None listed
Conditions
Interventions
Intervention1: CAD-CAM fabricated provisional prosthesis: Duration: 3 months.
CAD-CAM fabricated provisional prostheses facilitates prosthesis delivery in immediate functional loading protocols. The p
Sponsors
International Team For Implantology
Eligibility
Inclusion criteria
Inclusion criteria: Patients should be of minimum 18 years to be included in the study. - Patient with edentulous maxilla - Presence of natural teeth or dentures in the mandibular arch - Presence of adequate primary stability during implant placement. - Adequate bone volume to place at least 4 implants with a standard diameter & at least 6 mm in length. - Presence of at least 6mm (height) of bone in the distal most prosthetic position (in the region of 2nd premolar or 1st molar). - Presence of at least 8 mm (height) and 6 mm (width) of bone in the anterior region to place an implant of a regular diameter with a minimum length of 8 mm. - Presence of healed maxillary edentulous ridge (at least 3 months post extraction).
Exclusion criteria
Exclusion criteria: Self reported history of bruxism - Uncontrolled diabetes (HbA1c >7.5 mg/dl) - History of irradiation in the head and neck region - Inability to comply with annual implant maintenance follow up - Ridge profile not allowing the placement of a fixed prostheses. - Presence of systemic disease that contraindicates implant placement. - Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the evaluation of prosthetic complications of CAD-CAM fabricated and denture-conversion prosthesis using modified USPHS scores at 3 months of function.Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival rates: To evaluate implant survival rates of tilted and axially placed implants at 1 year, 3 years and 5 years . VAS Scores, OHIP-14 scores and Operator based preferences.Timepoint: 1 year, 3 years and 5 years;Prosthetic Level: Incidence of chipping of the final prostheses, fracture of abutment/ crown or frame work, fracture of veneering ceramic, occlusal roughness, loss of retention (loosening of crown or abutment screw) and the contour of restoration will be evaluated at 4 weeks after insertion of final prosthesis and at 1 year, 3 years and 5 years after function for final prosthesis using the Modified USPS scores. Timepoint: 4 weeks, 1 years, 3 years and 5 years;Implant Level: Fracture of screw and implant will be evaluated at 4 weeks after insertion of final prosthesis (BL1) and at 1 year, 3 years and 5 years. Timepoint: 4 weeks, 1 years, 3 years and 5 years;PROMS: - VAS scores based questionnaires about maintenance of oral hygiene, ability to speak, comfort and aesthetics will be evaluated at insertion of interim prosthesis ( Visit 3; prior to implant insertion,) at baseline and 3 months after use of provisional prostheses. Similarly VAS scores will be evaluated at the time of insertion of final prostheses (BL1) and at 1, 3 and 5 years after function. - OHIP-14 will be evaluated at insertion of interim prosthesis (Visit 3; prior to implant insertion, at baseline and 3 months after use of provisional prostheses. Similarly VAS scores will be evaluated at the time of insertion of final prostheses and at 1, 3 and 5 years after function. Timepoint: 1 year, 3 years and 5 years;Operator based preferences: VAS scores based questionnaires for operator based preferences with respect to the ease of surgery and insertion of CAD-CAM fabricated provisional prostheses and denture conversion prostheses will be assessed after the insertion of provisional prostheses. Timepoint: 3 months;Clinical outcomes: The following clinical outcomes will be evalua | — |
Countries
India
Contacts
Public ContactFarha Rizwan
M.A.Rangoonwala College of Dental Sciences and Research Center, Pune
Outcome results
None listed