PROVISIONALIZATION
Procedureglass fiber composite as a temporary framework followed by PEKKTON definitive framework.
NCT Number: NCT06581354
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.
Trial opening soon.
Get Notified40 year–65 year
All sexes
Interventional
Not applicable
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.
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
h. Moderate-to-heavy daily smokers (more than ten per day)
glass fiber composite as a temporary framework followed by PEKKTON definitive framework.
Time frame: one year
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
Time frame: one year
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.
Contact information is provided by the study sponsor or research team.
Huda Fakhry, lecturer
CONTACT
sheta
CONTACT
Cairo University
Other
The Impact of Provisionalization Using Glass Fiber Reinforced Composite on Patient Satisfaction and Prosthetic Complications in Maxillary Implant-Supported Arches Restored by Definitive Pekkton Frameworks
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06576778
Edentulous Alveolar Ridge
View Trial DetailsNCT07627841
Edentulous Alveolar Ridge, Partially Edentulous Maxilla, Mandible
Cairo, New Cairo, Egypt
View Trial DetailsNCT06012071
Edentulous Alveolar Ridge
Ljubljana, Slovenia
View Trial DetailsNCT05081284
Edentulous Alveolar Ridge
Pisa, Italy
View Trial Details