A Phase 4 interventional study of Half-guided implant placement in Partial-edentulism, sponsored by Semmelweis University. Completed at 1 site in Hungary. Open to participants aged 29 Years to 67 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-22.
Sponsored by Semmelweis University · Phase 4, Interventional, and Treatment
The aim of the present prospective randomized controlled study is to compare the accuracy of implant placement performed either with a surgical motor or a torque wrench as part of a half-guided surgical protocol after maxillary sinus floor augmentation.
Implant insertion with half-guided surgical protocol was utilized by surgical motor (machine-driven group) or torque wrench (manual group) in the maxilla. Forty patients were randomly divided in two study groups; 20 implants were inserted with a surgical motor and 20 implants with a torque wrench. After the healing period, accuracy comparison method between planned and actual implant positions was performed based on digital intraoral scan. Coronal, apical and angular deviation parameters, insertion time and maximum insertion torque was evaluated.
Semmelweis University is the lead sponsor of 136 studies on the registry; 54 are open to participants now.
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In the machine-driven group, after guided implant bed preparation, implant insertion was performed with contra-angled handpiece.
Procedure: Half-guided implant placement
In the manual group, after guided implant bed preparation, implant insertion was performed with torque-wrench.
Procedure: Half-guided implant placement
The surgery was performed under local anaesthesia in both groups, half-guided implant placement was carried out based on randomization.
Also known as: Guided implant placement
Global coronal implant position deviation
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Time frame: 3 months after implant placement
Global apical implant position deviation
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Time frame: 3 months after implant placement
Horizontal coronal implant position deviation
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Time frame: 3 months after implant placement
Horizontal apical implant position deviation
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Time frame: 3 months after implant placement
Angular implant position deviation
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Time frame: 3 months after implant placement
Implant insertion torque
Measurement: Insertion torque. Tool: torque wrech Unit: Ncm
Time frame: During implant insertion
Implant insertion torque
Measurement: Insertion torque. Tool: surgical motor Unit: Ncm
Time frame: During implant insertion
Duration of implant insertion
Measurement: Duration of implant insertion Tool: stopwatch Unit: seconds
Time frame: During implant insertion
Plan to share: No
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Semmelweis University