Faculty of Oral and Dental Medicine - Egyptian Russian University
Cairo, 11829, Egypt
NCT Number: NCT07360015
This research aims to compare between using OT Equator abutments for constructing implant supported fixed mandibular prosthesis with different number of screws (3 screws vs 4 screws) regarding the marginal bone height alteration around the implants through radiographic evaluation.
This study is active but is not currently recruiting participants.
Notify Me40 year–65 year
Male
Interventional
Not applicable
Cairo, 11829, Egypt
Fourteen completely edentulous male patients free from any systemic diseases that would affect bone metabolism, had no history of recent administration of chemotherapy or radiotherapy and no history of para-functional habits will be selected from out-patients clinic.
The first group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws).
The second group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws).
Pre-surgical protocol:
For each patient, upper and lower complete dentures will be constructed. Using dual CBCT scan protocol, stereolithographic surgical guide will be constructed according to virtual implant planning in the software, and the 3D surgical guide will be used to insert four implants in mandibular canines and mandibular first molar positions.
OT EQUATOR abutments will be screwed to the four implants. Denture conversion was done for temporization:
After three months of implant insertion, the final prosthesis will be constructed and then screwed to the OT Equator abutments.
For the first group one screw will be avoided and the final prosthesis will be screwed to the OT Equator abutments with 3 screws only.
For the second group and the final prosthesis will be screwed to the OT Equator abutments with 4 screws.
The DIGORA Optime intraoral sensor and a specially built acrylic template for each patient will be used to take intraoral radiographs with the standardized long cone paralleling technique to measure changes of crestal bone level around each implant. Periods of 0 (immediately after delivery of final prosthesis), 3, 6, and 9 months after delivery of final prosthesis for radiographic evaluation. Bone loss measurements will be tabulated and statistically analyzed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws).
screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws).
Time frame: 12 months
The DIGORA Optime intraoral sensor and a specially built acrylic template for each patient will be used to take intraoral radiographs with the standardized long cone paralleling technique to measure changes
Ain Shams University
Other
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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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