Accuracy of Half-guided Implant Placement

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04854239

Enrollment

Registered

2021-04-22

Start date

2017-01-01

Completion date

2019-01-31

Last updated

2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial-edentulism

Keywords

dental implants, computer-assisted surgery, guided surgery, accuracy, machine driven implant insertion, manual implant insertion

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.

Interventions

PROCEDUREHalf-guided implant placement

The surgery was performed under local anaesthesia in both groups, half-guided implant placement was carried out based on randomization.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Patients were not aware whether implant were placed with a contra-angled handpiece or with a torque wrench. 3D implant position accuracy evaluation was performed blinded, randomization sequence was revealed after analysis.

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

29 Years to 67 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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 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
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 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

Secondary

Measure	Time frame	Description
Duration of implant insertion	During implant insertion	Measurement: Duration of implant insertion Tool: stopwatch Unit: seconds
Implant insertion torque	During implant insertion	Measurement: Insertion torque. Tool: torque wrech Unit: Ncm

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026