Accuracy of Half-guided Implant Placement

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

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.

Study Overview

• Status: Completed
• Conditions: Partial-edentulism
• Intervention / Treatment: Procedure: Half-guided implant placement

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1088
    • Semmelweis University Department of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Machine-driven group; In the machine-driven group, after guided implant bed preparation, implant insertion was performed with contra-angled handpiece.	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.; Other Names: Guided implant placement
Experimental: Manual group; 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.; Other Names: Guided implant placement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Semmelweis University
• Collaborators: Institut Straumann AG; NSK Europe GmbH; Botiss Medical AG; Dicomlab Kft.; Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006); Excellence Program of the Ministry for Innovation and Technology in Hungary

Publications and helpful links

General Publications

• Orban K, Varga E Jr, Windisch P, Braunitzer G, Molnar B. Accuracy of half-guided implant placement with machine-driven or manual insertion: a prospective, randomized clinical study. Clin Oral Investig. 2022 Jan;26(1):1035-1043. doi: 10.1007/s00784-021-04087-0. Epub 2021 Aug 16.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: guided surgery; dental implants; computer-assisted surgery; accuracy; machine driven implant insertion; manual implant insertion
• Other Study ID Numbers: Accuracy-Semmelweis-Perio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No