Accuracy of Half-guided Implant Placement

Partial-edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854239
• Other study ID #: Accuracy-Semmelweis-Perio
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: April 2021
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 29 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Partial-edentulism

Intervention

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.

Locations

Country	Name	City	State
Hungary	Semmelweis University Department of Periodontology	Budapest

Sponsors (7)

Lead Sponsor	Collaborator
Semmelweis University	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

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Implant insertion torque	Measurement: Insertion torque. Tool: torque wrech Unit: Ncm	During implant insertion
Secondary	Implant insertion torque	Measurement: Insertion torque. Tool: surgical motor Unit: Ncm	During implant insertion
Secondary	Duration of implant insertion	Measurement: Duration of implant insertion Tool: stopwatch Unit: seconds	During implant insertion