Accuracy of Half-guided Implant Placement

NCT04854239 | Completed Phase 4

• 1 other identifier: Accuracy-Semmelweis-Perio
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial-edentulism

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Implant insertion torque

  During implant insertion

• Implant insertion torque

  During implant insertion

• Duration of implant insertion

  During implant insertion

Study Arms (2)

Machine-driven group

EXPERIMENTAL

In the machine-driven group, after guided implant bed preparation, implant insertion was performed with contra-angled handpiece.

Procedure: Half-guided implant placement

Manual group

EXPERIMENTAL

In the manual group, after guided implant bed preparation, implant insertion was performed with torque-wrench.

Procedure: Half-guided implant placement

Interventions

Half-guided implant placement PROCEDURE

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

Machine-driven group; Manual group

Eligibility Criteria

• Age: 29 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• clinically relevant diseases (e.g.: diabetes, rheumatism, cancer)
• systemic steroid or bisphosphonate use
• acute or chronic inflammatory processes

Sponsors & Collaborators

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

Study Sites (1)

Semmelweis University Department of Periodontology

Budapest, 1088, Hungary

Location

Related Publications (1)

• 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.

  PMID: 34401946 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Balint Molnar DMD, PhD, associate professor

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 22, 2021
• Study Start: January 1, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)