An interventional study of Vita Enamic (hybrid dental ceramic) and lithium disilicate glass-ceramic in Prosthesis Survival, sponsored by Cairo University. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Cairo University · Not applicable, Interventional, and Prevention
The aim of this study is to assess the effect of the newly introduced (hybrid dental ceramic) superstructure materials, Vita Enamic versus IPS Emax on implant stability, patient satisfaction and crestal bone loss.
This study will be conducted on patients requiring single implant replacement in the maxillary premolar area, admitted to the Outpatient Clinic of Fixed Prosthodontics Department, Faculty of Oral and Dental medicine, Cairo University.
After a period of healing of 6 months, an implant abutment of accurate diameter and angulation will be placed to fit precisely into the internal hex of the fixture after removal of the cover screw. The platform matched abutment will be then secured into its final position using the abutment screw. Alginate impression will be taken and poured into dental stone. Using the impression transfers, impressions with polyvinylsiloxane are taken. After taking the impressions, the Impression transfers are removed and fixed to the implant replica.
Surgeons' assistants will be asked to open the sealed envelope containing the information regarding the crown placement. The impressions will be sent to dental laboratory with the result of the sealed envelope, for preparation of the future crowns, either vita enamic crowns or Ips e max crowns.
113 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's enrollment of 20 is below the median of 33 across 67 interventional studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Patients > 18 yrs. Patients with missing teeth in the maxillary premolar region. Absence of any pathological condition in the recipient site.
Stabilization phase will be performed including:
Patients who are cooperative, motivated, and hygiene conscious. Patients should have adequate ridge width (>5mm).
Exclusion Criteria:
Patients unable to undergo minor surgical procedure. Patients with history of drug abuse or metabolic drugs. Patients with history of psychiatric disorder. Patients with insufficient bone. Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
Patients with any systemic condition that may contraindicate implant therapy. Patients that may have any habits that may jeopardize the osseo-integration process, such as heavy smoking and alcoholism.
Patients with para-functional habits that produce overload on the implant such as bruxism and clenching.
Vita Enamic is a hybrid ceramic, consisting of composite and ceramic. The ceramic; compatible and high aesthetics while the composite; resilient material with low modulus of elasticity which will absorb stress and therefore decrease load on bone and eventually decrease crestal bone loss
Other: Vita Enamic (hybrid dental ceramic)
IPS Emax, is the mostly used ceramic superstructures in implant supported restorations.
Other: lithium disilicate glass-ceramic
Vita Enamic (hybrid dental ceramic) are provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology,
Also known as: hybrid, resin nanoceramic
All ceramic crowns (Lithium disilicate glass ceramic) milled by Computer aided design/Computer aided manufacturer (CAD/CAM) technology
Also known as: Emax CAD, IPS Emax
Implant survival rate
Implant stability and success could be affected by crestal bone loss, if the implant is stable therefore high survival rate
Time frame: 12 months
Crestal bone loss
Crestal bone loss will be measured using a Cone Beam Computed tomography to measure the amount of bone resorbed from start date, and follow up for one year
Time frame: 12 months
Peri-implant tissue response
Bleeding index, probing depth and gingival index
Time frame: 12 months
Patient satisfaction
Patients will be asked to answer a questionnaire to know whether the procedure was not satisfied, accepted, or highly satisfied
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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