Accuracy of Half-guided Implant Placement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Accuracy of Half-guided Implant Placement With Machine-driven or Manual Insertion: a Prospective, Randomized Clinical Study

Conditions
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Partial-edentulism

Intervention / Treatment
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* Procedure: Half-guided implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least one edentulous maxillary premolar or molar site treated successfully by sinus floor elevation with a xenogenic bone substitute (cerabone, botiss biomaterials, Zossen, Germany) confirmed by preoperative cone-beam computed tomography full- mouth plaque and bleeding scores (FMPS and FMBS) <20% good patient compliance (including willingness to participate in the follow-up procedures) signed informed consent Exclusion Criteria: clinically relevant diseases (e.g.: diabetes, rheumatism, cancer) systemic steroid or bisphosphonate use acute or chronic inflammatory processes

Ages Eligible for Study
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Minimum Age: 29 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Forty patients were treated; implant insertion with half-guided surgical protocol was utilized by surgical motor (20 patients, machine-driven group) or torque wrench (20 patients, manual group) in the maxilla.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Machine-driven group<br>In the machine-driven group, after guided implant bed preparation, implant insertion was performed with contra-angled handpiece. | Procedure: Half-guided implant placement<br>* The surgery was performed under local anaesthesia in both groups, half-guided implant placement was carried out based on randomization.<br>* Other names: Guided implant placement;|
| Experimental: Manual group<br>In the manual group, after guided implant bed preparation, implant insertion was performed with torque-wrench. | Procedure: Half-guided implant placement<br>* The surgery was performed under local anaesthesia in both groups, half-guided implant placement was carried out based on randomization.<br>* Other names: Guided implant placement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 3 months after implant placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant insertion torque | Measurement: Insertion torque. Tool: torque wrech Unit: Ncm | During implant insertion | 
| Implant insertion torque | Measurement: Insertion torque. Tool: surgical motor Unit: Ncm | During implant insertion | 
| Duration of implant insertion | Measurement: Duration of implant insertion Tool: stopwatch Unit: seconds | During implant insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implants, computer-assisted surgery, guided surgery, accuracy, machine driven implant insertion, manual implant insertion