Accuracy of Half-guided Implant Placement

Phase 4

Completed

• Conditions: Partial-edentulism
• Interventions: Procedure: Half-guided implant placement

• Registration Number: NCT04854239
• Lead Sponsor: Semmelweis University

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2021-04
• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-16
• Last Update Submitted: 2021-04-16
• Study First Posted: 2021-04-22
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Machine-driven group	Half-guided implant placement	In the machine-driven group, after guided implant bed preparation, implant insertion was performed with contra-angled handpiece.
Manual group	Half-guided implant placement	In the manual group, after guided implant bed preparation, implant insertion was performed with torque-wrench.

Primary Outcome Measures

Name	Time	Method
Global apical implant position deviation	3 months after implant placement	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
Horizontal coronal implant position deviation	3 months after implant placement	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
Global coronal implant position deviation	3 months after implant placement	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
Horizontal apical implant position deviation	3 months after implant placement	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
Angular implant position deviation	3 months after implant placement	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

Secondary Outcome Measures

Name	Time	Method
Implant insertion torque	During implant insertion	Measurement: Insertion torque. Tool: surgical motor Unit: Ncm
Duration of implant insertion	During implant insertion	Measurement: Duration of implant insertion Tool: stopwatch Unit: seconds

Trial Locations

Locations (1)

Semmelweis University Department of Periodontology; 🇭🇺 Budapest, Hungary