Skip to main content
OpenTrials
Completed

NCT Number: NCT04854239

Accuracy of Half-guided Implant Placement

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Partial-edentulism

Age range

29 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Semmelweis University Department of Periodontology

Budapest, 1088, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Guided implant placement

Primary outcomes

  1. Global coronal implant position deviation

    Time frame: 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

  2. Global apical implant position deviation

    Time frame: 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

  3. Horizontal coronal implant position deviation

    Time frame: 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

  4. Horizontal apical implant position deviation

    Time frame: 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

  5. Angular implant position deviation

    Time frame: 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 outcomes

  1. Implant insertion torque

    Time frame: During implant insertion

    Measurement: Insertion torque. Tool: torque wrech Unit: Ncm

  2. Implant insertion torque

    Time frame: During implant insertion

    Measurement: Insertion torque. Tool: surgical motor Unit: Ncm

  3. Duration of implant insertion

    Time frame: During implant insertion

    Measurement: Duration of implant insertion Tool: stopwatch Unit: seconds

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2021
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.