PROVSIONALIZATION
Procedureglass fiber composite as a temporary framework followed by PEKKTON definitive framework.
NCT Number: NCT06576778
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.
Trial opening soon.
Get Notified40 year–65 year
All sexes
Interventional
Not applicable
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.
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
glass fiber composite as a temporary framework followed by PEKKTON definitive framework.
Time frame: 1 year
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.
Time frame: 1 year
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.
Contact information is provided by the study sponsor or research team.
Cheta
CONTACT
Huda Fakhry, Lecturer
CONTACT
Cairo University
Other
The Impact of Provisionalization Using Fiber-Reinforced Composite on the Quality of Life and Bone Height Changes in Maxillary Implant Supported Arches Restored by Final PEKKTON Frameworks: A Randomized Controlled Trial
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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.
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