remake of the prosthesis, occlusal discrepancies, maxillary and mandibular denture relining if needed, pain. |
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Inclusion Criteria:
a. Completely edentulous patients with Angle's Class I maxillomandibular relationship b. Age ranges from 40 to 65 years old. c. Adequate zone of keratinized attached mucosa (≥ 8mm) over the maxillary crest.
d. Absence of any medical disorder that could complicate the surgical phase or affect osseointegration.
e. The patient must have enough bone height for implants, a minimum length of bone f. 12 mm, and a minimum diameter of bone 6 mm. g. Patients with good oral hygiene. h. Complete denture wearer. i. Adequate interarch space for screw-retained prosthesis. j. Absence of any intra-oral pathological condition.
Exclusion Criteria:
- a. Patients with recent extraction (less than three months). b. Patients with an inflamed ridge or candida infection c. Patients with the flabby ridge. d. Para functional habits. e. Cancer patients receiving chemotherapy and/or radiotherapy. f. Patients with uncontrolled diabetes, assessed by measuring glycosylated hemoglobin (HbA1c ≥ 7) g. Potentially uncooperative patients who are not willing to go through the proposed interventions.
h. Moderate-to-heavy daily smokers (more than ten per day)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| sheta | Contact | +201224552363 | nora.sheta@dentistry.cu.edu.eg | |
| Huda Fakhry, lecturer | Contact | +201006229611 | huda.fakhry@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| rana shehata, phd | faculty of dentistry Cairo university -Egypt | Principal Investigator |
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sharing the main point of methodology and the final results
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Group I: Intervention will be treated using a glass fiber composite as a temporary framework followed by PEKKTON definitive framework.
Group II: Controls will be treated using PEKKTON definitive framework (no provisionalization).
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The study will be based on different technical procedures for the fabrication of the frameworks. Since these differences are visible, the operator and the technician involved in the study as well as the outcome assessor cannot be blinded. But the statistician and patients will be blinded.
| one year |