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Active Not RecruitingNCT07360015

Radiographic Evaluation of Bone Level Evaluation Around Implants in All on Four Hybrid OT Restorations With Different Number of Screws

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Ain Shams University · Academic / Other
Sex
Male
Age
40 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHEROT Equator abutments with 3 screws.screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws).
OTHEROT Equator abutments with 4 screws.screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws).

Timeline

Start date
2024-12-03
Primary completion
2025-03-10
Completion
2026-02-01
First posted
2026-01-22
Last updated
2026-01-22

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07360015. Inclusion in this directory is not an endorsement.